NCT07471646

Brief 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. 1.Does Ramadan diurnal fasting lead to changes in body composition and cardiometabolic health outcomes?
  2. 2.Does adding moderate-intensity aerobic exercise during Ramadan fasting result in greater improvements in cardiometabolic health compared with fasting alone?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2026

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 19, 2026

Status Verified

February 1, 2026

Enrollment Period

Same day

First QC Date

February 8, 2026

Last Update Submit

May 15, 2026

Conditions

Keywords

Ramadan fastingBody compositionmetabolic healthobesity

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (5)

  • Glycemic control

    From enrollment to the end of the month of Ramadan (week 10)

  • Lipids profile

    From enrollment until the end of the month of Ramadan (week 10)

  • Resting metabolic rate

    From enrollment until the end of the month of Ramadan (week 10)

  • Circulating concentrations of interleukin-6 (IL-6)

    From enrollment until the end of the month of Ramadan (week 10)

  • Tumor necrosis factor-alpha (TNF-α)

    From enrollment until the end of the month of Ramadan (week 10)

Study Arms (2)

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.

Behavioral: Moderate-Intensity Aerobic Exercise

Interventions

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

Ramadan Fasting + Exercise

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 20-60
  • Body mass index (BMI) ≥27 kg/m²
  • Planning to observe Ramadan diurnal fasting for the duration of Ramadan

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan School of Kinesiology

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

ObesityOverweightWeight Loss

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight Changes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
This is an open-label study; no participants, investigators, or outcome assessors are masked due to the nature of the fasting and exercise intervention.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Graduate Student Research Assistant

Study Record Dates

First Submitted

February 8, 2026

First Posted

March 13, 2026

Study Start

May 1, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

May 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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

Locations