Ramadan and Energy Expenditure Study (RAMEE)

October 11, 2018 updated by: Imperial College London Diabetes Centre

Ramadan and Energy (RAMEE) Study

Ramadan fasting entails abstinence from eating and drinking between dawn and sunset. During this month major changes in meal times and patterns, sleeping times and activity occur. Starvation is known to lead to a compensatory reduction in energy expenditure. However, the Ramadan fast is not synonymous with starvation as it involves intermittent periods of fasting followed by gorging. People who fast during Ramadan feel less energetic. However, little is known about the effects of this religious practice on energy metabolism. .

The aim of this study is to assess energy dynamics before and/or after and during Ramadan fasting in non-obese participants. Resting metabolic rate (RMR), thermic effect of food (TEF), active energy expenditure (AEE) and total energy expenditure (TEE) in free-living conditions will be measured . Indirect calorimetry will be used to assess RMR and TEF, doubly labeled water will be used to measure TEE and activity monitors will measure physical activity. In addition, body composition analysis will be performed by bio-electrical impedance. Blood sample will be taken to exclude medical factors affecting energy metabolism.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

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

Study Locations

  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 48338
        • Recruiting
        • Imperial College London Diabetes Centre

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

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Up to 50 healthy non-obese (BMI: 20-30) subjects (age: 18-70) will be recruited. We will aim for equal representation of men and women.

Physically and mentally healthy. Consent form signed.

Description

Inclusion Criteria:

  • Willing to participate.
  • Age (18-70) years.
  • BMI (20-30 kg/m2).
  • Physically and mentally healthy.
  • Consent form signed.

Exclusion Criteria:

  • Any patients with significant health problem.
  • Pregnant and lactating females.
  • Smokers.
  • Consumption of caffeine before tests.
  • Patients who have had vigorous exercise for the last 12 hours before visit.
  • Patients with diabetes treated with drugs known to alter the metabolic rate.
  • Patients who had bariatric surgery.
  • Patients with eating disorders.
  • Patients with conditions known to affect energy expenditure
  • Patients on medication know to alter EE (Thyroxine, anti-thyroid drugs, certain cold remedies)

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

Cohorts and Interventions

Group / Cohort
Non diabetic, non obese
Non diabetic obese
Diabetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Resting metabolic rate
Time Frame: 3 months
3 months
24 hour energy expenditure
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Imperial College London Diabetes Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2015

Primary Completion (Anticipated)

November 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

June 15, 2015

First Submitted That Met QC Criteria

February 25, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 15, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • IREC 022

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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