- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471646
Effects of Ramadan Fasting With Exercise on Cardiometabolic Health
Effects of Ramadan Diurnal Fasting Combined With a Structed Aerobic Exercise on Body Composition and Cardiometabolic Health in Adults With Overweight and Obesity
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:
- Does Ramadan diurnal fasting lead to changes in body composition and cardiometabolic health outcomes?
- 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan School of Kinesiology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Ramadan diurnal fasting only group (RDF)
Participants observe Ramadan diurnal fasting without a structured exercise program.
|
|
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Experimental: Ramadan Fasting + Exercise
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.
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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From enrollment to the end of the month of Ramadan (week 10)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 (%).
|
From enrollment to the end of the month of Ramadan (week 10)
|
|
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.
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From enrollment until the end of the month of Ramadan (week 10)
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Resting metabolic rate
Time Frame: From enrollment until the end of the month of Ramadan (week 10)
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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)
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).
|
From enrollment until the end of the month of Ramadan (week 10)
|
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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)
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From enrollment until the end of the month of Ramadan (week 10)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00247761
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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