To determine ad libitum daily energy intake, energy balance and appetite profile in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, BMI and FTO polymorphisms.
ID
Source
Brief title
Condition
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this study are energy intake, energy balance and
appetite profile over 12 consecutive days.
Secondary outcome
n.v.t.
Background summary
Following the protein leverage hypothesis, energy intake may be a derivative of
protein intake. Therefore, in response to an unbalanced menu relative to the
usual daily intake target, protein intake should be prioritized. Individuals
may over-consume carbohydrate and fat of a menu containing a lower ratio of
protein to carbohydrate and fat until the daily intake target amount of protein
is ingested, and not the target of total energy intake because of a deficit of
protein intake. In contrast, individuals may under-consume energy when the menu
has an increased protein to carbohydrate and fat ratio. The protein leverage
hypothesis requires evidence for why protein intake is more important than
carbohydrate or fat in relation to food intake regulation.
Study objective
To determine ad libitum daily energy intake, energy balance and appetite
profile in response to protein/carbohydrate and fat ratio over 12 consecutive
days, and in relation to age, gender, BMI and FTO polymorphisms.
Study design
The study will be conducted in a crossover design with three randomly sequenced
conditions.
Intervention
Subjects will consume breakfast, lunch and dinner ad libitum in the lab, for 12
days per condition (three conditions: protein intake of 5, 15 and 30 energy
percent). Snacks will be provided in boxes for consumption at home. Daily total
energy intake will be measured, as well as hunger and satiety before and after
each meal. Body weight will be measured to assess energy balance, and 24-hour
urine nitrogen content to confirm protein intake. FTO polymorphisms will be
determined in order to determine the interaction of the genetic background of
the obesity related gene FTO and changes in energy intake.
Study burden and risks
The study does not include any major risk for the subjects. Anthropometric and
body composition measurements, performed during the screening, will not be
invasive for the subjects. Blood sampling is limited to one sample per subject.
There are no side effects, except from a minor risk of bruising. Urine sampling
will be done in urine bottles added with diluted HCl, which might pose a risk
for the subjects. However, subjects will be carefully instructed how to handle
the bottles to reduce these risks. Additionally, there are no risks for the
subject in consuming any of the provided meals, because people with certain
food allergies are excluded for participation and all food items will be
commercially available in normal Dutch supermarkets. This study does not have
any benefits for the subjects themselves, but will give possible new knowledge
for the treatment of obesity.
Postbus 616
6200 MD Maastricht
NL
Postbus 616
6200 MD Maastricht
NL
Listed location countries
Age
Inclusion criteria
Healthy, age 18-70 y, BMI 18-35 kg/m2, non-smoking, weight stable
Exclusion criteria
Smoking, use of medication, more than moderate alcohol consumption
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 |
|---|---|
| ClinicalTrials.gov | NCT01320189 |
| CCMO | NL36167.068.11 |