2. 2 of 8 | FOSHATI et al.
Available evidence from epidemiological and clinical investi-
gations (as reviewed by Jantaratnotai et al) 4
and meta-
analyses 5
suggest an association between psychiatric disorders, including de-
pression and obesity. There is a mutual relationship between obesity
and depression as one augments the risk for developing the other.4
A meta-
analysis of observational studies showed that individuals
with obesity had 32% higher risk of depression.6
Reciprocally, a large
cross-
sectional study revealed that patients with depression had
31% higher risk of general and 26% higher risk of central obesity
than healthy individuals.7
Obesity may be a side effect of antide-
pressants, but it has also been observed in depressive patients who
were not on medications.8
It has been found that depressive patients
may overeat as an unintentional attempt to increase brain serotonin
synthesis and alleviate sadness.9
Obesity brings a wide spectrum
of metabolic and non-
metabolic disorders ranging from hyperten-
sion and dyslipidemia to insulin resistance and increased systemic
inflammation and oxidative stress.10,11
Accordingly, individuals with
obesity have higher rate of morbidity and mortality than healthy
subjects. On the other hand, hypocaloric diets may cause hunger
and exacerbate mood and depression.12
Thus, diet manipulations
other than hypocaloric diets may be better tolerated by patients
with depression.
The beneficial effect of Mediterranean dietary pattern against
obesity and metabolic syndrome has been partly attributed to olive
oil.13
Prospective cohort studies have shown that the risk of devel-
oping obesity is lower in subjects who consume olive oil.14,15
Also,
interventions with olive oil have produced promising results in pa-
tients with genetic susceptibility for obesity.16
Given the putative
benefits of olive oil in the control of weight, we questioned if olive
oil can benefit in weight control of depressive patients. In the cur-
rent study, we examined the effect of olive oil on weight, waist cir-
cumference, and blood lipids in patients with depression. Because
virgin olive oil may also have benefits for reducing inflammation
and oxidation,17
and a link between depression, inflammation, and
oxidative stress has been recognised,18
we also examined the ef-
fect of olive oil on malondialdehyde and high sensitivity-
C reactive
protein (hs-
CRP) as markers of oxidative stress and inflammation,
respectively.
2 | METHODS
2.1 | Study design and participants
The study was a randomised double-
blind controlled trial conducted
in January and February 2016. The sample size was determined 31
in each group to detect a between-
group difference of 1.7 ± 2.4 kg/
m2
with 80% power and 0.05 type 1 error.19
Participants were pa-
tients with major depression,20
aged between 18 and 65 years, and
willing to participate. Patients with other serious mental disorders,
inflammatory diseases such as arthritis, metabolic illnesses, the use
of corticosteroids or medications for the control of blood lipids, fat
malabsorption, allergy to olives, and alcohol or drug addiction were
not included. Exclusion criteria included hospitalisation and with-
drawal of consent.
Patients were recruited via poster announcements, recalls in a
local newspaper, and referrals from psychiatrics. Written informed
consent was obtained from all participants after clarification of
the study goal and procedure. The trial was approved by the Ethics
Committee of the Shiraz University of Medical Sciences (approval
number IR.SUMS.REC.1394.149) and registered in the Iranian
Registry of Clinical Trials (IRCT2016041820140N3).
2.2 | Intervention
Participants were randomly allocated to extra virgin olive oil (EVOO)
and sunflower oil groups (n = 31 each). A computer-
generated ran-
dom sequence with a block size of 4 was used for random alloca-
tion. Randomisation, enrollment, and assignment of patients to the
groups were implemented by research assistants not involved in out-
come assessment. Neither investigators nor participants were aware
of the group assignment up to completion of the trial. To maintain
blindness of the treatments, oils were packed in identical dark bot-
tles without labelling, and the bottles were put in identical paper
packets for delivery. Both oils were nearly odourless and tasteless,
and participants did not notice the type of oil that they consumed as
confirmed by questioning during the intervention.
The intervention period was 52 days, during which partici-
pants consumed 25 mL/day of the corresponding oils. Measuring
cups were given to the participants, and they were asked to eat
oils unheated, for instance, with salad or cooked rice. Isocaloric
diets were prescribed to the patients according to their previous
What's known
• A large number of patients with depression suffer from
overweight or obesity due to a side effect of antidepres-
sants or an unintentional overeating to increase brain
serotonin synthesis and alleviate sadness.
• Olive oil has been introduced as a helpful oil for weight
control efforts in different disease conditions.
• Until now, no study has been investigated the effects of
olive oil in patients with depression.
What’s new
• Extra virgin olive oil remarkably decreased waist circum-
ference in patients with depression without need for ad-
ministration of a low-
calorie diet.
• Extra virgin olive oil relatively increased high-
density li-
poprotein cholesterol in patients with depression.
• Extra virgin olive oil did not show anti-
inflammatory or
anti-
oxidative effects in patients with depression.
3. | 3 of 8
FOSHATI et al.
individual energy intake. To ensure that the addition of the oil does
not increase energy intake, registered dietitians calculated energy
requirements of the participants individually and gave necessary
recommendations to cut down ingestion of oils from other sources.
Instructions were also given to the subjects to follow their habitual
physical activity and sleep pattern. As a monitoring tool, diary sheets
were given to the patients to record their oil intake after each time
of oil consumption. According to these diary sheets, 68.3% of the
patients consumed at least 80% of the recommended oils during the
intervention. Phone calls were made regularly during the interven-
tion in order to remind the participants for oil ingestion, diet, and
other recommendations.
2.3 | Fatty acid composition of the oils
Oils were purchased from Verjen manufacturer, Gorgan, Iran.
The fatty acid composition of the oils was determined by high-
performance liquid chromatography.21
The proportion of satu-
rated, mono-and poly-
unsaturated fatty acids was 17.7%, 65.4%,
and 16.9% in EVOO and 10.5%, 25.2%, 64.3% in sunflower oil,
respectively.
2.4 | Anthropometric measures
Anthropometric indices were the primary outcomes of the trial.
Height was estimated with the precision of 0.5 cm by using a
non-
stretchable tape fixed on a wall. Weight was measured with
minimal clothing to the nearest 0.1 kg using a digital scale (Glamor
BS-
801, Hitachi, China). BMI was calculated by dividing weight in
kilograms by height in square meters. Waist circumference was
measured without pressure to the abdomen at the middle of the
distance between the lowest rib and the iliac crest by using a non-
stretchable tape.
2.5 | Biochemical measures
Blood samples were taken from participants after 12-
h over-
night fasting at pre-and post-
intervention time points. Serum
was immediately separated, frozen, and stored at −80°C until
the time of measurements (<2 months). Triglycerides, total cho-
lesterol (Pars-
Azmun, Iran), low-
density lipoprotein cholesterol,
and high-
density lipoprotein cholesterol (Biotech, Iran) were de-
termined by using commercially available kits and an autoana-
lyser (BT 1500, Biotecnica Instruments, Italy). Very low density
lipoprotein cholesterol was quantified by dividing the triglyceride
value by 5. Malondialdehyde was quantified with the thiobarbi-
turic acid reactive substance method as described previously.22
The level of hs-
CRP was determined by commercially available
kit (IBL International, Germany) according to the manufacturer's
instructions.
2.6 | Dietary intakes and physical activity
Dietary intakes were evaluated by 3-
day diet record (two weekdays
and one weekend day) at the beginning, middle, and the end of the
intervention. Following receipt, food records were checked with the
participants and incomplete records were completed through the
interview (in person or by phone). Nutrient composition was deter-
mined with Nutritionist IV version 3.5.2 (Hearst Corp., San Bruno,
CA). Physical activity was assessed by validated international physi-
cal activity questionnaire (IPAQ) and expressed as metabolic equiva-
lent task in minutes per week (Met-
min/wk).23
2.7 | Statistical analysis
Data were analysed with SPSS software version 19 (SPSS Inc).
Analysis was performed with the intention-
to-
treat approach, for
which data of withdrawn participants were imputed using their base-
line values. Normality of data was checked with Shapiro–
Wilk test,
and abnormally distributed data were log-
transformed before analy-
sis. Baseline values were compared between two groups with inde-
pendent t-
test. For comparison of baseline and post-
intervention
values in each group, paired sample t-
test was used. Between-
group
comparison of the alterations in anthropometric and biochemical
markers was performed using analysis of covariance (ANCOVA) with
age, sex, Beck depression inventory, and corresponding baseline val-
ues as confounders. The average of dietary intakes throughout the
intervention was compared between the groups with independent
t-
test. Statistical significance was set at P < .05.
3 | RESULTS
A total of 248 patients with depression were screened, of which 62
met the inclusion criteria and agreed to participate in the trial. These
were equally divided into the EVOO and sunflower oil groups. In the
middle of the intervention, four patients from EVOO and three from
sunflower oil group withdrew and 55 completed the study. However,
the analysis was performed on all 62 patients according to the
intention-
to-
treat approach. The flowchart of the trial is depicted
in Figure 1.
Demographic and baseline characteristics of the participants
are presented in Table 1. Patients aged between 19 and 65 years,
and 29% were males. Of them, 43.5% had normal BMI and 32.3%
and 24.2% had overweight and obesity, respectively. About half
(48.4%) had abdominal obesity (waist circumference >102 cm
in men and >88 cm in women), 17.7% had serum triglycerides
>150 mg/dL, 22.4% had total cholesterol >200 mg/dL, 12.4% had
high-
density lipoprotein (LDL) cholesterol >130 mg/dL, and 44.8%
had high-
density lipoprotein (HDL) cholesterol (<40 mg/dL in men
and <50 mg/dL in women). There was no significant difference in
any of the demographic or baseline characteristics between the
two groups.
4. 4 of 8 | FOSHATI et al.
Weight and BMI decreased during the intervention in both
groups, the decline in BMI was significant for sunflower oil group
(−2.0 ± 0.53 kg/m2
, P = .047) (Table 2). Waist circumference decreased
significantly in EVOO group (−2.15 ± 2.09 cm, P < .001). Except for
HDL-
C, which increased significantly in EVOO group (3.02 ± 6.79 mg/
dL, P = .03), none of other lipid fractions changed significantly during
the intervention. Similarly, hs-
CRP and malondialdehyde did not sig-
nificantly change. Among these variables, only alteration in waist cir-
cumference was significantly different between the two groups.
Intake of polyunsaturated fatty acids (PUFA) increased follow-
ing consumption of sunflower oil and that of monounsaturated fatty
acids (MUFA) increased after consumption of EVOO (Table 3). Intake
of other macro-and micro-
nutrients was not different between the
groups.
4 | DISCUSSION
Results of this trial showed that consumption of 25-
mL/day EVOO
may decrease waist circumference of patients with depression with-
out affecting their weight, lipid profile, and circulating concentra-
tions of hs-
CRP and malondialdehyde compared to sunflower oil.
4.1 | Weight
Epidemiological studies have documented the reverse relationship
between olive oil consumption and obesity. For instance, in a 6-
year
cohort study, the risk of developing obesity was 2.3 times more in
subjects who used sunflower oil compared to olive oil consumers.14
FI G U R E 1 Flowchart of the trial
TA B LE 1 Baseline characteristics of the participants
Olive oil (n = 31) Sunflower oil (n = 31) P valuea
Age (year) 41.0 ± 11.6 43.3 ± 11.6 0.43
Sex (male) 8 (25.8) 10 (32.3) 0.58
Beck depression inventory 33.3 ± 10.8 31.4 ± 9.3 0.46
Weight (kg) 67.1 ± 14.3 69.9 ± 9.5 0.36
BMI (kg/m2
) 25.6 ± 5.9 26.8 ± 4.4 0.36
Waist circumference (cm) 89.1 ± 13.9 92.9 ± 10.4 0.23
Triglycerides (mg/dL) 101.5 ± 33.5 120.4 ± 53.5 0.12
Total cholesterol (mg/dL) 173.7 ± 42.9 187.8 ± 38.7 0.19
LDL cholesterol (mg/dL) 102.0 ± 32.6 109.6 ± 28.7 0.35
VLDL cholesterol (mg/dL) 20.3 ± 6.7 24.1 ± 10.6 0.11
HDL cholesterol (mg/dL) 47.5 ± 6.8 47.6 ± 5.3 0.95
hs-
C reactive protein (mg/L) 1.97 ± 2.63 2.73 ± 2.83 0.30
Malondialdehyde (μmol/L) 1.18 ± 0.65 1.30 ± 0.62 0.48
Note: Data are expressed as mean ± SD or n (%) (for sex).
Abbreviations: BMI, body mass index; HDL, high-
density lipoprotein; LDL, low-
density lipoprotein; VLDL, ver low density lipoprotein.
a
Between-
group difference was examined by independent t-
test for quantitative data or chi-
square for sex.
5. | 5 of 8
FOSHATI et al.
Likewise, a 28-
month cohort indicated that the likelihood of weight
gain was less in participants in the upper quintile of olive oil con-
sumption (~46 g/day) compared with those in the lowest quintile
(~6 g/day).15
However, interventions with olive oil have not con-
firmed these cohort studies. For instance, no effect on body weight
was observed in patients with non-
alcoholic fatty liver disease fol-
lowing consumption of EVOO,24
in patients with type 2 diabetes
and non-
diabetic obese patients who took MUFA-
enriched diet,25
overweight women consuming EVOO,26
or in individuals with risk
factors of cardiovascular disease who used Mediterranean diet sup-
plemented with EVOO for 5 years.27
In agreement with these re-
ports, we did not observe a significant effect from EVOO on weight
and BMI of participants in this study. A part of the lack of effect may
have been due to favourable effect of sunflower oil used in the con-
trol group. In contrast to negative results from this and similar stud-
ies, a 3-
year intervention with Mediterranean diet supplemented
with virgin olive oil showed that virgin olive oil reduced weight of
subjects with a polymorphism for adiposity,16
suggesting that olive
oil may be more effective in individuals with a genetic susceptibility
to obesity.
Without imposing energy restriction, both groups showed re-
duction in weight and BMI. This reduction could be due to high lev-
els of PUFA in sunflower oil and MUFA in EVOO. Unsaturated fatty
acids are less obesogenic than saturated fats (SFA) due to mecha-
nisms such as increased diet-
induced thermogenesis and fat oxida-
tion.28
This indicates that participants have likely used quantities of
SFA prior to the intervention.
4.2 | Waist circumference
Despite the lack of effect on weight, a significant decrease was ob-
served in waist circumference of EVOO consumers, causing a sig-
nificant between-
group difference. This suggests that EVOO may
have a specific influence on adipose tissue of abdominal area. MUFA
which are plenty in olive oil are known to be more metabolically ac-
tive than PUFA and are less likely to be stored in adipose tissue.28,29
Oleic acid which comprises ~70% of the fatty acids in olive oil is a
MUFA. It is the product and also an inhibitor of stearoyl CoA desatu-
rase 1, the enzyme responsible for synthesis of MUFA from SFA.30
Experiments on mutagenic animals have proposed a pivotal role for
this enzyme in developing obesity through inhibition of β-oxidation
of fatty acids in the liver and adipose tissue.30
Interestingly, mecha-
nisms of anti-
obesogenic effect of MUFA occur more efficiently in
individuals with obesity 31
and high waist circumference,32
suggest-
ing that MUFA may distinctly affect extra fat mass particularly in
visceral areas.33
In agreement, our previous work on non-
alcoholic
fatty liver patients showed that olive oil may decrease body fat per-
centage compared to sunflower oil.34
Although EVOO did not improve weight, but the reduction in
waist circumference indicates that EVOO may alleviate central
obesity. Because waist circumference has a strong association with
metabolic risk,35
the reduction in waist circumference may come
TA
B
L
E
2
Comparison
of
the
changes
in
the
study
outcomes
within
and
between
the
groups
Olive
oil
(n
=
31)
P
value
a
Sunflower
oil
(n
=
31)
P
value
a
P
value
a
Before
After
Δ
Before
After
Δ
Weight
(kg)
67.1
±
14.3
66.7
±
14.6
−0.39
±
1.30
0.10
69.9
±
9.5
69.4
±
9.4
−0.48
±
1.40
0.06
0.65
BMI
(kg/m
2
)
25.6
±
5.9
25.5
±
6.0
−0.16
±
0.49
0.09
26.8
±
4.3
26.6
±
4.1
−0.20
±
0.53
0.047
0.61
Waist
circumference
(cm)
89.1
±
13.9
87.0
±
13.4
−2.15
±
2.09
<0.001
92.9
±
10.4
92.7
±
10.6
−0.20
±
1.78
0.53
<0.001
Triglycerides
(mg/dL)
101.5
±
33.5
94.7
±
23.3
−6.86
±
29.2
0.23
120.4
±
53.5
112.4
±
46.0
−7.94
±
27.7
0.13
0.38
Total
cholesterol
(mg/dL)
173.7
±
42.9
176.4
±
41.2
2.64
±
23.8
0.56
187.8
±
38.7
179.5
±
43.1
−8.39
±
22.5
0.051
0.13
LDL
cholesterol
(mg/dL)
102.0
±
32.6
101.8
±
28.6
−0.21
±
17.3
0.95
109.6
±
28.7
105.2
±
33.1
−4.45
±
17.8
0.18
0.44
VLDL
cholesterol
(mg/dL)
20.3
±
6.7
18.9
±
4.6
−1.36
±
5.86
0.23
24.1
±
10.6
22.6
±
9.2
−1.52
±
5.55
0.15
0.36
HDL
cholesterol
(mg/dL)
47.5
±
6.8
50.5
±
9.2
3.02
±
6.79
0.03
47.6
±
5.3
47.9
±
6.0
0.36
±
6.34
0.76
0.10
hs-
C
reactive
protein
(mg/L)
1.97
±
2.63
1.69
±
1.86
−0.28
±
2.14
0.50
2.73
±
2.83
2.32
±
2.45
−0.41
±
2.71
0.42
0.72
Malondialdehyde
(μmol/L)
1.18
±
0.65
2.61
±
4.64
1.43
±
4.66
0.12
1.30
±
0.62
3.17
±
5.70
1.88
±
5.66
0.09
0.75
Note:
Data
are
expressed
as
mean
±
SD.
Abbreviations:
BMI,
body
mass
index;
HDL,
high-
d
ensity
lipoprotein;
LDL,
low-
d
ensity
lipoprotein;
VLDL,
very
low
density
lipoprotein.
a
The
difference
between
pre-
and
post-
i
ntervention
values
of
each
group
was
examined
by
paired
t-
t
est
and
that
for
alterations
between
groups
was
examined
by
ANCOVA
using
age,
sex,
Beck
depression
inventory,
and
baseline
values
of
the
corresponding
variable
as
covariates.
6. 6 of 8 | FOSHATI et al.
along with a decrease in the risk of metabolic diseases such as car-
diovascular disease which occurs with higher frequency in patients
with depression.3
In a population-
based study on people with type
2 diabetes, depression was associated with cardiovascular disease
and abdominal obesity.36
Accordingly, gene studies have detected
24 genes implicated in both cardiometabolic disease and mood
disorders.37
Moreover, a systematic review on prospective studies
found that temporal association from obesity-
to-
depression was
stronger than that from depression to obesity.38
These evidences
suggest that correction of obesity and abdominal obesity may help
in amelioration of depression. Clinical trials have shown that correc-
tion of obesity improves mood and cardiovascular risk better than
behavioural psychotherapy.39
4.3 | Lipid profile
Except HDL cholesterol in the EVOO group, other lipids did not
change in any group. Previous trials have reported benefits of
the substitution of MUFA40,41
or PUFA42
for SFA on blood lipids.
However, results of meta-
analyses are conflicting in this regard, with
some meta-
analyses finding no benefit for replacement of SFA with
unsaturated fats on blood lipids43
and some reporting benefits.44
The lack of EVOO effect on blood lipids could be, in one side, due to
beneficial effect of sunflower oil but also because of normal levels
of blood lipoproteins except HDL cholesterol in most of the partici-
pants. In contrast to other lipids, HDL cholesterol demonstrated a
significant improvement in EVOO group, which was likely because
about half of the patients had low levels of HDL. Cross-
sectional45
and clinical trials46
have been in line with the inverse association be-
tween olive oil consumption and HDL cholesterol. HDL may increase
through the competition between olive oil chylomicron remnants
and HDL for reaction with hepatic lipase, thus preventing postpran-
dial decrease in HDL cholesterol.47
Moreover, polyphenols in EVOO
can incorporate into HDL particles and subsequently increase HDL
size, promote HDL stability, and improve antioxidant potential of
HDL particles.48
EVOO has also shown to increase apo A1, the major
lipoprotein of HDL particle which has antioxidant activity and may
prevent LDL oxidation.49
4.4 | hs-
CRP and malondialdehyde
The association of depression with inflammation50
and oxidative
stress51
has been recognised. However, these conditions may be
more evident in depressive patients with predisposing conditions
such as obesity.52
Despite alterations in hs-
CRP and malondialde-
hyde, neither group demonstrated significant change in these mark-
ers in the current study. We assume that the lack of the effect has
been due to benign, if at all any, inflammatory and oxidative condi-
tion in our participants.
4.5 | Limitations
This was the first study examining the effect of EVOO in the ab-
sence of a hypocaloric diet on weight and waist circumference of
patients with depression. However, due to technical limitations, we
could not examine the effect of EVOO and sunflower oil on body fat
mass. Body composition data could help in better interpretation of
weight and waist circumference results. In addition, we assume that
the oils could show better effect on blood lipids and inflammatory
and oxidative markers if participants had abnormal levels of these
parameters. As always, low sample size was a limitation and a conse-
quence of financial constraints.
5 | CONCLUSION
The overall results presented herein showed that consumption of
EVOO may decrease waist circumference of patients with depres-
sion in comparison to sunflower oil. Although no significant between-
group difference was observed in weight and BMI, BMI significantly
decreased in sunflower oil group, suggesting that at least in patients
with depression, sunflower oil (as the source of PUFA) may have
a beneficial effect on weight. Due to causing hunger, hypocaloric
regimens may induce psychological pressure that can be deleteri-
ous for patients with depression. Thus, both EVOO and sunflower
oil would benefit overweight patients with depression because they
may respectively decrease waist circumference and BMI without
need for administration of a low-
calorie diet. In addition, it seems
that consumption of EVOO can increase HDL cholesterol in patients
TA B LE 3 Dietary intakes of the participants during the
intervention
Olive oil
(n = 31)
Sunflower oil
(n = 31) P valuea
Energy (kcal/d) 1536 ± 510.3 1614 ± 533.2 0.62
Carbohydrate
(g/d)
214.6 ± 77.7 237.5 ± 75.3 0.34
Protein (g/d) 49.9 ± 17.8 52.1 ± 22.1 0.67
Total fat (g/d) 54.4 ± 21.3 54.3 ± 27.0 0.98
Saturated fat (g/d) 12.6 ± 6.9 11.2 ± 5.9 0.41
Polyunsaturated
fat (g/d)
12.5 ± 4.6 21.2 ± 7.7 <0.001
Monounsaturated
fat (g/d)
24.6 ± 12.9 14.3 ± 7.4 0.001
Cholesterol (g/d) 168.4 ± 122.3 177.8 ± 133.8 0.76
Fibre (g/d) 14.3 ± 5.8 15.3 ± 6.0 0.53
Sodium (mg/d) 1154 ± 679.4 1049 ± 676.8 0.55
Potassium (mg/d) 1936 ± 751.0 1972 ± 569.7 0.80
Physical activity
(Met-
min/week)
438.6 ± 389.3 492.3 ± 452.0 0.64
Note: Data are expressed as mean ± standard deviation (SD).
a
Between-
group difference was examined by independent t-
test.
7. | 7 of 8
FOSHATI et al.
with depression but may leave other blood lipids and biomarkers of
oxidative stress and inflammation unchanged.
6 | DOSCLUSURE
The authors had no conflict of interest to declare.
ACKNOWLEDGEMENTS
We appreciate the patients who kindly participated in this study.
AUTHOR CONTRIBUTIONS
SF and MA contributed to the conception and design of the study. SF
and AG collected the data, and SF and MA performed data analysis.
SF and MA drafted, and AG edited the manuscript. All the authors
approved the final version of the manuscript.
ETHICAL STATEMENT
The trial was approved by the Ethics Committee of the Shiraz
University of Medical Sciences (approval number IR.SUMS.
REC.1394.149) and registered in the Iranian Registry of Clinical Trials
(IRCT2016041820140N3).
ORCID
Sahar Foshati https://orcid.org/0000-0002-2669-670X
Masoumeh Akhlaghi https://orcid.org/0000-0003-3868-0227
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How to cite this article: Foshati S, Ghanizadeh A, Akhlaghi M.
The effect of extra virgin olive oil on anthropometric indices,
lipid profile, and markers of oxidative stress and inflammation
in patients with depression, a double-
blind randomised
controlled trial. Int J Clin Pract. 2021;00:e14254. https://doi.
org/10.1111/ijcp.14254