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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ramadan diurnal fasting only group (RDF) | No Intervention | Participants observe Ramadan diurnal fasting without a structured exercise program. | |
| Ramadan Fasting + Exercise | Experimental | Participants observe Ramadan diurnal fasting and participate in a supervised moderate-intensity aerobic exercise program performed approximately 5 days per week during the fasting period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moderate-Intensity Aerobic Exercise | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total body fat mass | Total body fat mass in kilogram will be assessed using dual-energy X-ray absorptiometry (DEXA) | From enrollment to the end of the month of Ramadan (week 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic control | 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 (%). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan School of Kinesiology | Ann Arbor | Michigan | 48109 | United States |
Individual participant data will not be shared publicly. De-identified, aggregate results will be reported in publications and presentations.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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
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This is an open-label study; no participants, investigators, or outcome assessors are masked due to the nature of the fasting and exercise intervention.
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| From enrollment to the end of the month of Ramadan (week 10) |
| Lipids profile | 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. | From enrollment until the end of the month of Ramadan (week 10) |
| Resting metabolic rate | 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). | From enrollment until the end of the month of Ramadan (week 10) |
| Circulating concentrations of interleukin-6 (IL-6) | 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). | From enrollment until the end of the month of Ramadan (week 10) |
| Tumor necrosis factor-alpha (TNF-α) | 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) | From enrollment until the end of the month of Ramadan (week 10) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |