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
Sponsor study identifier
interventional
30
1 country
1
Study Start
July 1, 2020
Actual (reported)Primary Completion
October 1, 2022
Actual (reported)Study Completion
October 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 1, 2022
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2020
Actual (reported)October 1, 2022
Actual (reported)October 1, 2022
Actual (reported)October 8, 2026
Actual (reported)October 14, 2026
Actual (reported)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.
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.
Baseline and Week 12
Change in Body Weight
Baseline and Week 12
Change in Body Mass Index
Baseline and Week 12
Change in Waist Circumference
Baseline and Week 12
Change in Fat Mass
Baseline and Week 12
Change in Body Fat Percentage
Baseline and Week 12
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Samsun FBM tıp merkezi
Samsun, Turkey (Türkiye)
Deniz Tigli Torun, PhD
Acibadem University
30 participants (actual enrollment reported by the registry).
First Submitted
October 8, 2026
First Posted
October 14, 2026
Study Start
July 1, 2020
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
October 1, 2022
Actual (reported)Study Completion
October 1, 2022
Actual (reported)Last Updated
October 14, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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