To determine ad libitum daily energy intake in response to protein/carbohydrate and fat ratio over 12 consecutive days, and in relation to age, gender, BMI and FTO gene alleles.
ID
Source
Brief title
Condition
- Metabolism disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of this study is energy intake over 12 consecutive days.
Secondary outcome
The secondary endpoints of this study are body weight changes and appetite
profile over 12 consecutive days.
Background summary
The protein leverage hypothesis requires specific evidence whether energy
intake would depend on a possible protein intake target in humans. Meat protein
as complete protein may show most beneficial effects on variables regarding
food intake regulation.
Study objective
To determine ad libitum daily energy intake in response to protein/carbohydrate
and fat ratio over 12 consecutive days, and in relation to age, gender, BMI and
FTO gene alleles.
Study design
The study will be conducted in a crossover design with three randomly sequenced
experimental conditions.
Intervention
The study will be performed using diets containing 5 energy percent from
protein (low protein), 15 energy percent (normal protein) and 30 energy percent
(high protein). Beef protein will be used as main meat protein source in the
normal protein and high protein conditions. Subjects will consume breakfast,
lunch and dinner ad libitum in the research restaurant, for 12 consecutive days
in each of the protein-content conditions. Snacks will be provided in boxes for
consumption at home. 24-hour urine nitrogen content will be determined to
confirm protein intake. Energy intake, macronutrient intake, body weight, and
appetite profile will be measured. FTO gene alleles 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 largest disadvantage of this study is the required time for daily visiting
the University for the consumption of the meals. Test days will be scheduled in
agreement with the subjects, and during normal times for breakfast, lunch and
dinner to reduce strain on the subjects. The time investment will be maximal 5
hours per day.
There are no risks for the subjects in consuming any of the provided meals and
snacks, because people with certain food allergies are excluded for
participation and all food items will be commercially available in normal Dutch
supermarkets. Except for the provided meals and snacks, subjects are only
allowed to consume water, tea and coffee without milk and sugar. No other foods
or beverages are allowed during the test periods. However, a variety of food
items will be provided to prevent for one-sidedness during the test periods,
and subjects will always receive freshly prepared meals, without doing any
efforts as shopping or cooking. During the screening the liking of the provided
food items will be checked, and people who will not like the foods will be
excluded from participation in the study.
Anthropometric 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.
This study does not have any benefits for the subjects themselves, but will
give possible new knowledge for the treatment of obesity. The researchers are
aware that participation in the study is a great burden for the subjects, and
will express their sympathy. Subjects will be carefully treated, and their
well-being will be evaluated daily.
Universiteitssingel 50
Maastricht 6229 ER
NL
Universiteitssingel 50
Maastricht 6229 ER
NL
Listed location countries
Age
Inclusion criteria
BMI 18-35 kg/m2
Age 18-70 years
Healthy (absence of disease)
Non-smoking
Not using a more than moderate amount of alcohol (> 10 consumptions/wk)
Being weight stable (weight change < 3 kg during the last 6 months)
Not using medication or supplements except for oral contraceptives in women
Exclusion criteria
Not healthy (presence of disease)
Smoking
Using a more than moderate amount of alcohol
Not being weight stable
Using medication or supplements except for oral contraceptives in women
Not meeting the criteria for BMI and age
Pregnant or lactating
Allergic for used food items
Vegetarian
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 | NCT01646749 |
| CCMO | NL41371.068.12 |