Ramadan Fasting, Obesity & Overweight, Aerobic Exercise, Weight Loss
Conditions
Keywords
Ramadan fasting, Body composition, metabolic health, obesity
Brief summary
The goal of this interventional study is to examine the effects of Ramadan diurnal fasting alone and in combination with moderate-intensity aerobic exercise on cardiometabolic health in adults with overweight and obesity. The main questions it aims to answer are: 1. Does Ramadan diurnal fasting lead to changes in body composition and cardiometabolic health outcomes? 2. Does adding moderate-intensity aerobic exercise during Ramadan fasting result in greater improvements in cardiometabolic health compared with fasting alone? Participants will be randomly assigned to one of two groups: Ramadan diurnal fasting only or Ramadan diurnal fasting combined with a supervised moderate-intensity aerobic exercise program. Cardiometabolic, metabolic, and behavioral outcomes will be assessed before Ramadan and during the last week of Ramadan.
Interventions
BEHAVIORALModerate-Intensity Aerobic Exercise
Participants observe Ramadan diurnal fasting, abstaining from food and caloric beverages from dawn to sunset, and engage in a supervised moderate-intensity aerobic exercise program performed approximately five days per week during Ramadan. Exercise sessions are conducted at a target intensity of moderate exertion and are completed while participants are fasting
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
This is an open-label study; no participants, investigators, or outcome assessors are masked due to the nature of the fasting and exercise intervention.
Intervention model description
Participants are randomly assigned to one of two parallel groups: Ramadan diurnal fasting alone or Ramadan diurnal fasting combined with moderate-intensity aerobic exercise. Each participant receives only the intervention assigned to their group, and outcomes are assessed concurrently during the study period
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 20-60 * Body mass index (BMI) ≥27 kg/m² * Planning to observe Ramadan diurnal fasting for the duration of Ramadan
Exclusion criteria
* Diagnosed cardiovascular, metabolic, renal, or endocrine disease (e.g., diabetes, cardiovascular disease) * Use of medications known to affect metabolism, glucose regulation, or lipid metabolism * Current smoking or use of nicotine products * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total body fat mass | From enrollment to the end of the month of Ramadan (week 10) | Total body fat mass in kilogram will be assessed using dual-energy X-ray absorptiometry (DEXA) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | From enrollment to the end of the month of Ramadan (week 10) | Glycemic control will be assessed using a panel of biomarkers representing short-, intermediate-, and long-term glucose regulation. Fasting blood glucose (FBG) will be measured from capillary whole blood samples using the Cholestech LDX® Analyzer (Abbott, USA). Participants will fast for 8-10 hours prior to testing, and glucose concentrations will be reported in (mg/dL). Fructosamine will be measured from blood samples using a commercially available colorimetric assay kit based on the nitroblue tetrazolium (NBT) reduction method. This marker will reflect average glycemic exposure over the preceding 2-3 weeks by quantifying glycated serum proteins, primarily albumin, and will be used to capture short-term changes in glycemic control during the intervention. Glycated hemoglobin (HbA1c) will be measured from whole blood using an automated analyzer manufactured by Abbott. HbA1c values will be reported as percentages (%). |
| Lipids profile | From enrollment until the end of the month of Ramadan (week 10) | The lipid profile will be assessed using whole blood samples analyzed with the Cholestech LDX® Analyzer (Abbott, USA). Whole blood will be obtained via venipuncture following an overnight fast of 8-10 hours. The lipid panel will include total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG). Lipid concentrations will be reported in milligrams per deciliter (mg/dL). LDL-C will be directly measured or calculated by the analyzer in accordance with manufacturer specifications and triglyceride levels. |
| Resting metabolic rate | From enrollment until the end of the month of Ramadan (week 10) | Resting metabolic rate (RMR) will be assessed using indirect calorimetry with a metabolic cart. RMR will be calculated using the Weir equation and will be reported in kilocalories per day (kcal/day). |
| Circulating concentrations of interleukin-6 (IL-6) | From enrollment until the end of the month of Ramadan (week 10) | IL-6 will be quantified using commercially available high-sensitivity ELISA kits based on antibody-specific binding and colorimetric detection. Concentrations will be reported in (pg/mL). |
| Tumor necrosis factor-alpha (TNF-α) | From enrollment until the end of the month of Ramadan (week 10) | TNF-α will be quantified using commercially available high-sensitivity ELISA kits based on antibody-specific binding and colorimetric detection. Concentrations will be reported in (pg/mL) |
Countries
United States
Outcome results
None listed