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Completed

NCT Number: NCT07471646

Effects of Ramadan Fasting With Exercise on Cardiometabolic Health

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.

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Key information

Conditions

Ramadan Fasting Aerobic Exercise Body Weight Body Weight Changes Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity & Overweight Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Kinesiology

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Total body fat mass

    Time frame: 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 outcomes

  1. Glycemic control

    Time frame: 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 (%).

  2. Lipids profile

    Time frame: 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.

  3. Resting metabolic rate

    Time frame: 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).

  4. Circulating concentrations of interleukin-6 (IL-6)

    Time frame: 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).

  5. Tumor necrosis factor-alpha (TNF-α)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Effects of Ramadan Diurnal Fasting Combined With a Structed Aerobic Exercise on Body Composition and Cardiometabolic Health in Adults With Overweight and Obesity

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 13, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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