Energy Expenditure During Ramadan Fasting Clinical Trial
— RAMEEOfficial title:
Ramadan and Energy (RAMEE) Study
| NCT number | NCT02696421 |
| Other study ID # | IREC 022 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2015 |
| Est. completion date | December 2018 |
| Verified date | October 2018 |
| Source | Imperial College London Diabetes Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Recruiting |
| Enrollment | 200 |
| Est. completion date | December 2018 |
| Est. primary completion date | November 2018 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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) |
| Country | Name | City | State |
|---|---|---|---|
| United Arab Emirates | Imperial College London Diabetes Centre | Abu Dhabi |
| Lead Sponsor | Collaborator |
|---|---|
| Imperial College London Diabetes Centre |
United Arab Emirates,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Resting metabolic rate | 3 months | ||
| Primary | 24 hour energy expenditure | 3 months |