To asses whether the success of protein diets is related to predisposition of overweight and sensitivity for food-reward
ID
Source
Brief title
Condition
- Appetite and general nutritional disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Differences in brain plasticity of reward
2. Differences in the FTO and TaqIA genes.
Secondary outcome
measurements of hunger suppression using visual analogue scales and ghreline
determination
Background summary
Overweight is a major health problem with serious co morbidities. Weight loss
is usually achieved more readily than weight maintenance after body weight
loss. Conditions for weight maintenance after weight loss are (a) sustained
satiety despite negative energy balance, (b) sustained basal energy expenditure
despite body weight loss, due to (c) sparing of fat-free mass, which is the
main determinant of basal energy expenditure. Diets with a relatively
high-protein content act on these metabolic targets (4). Increasing the
relative protein content reduces food intake under ad libitum conditions,
resulting in immediate body weight loss. In the long term, body weight reaches
a new value at a significantly lower level. Thus, an increase in the relative
protein content of the diet, irrespective of protein type, reduces the risk of
a positive energy balance and the development of overweight. Increasing protein
intake also increases the chance of maintenance of body weight after weight
loss induced by an energy-restricted diet.
So the most successful diets are those with a relatively high-protein content.
But compliance remains an issue with all diets. In the first place it will be
assessed whether predisposition for overweight affects compliance and success;
second, whether sensitivity for food-reward affects compliance and success.
Study objective
To asses whether the success of protein diets is related to predisposition of
overweight and sensitivity for food-reward
Study design
The study has a double blind parallel 2-arm design, with 2 conditions (diets).
There are 2 different diets: one that is relatively high in protein and one
with normal protein content. The subjects (n=300, BMI>25, age 18-55) first have
a three-month period of weight loss during which they are on the same weight
loss diet consisting of the commercially available meal substitute: modifast.
This is followed by a six-month period of weight maintenance during which the
subjects are randomized in 2 diet groups. Of the 300 subjects that complete the
weight loss and weight maintenance, the polymorphisms of the TaqIA gene and the
FTO gene are determined together with anthropometry measurements (body weight,
body composition, waist-hip ratio and sagital diameter); of these 300, 88 will
be assessed in the fMRI to investigate the brain areas involved in plasticity
of reward with respect to food.
In total there are three measurement moments: before the weight loss, before
the weight maintenance and after the weight maintenance at which anthropometry
measurements are taken and the fMRI investigations are conducted. Compliance
is determined by magnitude of weight loss.
Intervention
Weight loss using a commercial available meal substitute: modifast.
Weight maintenance during which the subjects are assigned to 1 of 2 diets: a
relatively high protein diet and a diet with normal protein content
Study burden and risks
This research is neither beneficial nor harmful to the subjects. fMRI is a
non-invasive standard brain-imaging method without any significant risks (See
chapter K4A for standardized and approved methods for conducting fMRI
experiments involving human subjects). It is a technique that utilizes magnetic
fields and low energy radio frequencies to visualize brain structures and brain
function. During screening subjects with metallic fragments in their body will
be excluded from the study since the fMRI magnet exerts a force on
ferromagnetic objects. The blood sampling in this study does not include any
other risks for the subjects, apart from its usual risk of minor bruising.
universiteitssingel 50
6229 ER Maastricht
NL
universiteitssingel 50
6229 ER Maastricht
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for the whole study are being healthy (no medication use except contraception), both genders, age between 18-55 years (over the age of 55 basal metabolic rate is diminished because of loss of muscle mass, which has an influence on weight loss), BMI over 25 kg/m2 (Following a long intervention on a restrictive protein diet would not be advisable with a BMI under 25), non-smoker (smoking affects appetite and reward) and weight loss during the weight loss phase of at least 0.5 kilo every week.
For the subjects that are included for the fMRI extra inclusion criteria are as follows: not having any metallic fragments in the body, being right-handed. Because of the different brain laterality in left- and right-handed subjects we chose to include only right-handed subjects. Hence the results can be compared between the subjects.
Exclusion criteria
Exclusion criteria are: use of medication (except contraception), extensive alcohol consumption (more than 10 consumptions per week), instable weight (changed more than 5 kilo over the last year), smoking, pregnancy, breast feeding, menopause, diabetes, claustrophobia, depression, hypertension, kidney dysfunctions, other serious disorders (for example epilepsy, arrhythmia, parkinsonism, insomnia) and less then 0.5 kilo weight loss in one week during the weight loss phase. For the subjects that are included for the fMRI extra exclusion criteria are as follows: having metallic fagments in the body, being left-handed.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL30898.068.09 |
Other | TC = 2174 |
OMON | NL-OMON25100 |