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IRCT20231004059615N6 IRCT 2025-09-15 INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY The effect of fasting and resistance training on sarcopenia in postmenopausal women with obesity Effect of long-term intermittent fasting, with or without resistance training, on muscle mass, bone mineral density and biochemical measurements in postmenopausal women with obesity: a randomized clinical trial 2025-09-20 anticipated 120 Complete https://irct.ir/trial/86037 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The names of the subjects will be entered in an Excel column. Using the RAND function (=RAND()), each subject will be randomly assigned a number. Then, the numbers will be sorted from smallest to largest. After that, every 40 subjects will be assigned to one of the study groups (numbers 1 to 40 to the first group, numbers 41 to 80 to the second group, and numbers 81 to 120 to the third group). 3 Obesity. Intervention 1: Intervention group 1: Daily intermittent fasting (16:8, from 19 to 11 h); these volunteers will also receive daily supplementation with whey and casein proteins, calcium, and vitamin D (the amounts will be determined by a nutritional specialist based on the daily needs of each subject). Intervention 2: Intervention group 2: Daily intermittent fasting (16:8, from 19 to 11 h) with resistance training (~1 h, 16 to 17 h, 5 days/week); these volunteers will also receive daily supplementation with whey and casein proteins, calcium, and vitamin D (the amounts will be determined by a nutritional specialist based on the daily needs of each subject). Intervention 3: Control group: Without nutritional and/or exercise intervention. Yes - There is a plan to make this available What will be shared: All data collected during the study will be shareable after de-identifying the subjects. When: The data will be published after the extracted articles are accepted. To whom: All people Conditions: All data collected during the study will be shareable after de-identifying the subjects. The requester will only be permitted to use the data for meta-analysis reviews. Where to obtain: Corresponding author: Davar Khodadadi, Faculty of Physical Education and Sports Sciences, Islamic Azad University Central Tehran Branch, Tehran, Iran Email: davar.khodadadi@yahoo.com How to obtain: Sending an email request to the corresponding author: Davar Khodadadi Email: davar.khodadadi@yahoo.com Comments:
public Davar Khodadadi
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
Tehran Iran (Islamic Republic of) 1955847781 +98 21 2263 3583 davar.khodadadi@yahoo.com Islamic Azad University scientific Davar Khodadadi
Faculty of Physical Education and Sports Sciences, Velayat University Complex, Shahid Sohani St., Sohank
Tehran Iran (Islamic Republic of) 1955847781 +98 21 2263 3583 davar.khodadadi@yahoo.com Islamic Azad University Turkey Female Age > 50 years Body mass index > 30 kg/m2 > 3 years after the final period Not engaged in regular exercise activities over the last six months No smoking or alcohol consumption 50 years 65 years Female Suffering from chronic cardiovascular, liver and kidney diseases Having any pain or mobility limitations that prevent interventions. Current treatment with medication or supplements that significantly affect the main study variables. Having a history of bariatric surgery Following a special diet, including strict vegetarian/vegan, within the past 6 months E66 Overweight and obesity Lifestyle Lifestyle Lifestyle Intervention group 1: Daily intermittent fasting (16:8, from 19 to 11 h); these volunteers will also receive daily supplementation with whey and casein proteins, calcium, and vitamin D (the amounts will be determined by a nutritional specialist based on the daily needs of each subject). Intervention group 2: Daily intermittent fasting (16:8, from 19 to 11 h) with resistance training (~1 h, 16 to 17 h, 5 days/week); these volunteers will also receive daily supplementation with whey and casein proteins, calcium, and vitamin D (the amounts will be determined by a nutritional specialist based on the daily needs of each subject). Control group: Without nutritional and/or exercise intervention Muscle mass. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: By Dual-Energy X-ray Absorptiometry (DXA). Bone mineral density. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: By Dual-Energy X-ray Absorptiometry (DXA). Body weight. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: By digital scale. Body fat, visceral adipose tissue. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: By Dual-Energy X-ray Absorptiometry (DXA). Muscle strength. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using one repetition maximum test and digital strength measuring devices. Balance. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using the dynamic balance test. Resting metabolic rate. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Indirect calorimetry. Cognitive function. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using functional tests to assess executive function, memory, processing speed, and attention. Mood. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using the Menopause-Specific Quality of Life Questionnaire, Patient Health Questionnaire-9, and Generalized Anxiety Disorder-7 questionnaire. Plasma levels of irisin. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Insulin resistance. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using fasting glucose, HOMA-IR, and HbA1c measurements. Lipid profile. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using cholesterol, triglycerides, HDL-C, and LDL-C measurements. Plasma levels of brain-derived neurotrophic factor. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of beta-hydroxybutyrate. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Oxidative stress. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Inflammation. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of hormones. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Meteorin-like protein (Metrnl). Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of dehydroepiandrosterone-sulfate (DHEA-S). Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of FGF-21. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of sclerostin. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of C-terminal telopeptide (CTX). Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of Procollagen Type I N-Terminal Propeptide (P1NP). Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. Plasma levels of fat browning factors. Timepoint: At baseline, and after 2-, 4-, and 6-month intervention as well as following 6-month follow-up. Method of measurement: Using ELISA method. INTERNATIONAL SCIENCE AND TECHNOLOGY UNIVERSITY Approved 2025-09-03 Ethics Committee of the International Science and Technology University Tunahan Mah. Dumlupinar 30 Agustos Cad. No:2, Metromal Business F Blok Office Ankara Ankara Turkey