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Diet, predisposition and reward.


- candidate number6905
- NTR NumberNTR2174
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jan-2010
- Secondary IDsNL30898.068.09 CCMO
- Public TitleDiet, predisposition and reward.
- Scientific TitleIs the success of protein diets related to predisposition of overweight and sensitivity for food-reward?
- ACRONYMDiet, predisposition and reward
- hypothesis 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.
- Healt Condition(s) or Problem(s) studiedOverweight, Obesity, Weight maintenance, Polymorphisms, Brain plasticity of reward
- Inclusion criteriaInclusion criteria for the whole study are being healthy (no medication use except contraception), both genders, age between 18-55 years, BMI over 25 kg/m2, non-smoker.
For the subjects that are included for the fMRI extra inclusion criteria are as follows: not having any metals in the body, being right-handed.
- Exclusion criteriaExclusion 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), pregnancy, depression, hypertension, kidney dysfunctions and other serious disorders (for example epilepsy, arrhythmia, parkinsonism, insomnia).
For the subjects that are included for the fMRI extra exclusion criteria are as follows: having metals in the body, being left-handed and claustrophobia.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-feb-2010
- planned closingdate1-mrt-2012
- Target number of participants300
- Interventions 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.

Thus:
1. Weight loss using a commercial available meal substitute: modifast;
2. 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.
- Primary outcome1. Differences in success between the diets (anthropometry measurements);
2. Differences in brain plasticity of reward;
3. Differences in the FTO and TaqIA genes.
- Secondary outcomeMeasurements of hunger suppression using visual analogue scales and ghreline determination.
- Timepoints1. Baseline (before weight loss);
2. After 6 months of weight loss;
3. After 3 months of weight maintenance.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD Mieke Martens
- CONTACT for SCIENTIFIC QUERIESProf. dr. Margriet Westerterp
- Sponsor/Initiator Maastricht University Medical Center (MUMC+)
- Funding
(Source(s) of Monetary or Material Support)
Top Institute Food & Nutrition
- PublicationsN/A
- Brief summaryOverweight 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.
- Main changes (audit trail)
- RECORD21-jan-2010 - 11-feb-2010


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