Ramadan FastingNCT07471646
Effects of Ramadan Fasting With Exercise on Cardiometabolic Health
A study testing Moderate-Intensity Aerobic Exercise in people with Ramadan Fasting and Obesity & Overweight, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Ramadan Fasting, Obesity & Overweight, Aerobic Exercise
- What is being tested?
- Moderate-Intensity Aerobic Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2026to 1 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 20-60
- Body mass index (BMI) ≥27 kg/m²
- Planning to observe Ramadan diurnal fasting for the duration of Ramadan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan School of Kinesiology
Ann Arbor, Michigan, 48109
About this study
Official title: 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.
- Conditions
- Ramadan Fasting, Obesity & Overweight, Aerobic Exercise, Weight Loss
- Being tested
- Moderate-Intensity Aerobic Exercise
- Keywords
- Ramadan fasting, Body composition, metabolic health, obesity
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moderate-Intensity Aerobic ExerciseBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Moderate-Intensity Aerobic Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total body fat mass
Total body fat mass in kilogram will be assessed using dual-energy X-ray absorptiometry (DEXA)
Measured: From enrollment to the end of the month of Ramadan (week 10)
Secondary outcomes (5)
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 (%).
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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)
Measured: From enrollment until the end of the month of Ramadan (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start1 May 2026
- Primary completion1 May 2026
- Study completion1 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ramadan FastingStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Alwaleedi, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471646
- Sponsor's protocol ID
- HUM00247761
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. De-identified, aggregate results will be reported in publications and presentations.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ramadan Diurnal Fasting Combined With a Structed Aerobic Exercise on Body Composition and Cardiometabolic Health in Adults With Overweight and Obesity
- ClinicalTrials.gov ID
- NCT07471646
- Acronym / sponsor ID
- HUM00247761
- Conditions
- Ramadan Fasting, Obesity & Overweight, Aerobic Exercise, Weight Loss
- Keywords
- Ramadan fasting, Body composition, metabolic health, obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 May 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Ramadan diurnal fasting only group (RDF) | No intervention | –Participants observe Ramadan diurnal fasting without a structured exercise program. |
| Ramadan Fasting + Exercise | Experimental | Behavioral: Moderate-Intensity Aerobic ExerciseParticipants observe Ramadan diurnal fasting and participate in a supervised moderate-intensity aerobic exercise program performed approximately 5 days per week during the fasting period. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 20-60
- Body mass index (BMI) ≥27 kg/m²
- Planning to observe Ramadan diurnal fasting for the duration of Ramadan
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moderate-Intensity Aerobic ExerciseParticipants 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 | Behavioural | Ramadan Fasting + Exercise |
Primary outcome
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)
5 secondary outcomes
Glycemic control
Time frame: 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)
Resting metabolic rate
Time frame: 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)
Tumor necrosis factor-alpha (TNF-α)
Time frame: From enrollment until the end of the month of Ramadan (week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. De-identified, aggregate results will be reported in publications and presentations.
Related trials for Ramadan Fasting
RecruitingPhase 3
A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting
Diabetes Mellitus, Type 2, Diabetes Melletus
Active, not recruitingEarly Phase 1
Optimization of Basal Insulin During Ramadan Fasting in Type 2 Diabetic Patients: Comparison Between DAR Recommendations and the Carbohydrate Fasting Test & Metabolic and Inflammatory Consequences
Diabetes Mellitus, Type 2 Treated With Insulin, Fasting, Intermittent
Not yet recruitingObservational study
Mitophagy and Mitochondrial DNA Dynamics During Ramadan Dry Fasting vs 16:8 Time-Restricted Feeding
Mitochondrial Degradation, Autophagy
RecruitingObservational study
Knowledge, Attitudes, Practices & Perspectives on Pregnant Muslims Fasting Ramadan
Healthcare Professionals, Awareness and Knowledge Level
Not yet recruiting
Risks of Ramadan Fasting in Patients With Primary Adrenal Insufficiency Treated With Prednisolone.
Primary Adrenal Insufficiency, Ramadan Fasting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moderate-Intensity Aerobic Exercise in people with Ramadan Fasting and Obesity & Overweight, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total body fat mass (time frame: From enrollment to the end of the month of Ramadan (week 10)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.