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Investigating the effect of low-calorie diets on anthropometric, depression and metabolic parameters in patients with chronic depression and obesity

Investigating the effect of intermittent fasting with and without calorie restriction compared to calorie restriction diet on anthropometric parameters, depression score and metabolic factors in patients with chronic depression and obesity

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20241029063543N1
Enrollment
90
Registered
2024-11-26
Start date
2024-12-29
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Moderate major depressive disorder. Condition 2: Severe Major depressive disorder. Major depressive disorder, recurrent, moderate Major depressive disorder, recurrent severe without psychotic features

Interventions

Intervention 1: Intervention group: Recipient of the intermittent fasting regimen with an 8-hour time limit for food intake (a fixed 8-hour time period chosen by the patient). Patients in the first gr

Sponsors

Tabriz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Patients with chronic depression based on DSM-5 criteria; Diagnostic and statistical manual of mental disorders, fifth edition Age 18 to 75 years Body mass index (weight in kilograms divided by the square of height in meters) between 30 and 40 Score higher than 17 (moderate and severe depression) on a seventeen-item scale Hamilton Depression Rating Scale (HDRS) Having a stable antidepressant treatment regimen for = 6 months before the study Willingness to participate in the study

Exclusion criteria

Exclusion criteria: A history of following special diets or using synthetic/herbal drugs for weight loss during the past three months and as well as Suffering from other major psychiatric/nervous diseases including psychosis, bipolar disorder, multiple sclerosis or epilepsy, thyroid diseases, acute or chronic viral hepatitis, malignant tumors, diabetes, serious liver dysfunction or chronic kidney disease, cardiovascular diseases and Gastrointestinal diseases Having eating disorders pregnancy and breastfeeding Current smoking or drug use Taking nutritional supplements (vitamins and minerals)

Design outcomes

Primary

MeasureTime frame
Anthropometric parameters including weight, height, body mass index, body fat percentage and muscles. Timepoint: Before starting the intervention and then once a month for 6 months. Method of measurement: Anthropometric parameters including weight, height, body mass index, fat percentage and body muscles will be measured using an Omron scale. Weight with light clothes and with accuracy of 100 grams and height without shoes and while the shoulders are in a normal position using a tape measure in a standing and straight position by a ruler that will be placed on the person's head, with an accuracy of 0.5 Centimeters will be measured.;Depression score. Timepoint: Before starting the intervention and then once a month for 6 months. Method of measurement: Hamilton Depression and Beck Questionnaires.;Circadian rhythm. Timepoint: Before starting the intervention and then once a month for 6 months. Method of measurement: Circadian questionnaire.

Secondary

MeasureTime frame
Blood pressure. Timepoint: Before starting the intervention and then once a month for 6 months. Method of measurement: Barometer.;Metabolic factors include lipid profile and fasting blood sugar, serum insulin, hemoglobin A1C, insulin resistance and sensitivity. Timepoint: Before the start of the intervention and at the end of the intervention. Method of measurement: Biochemical tests with ELISA and calorimetric methods.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactLeila Maghsoumi-Norouzabad

Tabriz University of Medical Sciences

l.maghsumi55@gmail.com+98 914 185 9288

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 28, 2026