Clinical Nutrition 40 (2021) 404e411

Contents lists available at ScienceDirect

Clinical Nutrition
journal homepage: http://www.elsevier.com/locate/clnu

Randomized Control Trials

Traditional Brazilian diet and extra virgin olive oil reduce symptoms of
anxiety and depression in individuals with severe obesity:
Randomized clinical trial
Andrea Batista de Sousa Canheta a, d, Annelisa Silva e Alves de Carvalho Santos b, d,

sio de Souza c, d, Erika Aparecida Silveira a, *
Jacqueline Dane
a
s (UFG), Brazil
Graduate Program in Health Sciences, Faculty of Medicine, Federal University of Goia
b
United Faculty of Campinas (Unicamps/Goia
s), Brazil
c
Course of Nutrition, University of North Parana
(UNOPAR - Londrina/PR), Brazil
d
Faculty of Education, Federal University of Goia
s (UFG), Brazil

a r t i c l e i n f o s u m m a r y

Article history: Rational & objective: Although the relationship between obesity, anxiety and depression is known, the
Received 2 September 2019 clinical benefits of nutrition therapy in individuals with obesity have been scarcely studied. This study
Accepted 26 May 2020 assessed the effectiveness of a traditional Brazilian diet (DieTBra) and extra virgin olive oil (EVOO) on the
symptoms of anxiety and depression in severe obese participants.
Keywords: Method: This was a parallel randomized clinical trial in adults with severe obesity (Body Mass Index -
Severe obesity
BMI
35 kg/m2), DietBra Trial. Participants were randomized into three intervention groups in a ratio of
Diet therapy
1: 1: 1 and followed up for 12 weeks. The three intervention groups were: 1) DieTBra, 2) 52 mL/day
Olive oil
Depressive symptoms
EVOO, and 3) DieTBra þ52 mL/day EVOO. The symptoms of anxiety and depression were assessed by the
Anxiety Hospital Anxiety and Depression Scale. The outcome variables were: anxiety, depression and simulta-
neous anxiety and depression in the same individual.
Results: 149 severe obese individuals were randomized. The mean BMI was 46.3 ± 6.5 kg/m2 with a
mean age of 38.9 ± 8.7 years. After randomization, individuals on medication for depression and anxiety
were excluded, totaling 129 at baseline, with 44:43:42 per group. At the end of 12 weeks 113 individuals
completed the study. There was a significant reduction of symptoms for the three groups: EVOO, DieTBra
and DieTBra þ EVOO, respectively: anxiety 38.23% (p ¼ 0.019), 45.83% (p¼<0.014), 33.33% (p < 0.013)
depression 55.17% (p¼<0.001), 50.00% (p¼<0.007), 34.61% (p¼<0.035), and anxiety/depression 57.69%
(p¼<0.001), 66.67% (p¼<0.014), 27.78% (p¼<0.013).
Conclusions: Both DieTBra and olive oil interventions were effective in reducing symptoms of anxiety
and depression in severe obese adults. These interventions can be integrated with clinical protocols for
treatment of symptoms of anxiety and depression in severe obese individuals.
Trial registration: Clinicaltrials.gov NCT02463435.
© 2020 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

1. Introduction
Obese individuals have increased risk of developing depression
[1e4]. The excess of adiposity results in metabolic abnormalities
such as changes in the levels of cortisol, leptin, adiponectin and
resistin that act on the central nervous system affecting mood,
culminating in anxiety and depression [5,6]. On the other hand,
* Corresponding author.
E-mail address: erikasil@terra.com (E.A. Silveira).
mood changes affect food behavior and level of physical activity,
making the subject more vulnerable to the development of obesity
indicating the bidirectional relationship between mood and obesity
[3,7e9].
However, the psychological implications of diet in individuals
who are being treated for obesity or who experienced weight
reduction are still little clarified, with conflicting published re-
sults. Some studies have shown that a reduction in the con-
sumption of sugar and fat for an extended period may increase
symptoms of anxiety and depression [5,10,11]. In addition,

https://doi.org/10.1016/j.clnu.2020.05.046
0261-5614/© 2020 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.
 A.B.S. Canheta et al. / Clinical Nutrition 40 (2021) 404e411
various studies have demonstrated a positive association be-
tween weight loss and improvement of depressive symptoms
[6,12] and anxiety [13,14], or the reduction of depressive symp-
toms, but not anxiety [15].
The dietary pattern is an important factor involved in obesity,
which is also related to mood states [16]. The Mediterranean diet
(MedDiet) has been associated with lower risk of depressive
symptoms [17], while a diet with high energy density, coming
mainly from processed and ultra-processed foods, is associated
with a worsening of these symptoms [18]. Part of the benefits of the
MedDiet has been attributed to the effects of antioxidant properties
of extra virgin olive oil, which is important for the reduction of
oxidative stress and improvement of mood [18]. However, such
benefits require investigations in randomized clinical trials to
examine the effect of olive oil in the reduction of these symptoms.
The traditional Brazilian diet (DieTBra) received recognition in
the Brazilian Food Guidelines published from Ministery of Health
[19]. It is characterized by the consumption of healthy foods, such
as greens, vegetables, fresh fruit and minimally processed foods
[20,21,23e26]. The antioxidant properties present in foods such as
vegetables and fruits are considered protective factors against
depression [22]. Despite the benefits of healthy dietary patterns for
psychological health, there is no research and randomized
controlled trial that has evaluated the effect of dietary in-
terventions on the symptoms of anxiety and depression in severely
obese adults. This study has advances due the inclusion and ana-
lyses of two potentially beneficial dietary interventions in reducing
the symptoms of anxiety and depression: Extra virgin olive oil and
DieTBra. Accordingly, it is relevant to develop research on non-
pharmacological therapies that contribute to the remission of
these symptoms. Thus, the objective of this study is to assess the
effect of an intervention with DieTBra and extra virgin olive oil on
symptoms of anxiety and depression in individuals with severe
obesity.
2. Materials and methods
2.1. Study design and data collection
This was a randomized clinical trial, part of the main study
entitled “Effect of nutritional intervention and olive oil in severe
obesity” (DieTBra Trial) [23e26]. The clinical trial was registered on
the platform ClinicalTrials.gov (NCT02463435).
Data collection took place between June 2015 and February

s
2016, in the Clinical Research Unit of the Federal University of Goia
(UFG) in partnership with the Outpatient Clinic of Nutrition in Se-
vere Obesity (ANOG) of Hospital das Clínicas (HC), UFG. All par-
ticipants come to the ANOG from primary health care of the
Brazilian Unified Health System (UHS), city of Goia ^nia, Capital of
Goia
s State, Midwest Brazil.
2.2. Inclusion and exclusion criteria
Individuals with severe obesity (Body Mass Index - BMI
35 kg/
m2), between 18 and 65 years of age, living in Goia ^nia and metro-
politan region, were included in the study. Individuals with BMI
<35 kg/m2; history of bariatric surgery; nutritional treatment in the
last two years; pregnant women; infants; with allergy to some type
^nia or the metropolitan region; and using
of oil; not residing in Goia
medications for anxiety or depression according to the Anatomical
Therapeutic Chemical (ATC) Classification System [27] were
excluded.
405
2.3. Participants, randomization and study phases
A total of 229 individuals were recruited, of which 152 were
considered eligible and signed an informed consent form. Before
randomization there were two withdrawals for health reasons and
lack of time. In the main study, 149 participants were randomized
in a proportion of 1:1:1 in three intervention groups: 1) 52 mL/day
of olive oil (EVOO, n ¼ 50); 2) Prescription of individualized diet
based on the traditional Brazilian diet (DieTBra, n ¼ 49); and 3) the
two interventions together (DieTBra þ EVOO, n ¼ 50). Randomi-
zation was performed by the same researcher during the study, in a
separate room, according to random list generated by computer
(www.randomization.com).
For the present study, 20 individuals who were using medica-
tions for anxiety or depression were excluded from the analysis,
totaling 129 participants at baseline (LB). The participants were
followed up for 12 weeks through monthly visits. At the end of
follow-up, participants repeated all data collected at baseline.
There were 16 losses on the following up, and the present study
ended with 113 participants: EVOO (n ¼ 36), DieTBra (n ¼ 38) and
DieTBra þ EVOO (n ¼ 39) (Fig. 1).
2.4. Interventions
EVOO group participants were instructed to maintain their
usual food intake and consume 52 mL daily of extra virgin olive oil
with acidity <0.2%, dispensed in four 13-mL sachets. The package
with enough sachets for four weeks was delivered at the end of
each consultation. In each return consultation, the individual was
instructed to bring the sachets consumed and not consumed to
evaluate the adherence to the intervention.
The DieTBra group received traditional Brazilian diet prescrip-
tion which is a healthy dietary pattern characterized as plant-based
with vegetables, rice (white or brown), beans, and small amount of
low fat meat (red, fish or chicken) in main meals, dairy products,
types of bread and fruits in the small meals and low consumption of
processed foods [19,23e26]. The diet was prescribed individually,
with 4e6 daily meals. The foods were divided into food groups with
standard portions, accompanied by a list of food replacements. The
prescription was held with the objective of reducing the initial body
weight by 5e10%. After defining the individual weekly weight
reduction goal (0.5e1.0 kg/week), the daily calorie reduction was
determined (550e1100 kcal/day) [28]. With this purpose, the total
energy value (TEV) was calculated, considering the resting energy
expenditure (REE) using an equation developed for individuals
with severe obesity [29]. The total energy expenditure (TEE) was
calculated by multiplying REE by the activity factor (AF), obtained
through the Global Physical Activity Questionnaire (GPAQ) and the
thermic effect of food (TEF) [30]. The macronutrient distribution of
the TEV followed the guidelines of the Institute of Medicine [31].
The DieTBra þ EVOO group received, besides the dietary inter-
vention described previously, a supplement of 52 mL extra virgin
olive oil, distributed in four 13-mL sachets. The supplementation
resulted in an increased caloric intake of 468 kcal/day which was
discounted in food portions of the prescribed diet, to ensure an
isocaloric prescription in relation to the DieTBra group.
2.5. Blinding
In nutritional intervention studies, blinding is considered
practically impossible due to the nature of the intervention itself.
However, to minimize information bias between the recruited
participants, each group was attended at different days. Another
caution was the masking of the sachets containing olive oil as a
406 A.B.S. Canheta et al. / Clinical Nutrition 40 (2021) 404e411

Fig. 1. Flowchart of the study. Note. EVOO ¼ Normal diet plus supplementation with extra virgin olive oil; DieTBra ¼ traditional Brazilian diet; Diet þ EVOO ¼ traditional Brazilian
diet (DieTBra) plus supplementation with extra virgin olive oil. * Use of antidepressant medications according to ATC ¼ the Anatomical Therapeutic Chemical Classification System.

dietary supplement. At no time was it mentioned to participants Classification Criteria of the Brazilian Association of Market
that the food supplement was olive oil. Research Companies - ABEP [35].

2.8. Anthropometric variables

2.6. Evaluation of symptoms of anxiety and depression
Weight and height were measured to calculate the BMI. Weight
Anxiety and depression were assessed by the Hospital Anxiety
was measured in kilograms, using a digital electronic scale
and Depression Scale (HADS) [32,33] at baseline and at the End
(WELMY), with a capacity of 200 kg and precision of 100 g, duly
(Week 12). The HADS is a validated and widely used instrument in
calibrated. A stadiometer with a precision of 0.1 cm was used for
clinical studies [4,34]. Scores above nine points in the subscale of
measuring height. The calculation and classification of BMI fol-
anxiety or depression indicate the presence of symptoms. For
lowed the recommended of the WHO [16].
purposes of analysis, three different outcomes were considered: 1)
anxiety; 2) depression; and 3) anxiety/depression simultaneously.
2.9. Lifestyle variables

2.7. Sociodemographic variables
The following sociodemographic data was collected: sex,
age, marital status, education, and economic class. The eco-
nomic class was assessed according to the Economic
Physical activity was assessed in two moments (baseline and
end of the study) using a triaxial accelerometer (ActiGraph model
wGT3X) and ActiLife 6 software. Physical activity was considered
adequate when the individual reached 150 min or more per week in
moderate and/or vigorous physical activities lasting at least 10
 A.B.S. Canheta et al. / Clinical Nutrition 40 (2021) 404e411
consecutive minutes, as recommended by the World Health Orga-
nization [16].
2.10. Food consumption
Food consumption data was collected and analyzed according to
the Multiple Pass Method with three 24-h recalls (R24H) both at
the baseline and at the end of the follow-up. Food measurements
were converted to homemade measures and later converted to
grams or milliliters using conversion tables available in Brazilian
literature.
2.11. Quality control
The research team was composed of nutritionists, psychologist,
physiotherapist, pharmacist and nutrition academics. All the
members of the team were trained and skilled in applying the data
collection instruments and conduction of the proposed in-
terventions. Nutritionists were extensively trained to standardize
interventions and diet plan prescription. Standard operating pro-
cedures (SOPs) were developed to standardize each step of data
collection. A pilot study was conducted to test the collection of
outcome variables.
2.12. Statistical analysis
The data bank was double-entry typed in the EPI DATA® 3.1
program for data consistency checking. Statistical analyzes were
performed in the STATA/SE 12.1 program.
The following statistical tests were used: McNemar's test,
Pearson's chi-square and Fisher's exact test. The percentage of
reduction of depression, anxiety and depression and anxiety
concomitantly were assessed in the same individual according to
the intervention group.
As a possible co-variable that could affect the outcome variables,
the participants' body weight was analyzed and classified as:
weight reduction, gain or maintenance. The weight reduction var-
iable was calculated by the weight difference at the final moment
and the initial moment.
The reduction of symptoms was calculated by the difference
between final and initial time for all outcome variables, being: 1
(reduced), 0 (maintained) and þ1 (occurrence of depression and
anxiety symptoms). For the purpose of analysis, the reduction
variables were dichotomized into yes (reduced), and not reduced.
In this calculation, only the participants who completed the study
were taken into account, due to the need of information on variable
outcomes at the initial and final moments.
A significance level of 5% was set. The effect size of the outcomes
were calculated for the variables with p < 0.05, using the Cohen's
d Test (www.uccs.edu/lbecker).
2.13. Ethical aspects
The study was approved by the Research Ethics Committee of
the UFG HC (CEP/HC/UFG), opinion no. 747792. All ethical aspects
were respected according to Resolution CNS466/12 (CNS, 2013) and
the Declaration of Helsinki. The study is in accordance with the
recommendations of the Consolidated Standards of Reporting Trials
(CONSORT). All study participants signed an Informed Consent
Form (ICF). After the end of the follow-up the participants were
referred to ANOG, where they continued receiving nutritional
counselling.
407
3. Results
At baseline, 129 severe obese individuals participated and the
average age was 38.9 ± 8.7 years and BMI was 46.3 ± 6.5 kg/m2. The
characterization of all obese individuals according to the variables
studied are described in Table 1. There was no statistically signifi-
cant difference for kilocalories, macronutrients (protein, lipids,
carbohydrates), and olive oil consumption among the three inter-
vention groups (data not shown). The physical activity level also did
not show statistical significant difference among the three inter-
vention groups at baseline.
When comparing the prevalence of the outcomes at the end of
the study, there was no statistically significant difference in the
three intervention groups. In the comparison between two groups,
there was a lower prevalence of symptoms of anxiety in the DieTBra
group compared to the EVOO group (p ¼ 0.037) (Table 2).
The three intervention groups displayed a statistically signifi-
cant reduction in the symptoms of anxiety, depression and anxiety/
depression, when comparing the baseline and the end of the study.
A higher change occurred in the DieTBra group for anxiety and
depression with a reduction of 66.67, 95% CI -34.75 to 93.32,
p ¼ 0.014. In the EVOO group, the highest change between the
outcomes was for anxiety and depression with a reduction of 57.69,
95% CI -29.88 to 80.25, p < 0.001. In the DieTBra þ EVOO group,
the highest change between outcomes was observed in the
reduction of depression symptoms (34.61, 95% CI -7.48 to 70.10,
p ¼ 0.035) (Table 3).
In the stratified analysis of weight loss at the end of follow-up
there was no significant difference in the reduction of symptoms
of depression and anxiety among individuals who maintained,
gained or reduced body weight, both in the comparison between
the three groups and in the comparison between two groups
(Table 4).
Regarded to the average values of weight difference per
intervention group, a greater reduction was observed among
participants of the DieTBra group, with an average reduction
of 2.83 ± 5.79 kg, followed by the DieTBra þ EVOO group,
1.69 ± 3.44 kg. Participants in the EVOO group had a weight gain of
about þ1.39 ± 3.2 kg at the end of follow-up. When comparing the
means between two interventions, a statistically significant dif-
ference was found between the EVOO group and the DieTBra
group (p < 0.001). In the other comparisons between two groups
there was no statistically significant difference: EVOO x
DieTBra þ EVOO (p ¼ 0.007); DieTBra x DieTBra þ EVOO
(p ¼ 0.734).
4. Discussion
This was the first clinical trial to evaluate the effectiveness of
extra virgin olive oil and DieTBra in reducing symptoms of anxiety
and depression in individuals with severe obesity. This study pro-
vides important insights, both in the area of psychiatry and psy-
chology and nutrition. There was an expressive reduction of
symptoms in the three intervention groups, demonstrating its
beneficial effects. The interventions tested here can contribute
significantly to the management of anxiety and depression in in-
dividuals with severe obesity. This study shows that nutritional
interventions are a promising field of research in the field of psy-
chiatry and psychology.
The results of this study are consistent with our hypothesis, in
other words, the DieTBra promotes a reduction of symptoms of
depression and anxiety. Similar results were observed in cohort
studies that evaluated the MedDiet [21,36e39]. Another study
that assessed individuals with depression observed that they had
low consumption of fruit, vegetables and low intake of some B
408 A.B.S. Canheta et al. / Clinical Nutrition 40 (2021) 404e411

Table 1
Characterization of the intervention groups according to sociodemographic variables, lifestyle, degree of obesity and regular binge eating.

Total EVOO DieTBra DieTBra þ EVOO p

Sex 0.452a
Female 109 (84.50) 39 (88.64) 34 (79.07) 36 (85.71)
Male 20 (15.50) 5 (11.36) 9 (20.93) 6 (14.29)
Age (years) 0.232b
18-29 17 (13.18) 6 (13.64) 5 (11.63) 6 (14.29)
30-39 47 (36.43) 20 (45.45) 15 (34.88) 12 (28.57)
40-49 48 (37.21) 14 (31.82) 20 (46.51) 14 (33.33)
50 or more 17 (13.18) 4 (9.09) 3 (6.98) 10 (23.81)
Marital Status 0.563a
Lives without a partner 44 (34.11) 14 (31.82) 13 (30.23) 17 (40.48)
Lives with partner 85 (65.89) 30 (68.18) 30 (69.77) 25 (59.52)
Schooling 0.406a
0e8 years of study 42 (32.56) 13 (29.55) 12 (27.91) 17 (40.48)

9 years of study 87 (67.44) 31 (70.45) 31 (72.09) 25 (59.52)
Economic class 0.455a
A/B 30 (23.26) 13 (29.55) 8 (18.60) 9 (21.43)
C/D/E 99 (76.74) 31 (70.45) 35 (81.40) 33 (78.57)
Number of comorbidities 0.142a
4 48 (37.21) 18 (40.91) 11 (25.58) 19 (45.24)
>4 81 (62.79) 26 (59.09) 32 (74.42) 23 (54.76)
Binge drinking 0.948a
No 90 (69.77) 30 (68.18) 30 (69.77) 30 (71.43)
Yes 39 (30.23) 14 (31.82) 13 (30.23) 12 (28.57)
Smoking 0.740b
No 85 (65.89) 29 (65.91) 31 (72.09) 25 (59.52)
Ex-smoker 36 (27.91) 13 (29.55) 10 (23.26) 13 (30.95)
Yes 8 (6.20) 2 (4.55) 2 (4.65) 4 (9.52)
Physical activity 1.000b
Adequate 9 (7.44) 3 (7.32) 3 (7.32) 3 (7.69)
Not adequate 112 (92.56) 38 (92.68) 38 (92.68) 36 (92.31)
Degree of obesity 0.387a
35.0e39.9 kg/m2 22 (17.05) 10 (22.73) 5 (11.63) 7 (16.67)

40.0 kg/m2 107 (82.95) 34 (77.27) 38 (88.37) 35 (83.33)
RBE 0.603a
Without RBE 41 (31.78) 12 (27.27) 12 (37.21) 13 (30.95)
With RBE 88 (68.22) 32 (72.73) 27 (62.79) 29 (69.05)
Anxiety 0.034a
No 38 (29.46) 10 (22.73) 19 (44.19) 9 (21.43)
Yes 91 (70.54) 34 (77.27) 24 (55.81) 33 (78.57)
Depression 0.623a
No 50 (38.76) 15 (34.09) 19 (44.19) 16 (38.10)
Yes 79 (61.24) 29 (65.91) 24 (55.81) 26 (61.90)
Anxiety and Depression 0.247a
No 59 (45.74) 17 (38.64) 24 (55.81) 18 (42.86)
Yes 70 (54.26) 27 (61.36) 19 (44.19) 24 (57.14)

Bold denotes statistical significance.

a
Pearson's chi-square.
b
Fishers exact test. EVOO: extra virgin olive oil. RBE: Regular Binge Eating. DieTBra: Traditional Brazilian diet.

complex vitamins [40]. Thus, previous evidence, but not of clinical
trials, support our findings that healthy diets rich in vegetables
and fruit such as the DieTBra may be effective in the reduction of
depression and anxiety, both with high prevalence in obese
individuals.
The findings of the present study demonstrated the effective-
ness of intervention with olive oil in the reduction of the symptoms
of anxiety, depression and anxiety/depression in severe obese in-
dividuals. These results are in agreement with observational
studies that examined the association between the adherence to
DietMed, in which olive oil is part of the standard diet, and reducing
the risk of depression [17,39,41]. A clinical trial on Major Depression
compared the effects of supplementation with fish oil capsules, rich
in poly-unsaturated fatty acids, with olive oil capsules, rich in
monounsaturated fatty acids, used in this study as placebo, and
reported a reduction in depression symptoms in both groups [42].
Neuroprotective and antioxidant activities from both supplements
can influence mood.

Table 2
Prevalence of symptoms of anxiety and depression at the end of the study according to the intervention group.

EVOO DieTBra DieTBra þ EVOO All groups EVOO x DieTBra EVOO X DieTBra x
(n ¼ 36) (n ¼ 38) (n ¼ 39) DieTBra þ EVOO DieTBra þ EVOO

n (%) n (%) n (%) pa pa pa pa

Anxiety 21 (58.33) 13 (34.21) 22 (56.41) 0.066 0.037 0.866 0.050

Depression 13 (36.11) 12 (31.58) 17 (44.74) 0.485 0.680 0.450 0.238
Anxiety and Depression 11 (30.56) 9 (23.68) 13 (34.21) 0.594 0.506 0.737 0.312
a
Pearson's chi-square. EVOO: extra virgin olive oil. DieTBra: Traditional Brazilian diet.
 A.B.S. Canheta et al. / Clinical Nutrition 40 (2021) 404e411 409

Table 3
Percentage variation in the prevalence of anxiety and depression between the beginning and end of the study in each intervention group.

EVOO

Beginning (n ¼ 44) Final (n ¼ 36) D percentageb 95% CI pa

Anxiety 34 (77.27) 21 (58.33) 38.23 ¡13.86e-68.42 0.019

Depression 29 (65.91) 13 (36.11) 55.17 ¡29.88e-80.25 <0.001
Anxiety and Depression 27 (61.36) 11 (30.56) 57.69 ¡29.88e-80.25 <0.001

DieTBra

Beginning (n ¼ 43) Final (n ¼ 38) D percentualb IC 95% pa

Anxiety 24 (55.81) 13 (34.21) 45.83 ¡16.75e-76.62 0.014

Depression 24 (55.81) 12 (31.58) 50.00 ¡21.09e-78.90 0.007
Anxiety and Depression 19 (44.19) 9 (23.68) 66.67 ¡34.75e-93.32 0.014

DieTBra þ EVOO

Beginning (n ¼ 42) Final (n ¼ 39) D percentualb IC 95% pa

Anxiety 33 (78.57) 22 (56.41) 33.33 ¡10.93e-69.21 0.013

Depression 26 (61.90) 17 (44.74) 34.61 ¡7.48e-70.10 0.035
Anxiety and Depression 24 (57.14) 13 (34.21) 27.78 ¡6.02e-60.97 0.013

Bold denotes statistical significance.

a
McNemar's test. EVOO: extra virgin olive oil. DieTBra: Traditional Brazilian diet.
b
Calculated for individuals who completed the study.

Table 4
Reduction of symptoms of anxiety and depression in three intervention groups according to weight loss at the end of follow-up (n ¼ 113).

Participants who maintained or gained weight (n ¼ 55)

EVOO (n ¼ 27) DieTBra (n ¼ 14) EVOO þ DieTBra (n ¼ 14) All groups EVOO x DieTBra EVOO X DieTBra x
DieTBra þ EVOO DieTBra þ EVOO

n (%) n (%) n (%) pa pa pa pa

Anxiety 5 (18.52) 2 (14.29) 4 (28.57) 0.747 1.000 0.692a 0.648a

Depression 10 (37.04) 2 (14.29) 2 (14.29) 0.210 0.165 0.165a 1.000a
Anxiety and Depression 9 (33.33) 2 (14.29) 4 (28.57) 0.529 0.275 0.501 1.000

Participants who reduced weight (n ¼ 58)

EVOO (n ¼ 9) DieTBra (n ¼ 24) EVOO þ DieTBra (n ¼ 25) All groups EVOO x DieTBra EVOO X DieTBra x
DieTBra þ EVOO DieTBra þ EVOO

n (%) n (%) n (%) pa pa pa pa

Anxiety 3 (33.33) 7 (29.17) 7 (28.00) 1.000 1.000 1.000 1.000

Depression 2 (22.22) 10 (41.67) 7 (29.17) 0.600 0.429 1.000 0.547
Anxiety and Depression 3 (33.33) 7 (29.17) 7 (29.17) 1.000 1.000 1.000 1.000
a
Fisher's exact test. EVOO: extra virgin olive oil. DieTBra: Traditional Brazilian diet.

The PREDMED study did not observe an effect of DieTMed on the
risk of developing depression, even with higher consumption of
olive oil than the present study [43]. This difference between the
present study and the PREDMED study may be due to the difference
in the use of olive oil, and in our study the oil was used only at room
temperature while in PREDMED the oil was used for cooking, which
may have reduced its effects [43]. Another difference is the study
type, i.e. the PREDMED is a cohort study and the DieTBra Trial is a
randomized clinical trial.
Together with other studies that reported an association be-
tween a pro-inflammatory diet and risk of depression [44,45], the
results herein strengthen the idea that diets with healthy profile,
in addition to the health benefits already known, lead to positive
effects on depression symptoms [46]. Although the physiological
mechanisms involved are not completely clear, pro-inflammatory
foods such as those rich in saturated fats may induce the release of
pro-inflammatory cytokines impairing the activity of the dopa-
minergic system, while the intake of monounsaturated fats
improve brain function [47]. The results obtained in this study
endorses data from animal models that verified anxiolytic and
antidepressants effects through repeated administration of olive
oil to rats. Such effects were accompanied by changes in the
monoaminergic system with changes in serotonin and dopamine
levels [48].
The three interventions presented a statistically significant
reduction in the symptoms of anxiety, depression and the
concomitant presence of anxiety and depression. Among partici-
pants who presented the two symptoms, the percentage of
reduction was close to 70.0% in the DieTBra group and almost 60.0%
in the EVOO group. For depression, a reduction around 50.0% was
observed in the EVOO and DieTBra groups. In addition to the sta-
tistical significance, these results have significant clinical relevance
when compared with first-line treatments in the management of
anxiety and depression. A meta-analysis of pharmacological treat-
ment for generalized anxiety found 60.6% of remission of symp-
toms with fluoxetine [49]. A previous study with medication
intervention and cognitive-behavioral psychotherapy reported a
reduction of 46.4% and 46.3%, respectively, in the symptoms of
depression [50]. The advantage of an nutritional intervention is that
it is cheaper, safer, and has no side effects as with drugs. However,
we do not intend to suggest the non-use of medications in the
treatment of these symptoms, since each case should be evaluated
individually by the professionals involved in the treatment; we
reinforce the idea that nutritional treatment, especially the
410 A.B.S. Canheta et al. / Clinical Nutrition 40 (2021) 404e411
treatment used in the present study, has large potential as an
adjuvant therapy in the management of anxiety and depression in
severe obese patients.
In addition to the nutritional intervention in itself, another
factor that changes over a long study and that can influence the
occurrence of the outcomes studied is body weight. Thus, for the
control of this variable, we carried out stratified analysis by loss,
maintenance or gain weight. The difference in body weight did not
influence the results of the reduction of symptoms of depression
and anxiety. A clinical trial in which the intervention was an indi-
vidualized diet with calorie restriction and also used the HADS,
observed that weight loss was associated with the reduction of
depression symptoms, but not with anxiety symptoms of anxiety
[38]. Another clinical trial with dietary intervention in individuals
with metabolic syndrome found an association between weight
loss and reduction of anxiety symptoms [14]. This contrasting re-
sults in relation to the influence of body weight is probably due to
the specificities of the target population of each study, as the other
studies were not developed with individuals with severe obesity.
One limitation of the present study is the time of follow-up,
which could be longer so that we could evaluate the long term
effect of these interventions, but few clinical trials with this type of
intervention have a longer duration. The advantages include the
methodological care adopted in all stages of the study, impacting
the high quality of the data. Another strong point was the low loss
of follow-up (12%), given that this was a clinical trial.
5. Conclusion
Both nutritional interventions, olive oil and DieTBra, were
effective in reducing the symptoms of depression and anxiety in
individuals with severe obesity, alone or in combination. As anxiety
and depression disorders have many causes, it is important to have
interventions with different therapeutic approaches, including
nutritional interventions that showed positive results in this clin-
ical trial. These results contribute to the advancement of knowledge
related to the influence of the dietary pattern on the psychological
health e depression and anxiety. DieTBra and olive oil are prom-
ising interventions for the treatment of symptoms of depression
and anxiety and can be applied on a large scale to deal with these
problems, considering the lack of adverse effects and their relative
ease of inclusion in the dietary routine.
Funding
The present study received partial funding from the Research
Support Foundation of the State of Goia
s (FAPEG) [Grant
201310267000003].
Author contribution
ABSC conceived the study; collected, analyzed and interpreted
data and wrote the manuscript. ASACS collected data and helped
with the statistical analysis and data interpretation. JDS collected
data and helped with the interpretation of the data. EAS conceived
and coordinated the DieTBra Trail, obtained funding, conceived the
research question, collaborated in the interpretation of results and
writing of the manuscript. All authors participated in the design of
research protocols, in the revision and manuscript's final approval.
Conflict of interest
None.
Acknowledgements
We thank the team and coordination of the Clinical Research
Unit of the Hospital das Clínicas of the Federal University of Goi

as
for the support and provision of the physical space for this study,
and the Coordination for the Improvement of Higher Education
Personal (CAPES) Doctoral scholarship to Santos ASAC and Souza JD.
We are also grateful to all those who took part in the study and the
ANOG - Outpatient Clinic of Nutrition in Severe Obesity, mainly the
coordination of this outpatient and PI of this study Dra EA Silveira.
Appendix A. Supplementary data
Supplementary data to this article can be found online at
https://doi.org/10.1016/j.clnu.2020.05.046.
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