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CompletedNCT07873762Updated Oct 14, 2026

Effects of a 12-Week Individualized Energy-Restricted Diet on Perceived Stress and Serum Cortisol in Adults With Overweight or Obesity

An interventional study of Energy-Restricted Mediterranean-Style Diet in Obesity & Overweight, sponsored by Acibadem University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 49 Years. Per ClinicalTrials.gov, last updated 2026-10-14.

Sponsored by Acibadem University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 6 years 3 months after the study started (first participant enrolled Jul 2020, registered Oct 2026).
Updated Oct 14, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 49 Years
Sex
All
01

Study summary

This prospective interventional study investigated changes in perceived stress, serum cortisol concentrations, body weight, and body composition during a 12-week individualized energy-restricted dietary intervention in adults with overweight or obesity. Participants followed an individually prescribed Mediterranean-style energy-restricted diet and attended weekly follow-up visits throughout the intervention. Body weight and body composition were assessed at weekly follow-up visits, while perceived stress and biochemical parameters, including serum cortisol, were evaluated at baseline and at the end of the 12-week intervention. Sleep quality and physical activity were also assessed at baseline. The study further examined whether perceived stress, serum cortisol, sleep quality, and physical activity were associated with the magnitude of body weight and fat mass loss achieved during the dietary intervention.

02

Conditions studied

  • Obesity & Overweight

Keywords

  • weight management
  • perceived stress
  • cortisol
  • obesity
  • sleep quality
  • energy-restricted diet
  • body composition
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's enrollment of 30 is below the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Acibadem University is the lead sponsor of 218 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adults aged 18-49 years
  • Body mass index (BMI) ≥25 kg/m²
  • Seeking weight loss and willing to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Pregnancy
  • Menopause
  • Any diagnosed metabolic disease
  • Use of psychiatric medication
  • Regular alcohol consumption (>2 drinks/day or >9 drinks/week)
  • Current smoking
  • Habitual vigorous physical activity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Energy-Restricted Diet

    Participants followed a 12-week individualized energy-restricted Mediterranean-style diet. Energy requirements were calculated individually, with 45-55% of total energy from carbohydrates, 15-20% from protein, and 25-30% from fat. Participants attended weekly follow-up visits for body composition assessment, evaluation of dietary adherence, and adjustment of the meal plan.

    Other: Energy-Restricted Mediterranean-Style Diet

Interventions

  • OtherEnergy-Restricted Mediterranean-Style Diet

    Participants followed an individually planned energy-restricted Mediterranean-style diet for 12 weeks. Energy requirements were calculated individually. The prescribed macronutrient distribution was 45-55% of total energy from carbohydrates, 15-20% from protein, and 25-30% from fat. The diet consisted of two to three main meals and two to three snacks per day, with meal distribution adapted to each participant's daily routine. Participants attended weekly follow-up visits, during which adherence was assessed and the dietary plan was adjusted as needed.

06

What researchers measure

Primary outcomes

  1. Change in Serum Cortisol Level

    Change in morning serum cortisol concentration from baseline to the end of the 12-week dietary intervention. Serum cortisol was measured in µg/dL.

    Time frame: Baseline and Week 12

  2. Change in Perceived Stress Score (PSS-14)

    Change in perceived stress from baseline to the end of the 12-week dietary intervention, assessed using the 14-item Perceived Stress Scale (PSS-14). Total scores range from 0 to 56, with higher scores indicating higher perceived stress.

    Time frame: Baseline and Week 12

Secondary outcomes

  1. Change in Body Weight

    Change in body weight from baseline to the end of the 12-week dietary intervention. Body weight was measured in kilograms (kg).

    Time frame: Baseline and Week 12

  2. Change in Body Mass Index

    Change in body mass index (BMI) from baseline to the end of the 12-week dietary intervention. BMI was expressed as kg/m².

    Time frame: Baseline and Week 12

  3. Change in Waist Circumference

    Change in waist circumference from baseline to the end of the 12-week dietary intervention. Waist circumference was measured in centimeters (cm).

    Time frame: Baseline and Week 12

  4. Change in Fat Mass

    Change in fat mass from baseline to the end of the 12-week dietary intervention. Fat mass was assessed by bioelectrical impedance analysis and expressed in kilograms (kg).

    Time frame: Baseline and Week 12

  5. Change in Body Fat Percentage

    Change in body fat percentage from baseline to the end of the 12-week dietary intervention, assessed by bioelectrical impedance analysis.

    Time frame: Baseline and Week 12

07

Study locations

1 site
  • Samsun FBM tıp merkezi
    Samsun, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Oct 2022, 27 months.

Of 2,253 non-industry interventional studies with no phase under Obesity, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 50. This study's 27 months is close to that.

Counting every sponsor, half of 2,351 studies reached it within 26 months; a quarter within 11 and three quarters within 48.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 8, 2026
First posted
Oct 14, 2026
StartActual
Jul 1, 2020
Primary completionActual
Oct 1, 2022
CompletionActual
Oct 1, 2022
Last update
Oct 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 14, 2026
Show all 1 update
  1. Oct 14, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07873762
Responsible party
Sponsor
First posted
Oct 14, 2026
Start date
Jul 1, 2020
Primary completion
Oct 1, 2022
Completion
Oct 1, 2022
Last update
Oct 14, 2026

Study contacts

Deniz Tigli Torun, PhD
principal investigator · Acibadem University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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