Effects of Ramadan Fasting With Exercise on Cardiometabolic Health

May 15, 2026 updated by: Abdullah Alwaleedi, University of Michigan

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:

  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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan School of Kinesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Ramadan diurnal fasting only group (RDF)
Participants observe Ramadan diurnal fasting without a structured exercise program.
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.
Behavioral: Moderate-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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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)
From enrollment to the end of the month of Ramadan (week 10)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
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)
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)
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)
From enrollment until the end of the month of Ramadan (week 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 10, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HUM00247761

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared publicly. De-identified, aggregate results will be reported in publications and presentations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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