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Protein status and food reward.


- candidate number11134
- NTR NumberNTR3288
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-feb-2012
- Secondary IDs12/02 / NL39292.081.11; MEC Wageningen / ABR
- Public TitleProtein status and food reward.
- Scientific TitleProtein status and food reward.
- ACRONYMProBrain
- hypothesisThe protein status of an individual effects food preferences and intake. If the protein status is low, products high in protein will elicit greater reward.
- Healt Condition(s) or Problem(s) studiedEating behaviour
- Inclusion criteria1. Age: 18-35 years;
2. BMI: 18.5 – 25.0 kg/m2;
3. Healthy (as judged by the participant).
- Exclusion criteria1. Restraint eating (men: score > 2.25; women: score > 2.80) (17);
2. Lack of appetite;
3. Having difficulties with swallowing/eating;
4. Usage of an energy restricted diet during the last two months;
5. Weight loss or weight gain of 5 kg or more during the last two months;
6. Stomach or bowel diseases;
7. Kidney disorders;
8. Diabetes, thyroid disease, other endocrine disorders;
9. Having a history of neurological disorders;
10. Having taste or smell disorders;
11. Usage of daily medication other than birth control pills;
12. Pregnant or lactating;
13. Smoking more than one cigarette a day;
14. Being a vegetarian;
15. Being allergic/intolerant for products under study;
16. Working at the division of human nutrition (WUR);
17. Having participated in ‘ProTime’, or current participation in other research from the division of Human Nutrition (WUR);
18. Having a contra-indication to MRI scanning (including, but not limited to):
A. Claustrophobia;
B. Epilepsy or a family history of epilepsy;
C. Serious physical or mental illnesses;
D. Pacemakers and defibrillators;
E. Intraorbital or intraocular metallic fragments;
F. Ferromagnetic implants;
G. Presence of any other metal object e.g. in the mouth;
H. Being lefthanded.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-mrt-2012
- planned closingdate16-jun-2012
- Target number of participants24
- InterventionsTwo 16-day fully controlled intervention periods differing in dietary protein intake. These interventions involve consumption of individualized, iso-energetic menus providing either 0.5 g protein/kg bodyweight/day (low protein diet) or 2.0 g protein/kg bodyweight/day (high protein diet).
- Primary outcomeThe primary objective of this study is to assess the effect of a low protein status on reward response when exposed to sight and smell of food stimuli high and low in protein compared with a high protein status.
- Secondary outcome1. To assess the effect of a low protein status on different aspects of food reward: the explicit liking, the explicit wanting, the implicit wanting and a forced food choice of high and low protein food using the computerized Leeds Food Preference Questionnaire (LFPQ) compared with a high protein status;
2. To assess the effect of a low protein status on protein and energy intake compared with a high protein status.
- TimepointsEvery participant will visit the laboratory every day during the intervention periods.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc S. Griffioen-Roose
- CONTACT for SCIENTIFIC QUERIESMSc S. Griffioen-Roose
- Sponsor/Initiator Wageningen University, Department of Human Nutrition
- Funding
(Source(s) of Monetary or Material Support)
Technologiestichting STW (Stichting Technische Wetenschappen)
- PublicationsN/A
- Brief summaryRationale:
Protein is an indispensable component within the human diet. It has been posed that protein intake is tightly regulated in the human body. In a previous study we showed that following a protein deficit, food intake and food preferences changed to restore adequate protein status.

Objective:
The primary objective of this study is to assess the effect of a low protein status on reward response when exposed to sight and smell of food stimuli high and low in protein compared with a high protein status.

Study design:
The study will consist of a 16-day fully controlled dietary intervention that will involve consumption of individualized, isoenergetic menus providing either 0.5 g protein/kg BW/day (low protein diet), or 2.0 g protein/kg BW/day (high protein diet), using a randomized crossover design. The diets will be followed by a 1-day ad libitum-phase, where protein (g) and energy (kJ) intake will be measured. Changes of reward responses in the brain will be measured by using functional magnetic resonance imaging (fMRI) when exposed to sight and smell of high and low protein food stimuli. Food preference will be measured by subjective ratings.

Study population:
The study population will consist of 24 apparently healthy, unrestrained female volunteers between the age of 18 and 35 with a normal weight.

Main study parameters/endpoints:
Our main outcome measurement is the change in brain reward response to sight and smell of high and low protein food stimuli after the low protein and high protein diets.
- Main changes (audit trail)
- RECORD14-feb-2012 - 25-feb-2012


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