Energy Expenditure During Ramadan FastingRAMEENCT02696421
Ramadan and Energy Expenditure Study
An observational study of Energy Expenditure During Ramadan Fasting, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Expenditure During Ramadan Fasting
- How many people
- 200 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- Jun 2015to Dec 2018
- Phase
- Observational
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Willing to participate.
- Age (18-70) years.
- BMI (20-30 kg/m2).
- Physically and mentally healthy.
- Consent form signed.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Imperial College London Diabetes Centre
Abu Dhabi, 48338
Nader G Lessan, 024040800 ext. 970, nlessan@icldc.ae
Nader Lessan, MBBS MD FRCP CCST
About this study
Official title: 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non diabetic, non obese | Not described | |
| Non diabetic obese | Not described | |
| Diabetic | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting metabolic rate
Measured: 3 months
24 hour energy expenditure
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startJun 2015
- Primary completionNov 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy Expenditure During Ramadan FastingStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London Diabetes Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696421
- Sponsor's protocol ID
- IREC 022
- Acronym
- RAMEE
- Status last verified
- Oct 2018
- First submitted
- 15 Jun 2015
- Last updated
- 15 Oct 2018
- Results posted
- No
Publications
Lessan N, Saadane I, Alkaf B, Hambly C, Buckley AJ, Finer N, Speakman JR, Barakat MT. The effects of Ramadan fasting on activity and energy expenditure. Am J Clin Nutr. 2018 Jan 1;107(1):54-61. doi: 10.1093/ajcn/nqx016.
PubMed 29381798
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ramadan and Energy (RAMEE) Study
- ClinicalTrials.gov ID
- NCT02696421
- Acronym / sponsor ID
- RAMEE / IREC 022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Imperial College London Diabetes CentreUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- 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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Non diabetic, non obese | – | – |
| Non diabetic obese | – | – |
| Diabetic | – | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- Willing to participate.
- Age (18-70) years.
- BMI (20-30 kg/m2).
- Physically and mentally healthy.
- Consent form signed.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Resting metabolic rate
Time frame: 3 months
24 hour energy expenditure
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 29381798Lessan N, Saadane I, Alkaf B, Hambly C, Buckley AJ, Finer N, Speakman JR, Barakat MT. The effects of Ramadan fasting on activity and energy expenditure. Am J Clin Nutr. 2018 Jan 1;107(1):54-61. doi: 10.1093/ajcn/nqx016.
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.
Imperial College London Diabetes Centre
Abu Dhabi, United Arab Emirates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Energy Expenditure During Ramadan Fasting, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
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 5 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Oct 2018. 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 Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting metabolic rate (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696421, which also lists 1 linked publication.
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 15 Oct 2018.