Obesity & OverweightNCT07873762
Effects of a 12-Week Individualized Energy-Restricted Diet on Perceived Stress and Serum Cortisol in Adults With Overweight or Obesity
A study testing Energy-Restricted Mediterranean-Style Diet in people with Obesity & Overweight, run by Acibadem University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 49 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Energy-Restricted Mediterranean-Style Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2020to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-49 years
- Body mass index (BMI) ≥25 kg/m²
- Seeking weight loss and willing to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perceived Stress, Sleep Quality, and Serum Cortisol During a Twelve-Week Individualized Energy-Restricted Diet in Adults With Overweight or Obesity: A Single-Arm Prospective Study
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.
- Conditions
- Obesity & Overweight
- Being tested
- Energy-Restricted Mediterranean-Style Diet
- Keywords
- weight management, perceived stress, cortisol, obesity, sleep quality, energy-restricted diet, body composition
- Medical subject headings
- Obesity, Overweight, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy-Restricted Mediterranean-Style DietOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Energy-Restricted Diet | Experimental | 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. Receives: Other: Energy-Restricted Mediterranean-Style Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
Secondary outcomes (5)
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).
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
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).
Measured: Baseline and Week 12
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).
Measured: Baseline and Week 12
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.
Measured: Baseline and Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study start1 Jul 2020
- Primary completion1 Oct 2022
- Study completion1 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deniz Tigli Torun, PhD, Principal investigator, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07873762
- Sponsor's protocol ID
- 2019-14/22
- Status last verified
- Oct 2026
- First submitted
- 8 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceived Stress, Sleep Quality, and Serum Cortisol During a Twelve-Week Individualized Energy-Restricted Diet in Adults With Overweight or Obesity: A Single-Arm Prospective Study
- ClinicalTrials.gov ID
- NCT07873762
- Acronym / sponsor ID
- 2019-14/22
- Conditions
- Obesity & Overweight
- Keywords
- weight management, perceived stress, cortisol, obesity, sleep quality, energy-restricted diet, body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 Oct 2022 (actual)
- First posted
- 14 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Energy-Restricted Diet | Experimental | Other: Energy-Restricted Mediterranean-Style DietParticipants 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. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-49 years
- Body mass index (BMI) ≥25 kg/m²
- Seeking weight loss and willing to participate in the study
Key exclusion criteria (7 listed)
- Pregnancy
- Menopause
- Any diagnosed metabolic disease
- Use of psychiatric medication
- Regular alcohol consumption (>2 drinks/day or >9 drinks/week)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Energy-Restricted Mediterranean-Style DietParticipants 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. | Other | Energy-Restricted Diet |
Primary outcome
Change in Serum Cortisol Level
Time frame: Baseline and Week 12
Change in morning serum cortisol concentration from baseline to the end of the 12-week dietary intervention. Serum cortisol was measured in µg/dL.
Change in Perceived Stress Score (PSS-14)
Time frame: Baseline and Week 12
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.
5 secondary outcomes
Change in Body Weight
Time frame: Baseline and Week 12
Change in Body Mass Index
Time frame: Baseline and Week 12
Change in Waist Circumference
Time frame: Baseline and Week 12
Change in Fat Mass
Time frame: Baseline and Week 12
Change in Body Fat Percentage
Time frame: Baseline and Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deniz Tigli Torun, PhD principal investigator
Acibadem University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Energy-Restricted Mediterranean-Style Diet in people with Obesity & Overweight, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Serum Cortisol Level (time frame: Baseline and Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.