To observe the acute (at termination) and long-term (at 6 weeks after termination) effect of the Ramadan fast on body weight, glucose metabolism, lipid spectrum and body composition of obese adolescents.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the effect of the Ramadan on changes in weight
status from baseline, measured as Z-BMI score.
Secondary outcome
Secondary endpoints are the effects of the Ramadan on glucose metabolism,
insulin resistance; serum levels of total, HDL- and LDL-cholesterol,
triglycerides, hs-CRP and body composition.
Background summary
The Ramadan fast is a month-long religious fast engaged by many Muslim
families, including children and adolescents. Recent data in adults suggest
that the Ramadan fast may result in weight loss and improved glucose and lipid
levels of those who participate. However, contradicting results exist about the
effect of the Ramadan fast on body composition. Thus far, this has not been
studied in obese adolescents.
We hypothesize that the obese adolescents participating in the Ramadan will
improve their weight status (expressed as a smaller standardised body mass
index; Z-BMI score) and their metabolic profile, reflecting in a decrease of
serum fasting glucose levels, serum LDL- and total-cholesterol and triglyceride
levels, increase of HDL-cholesterol and improved body composition after the
month of Ramadan fast.
Study objective
To observe the acute (at termination) and long-term (at 6 weeks after
termination) effect of the Ramadan fast on body weight, glucose metabolism,
lipid spectrum and body composition of obese adolescents.
Study design
Observational study of the effects on the weights status and metabolic profile
of adolescents that participate in the Ramadan fast. Data on anthropometrics,
glucose metabolism and lipid spectrum before the start, in the 4th week and 6
weeks after the Ramadan will be collected. Three 24h food diaries will be
collected in the first, second and last week of the Ramadan. A calander will be
used to determine how many days of the Ramadan where spent not fasting and/or
abroad. The duration of the study will be approximately 13 weeks.
Study burden and risks
Considering the increasing rate of obesity and metabolic disturbances in youth,
it is relevant to study the effects of the Ramadan fast on weight status and
the metabolic profile in this population. The results may also aid
pediatricians to give clinical advice about potential benefits and risks of
participation in the Ramadan fast in the future. A calender and three 24 hour
food diaries will be collected to gain insight in caloric intake and four
visits to the Slotervaart Hospital for physical examination and blood sample
drawing are needed. There are minimal risks involved and it is part of the
standard work-up at the pediatric obesity outpatient clinic at the Slotervaart
Hospital.
Louwesweg 6
Amsterdam 1066 EC
NL
Louwesweg 6
Amsterdam 1066 EC
NL
Listed location countries
Age
Inclusion criteria
- Paticipation in the Ramadan fast
- Age between 12-18 years
- Obesity as defined by Z-BMI score >2.3 (22)
- A written informed consent from participant as well as both parents (or guardian)
Exclusion criteria
- Obesity induced by underlying pathology, such as endocrine, a syndrome or chromosomal disorders, or chronic use of medication
- Pre-existing renal function disorder, diabetes mellitus or familial hypercholesterolemia
- Pregnancy
- Language barrier
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL40446.048.12 |