|- candidate number||8398|
|- NTR Number||NTR2491|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||1-sep-2010|
|- Secondary IDs||10/09 / 32871.081.10 ; MEC Wageningen / ABR|
|- Public Title||The effect of protein status on food preferences and intake.|
|- Scientific Title||The effect of protein status on food preferences and intake.|
|- hypothesis||The protein status of an individual effects food preferences and intake. If the protein status is high, choice and intake of high-protein foods will be decreased. If the protein status is low, choice and intake of high-protein foods will be increased.|
|- Healt Condition(s) or Problem(s) studied||Eating behaviour|
|- Inclusion criteria||1. Age: 18-35 years;|
2. BMI: 20.0 - 25.0 kg/m2;
3. Healthy (as judged by the participant).
|- Exclusion criteria||1. Restraint eating (men: score > 2.25; women: score > 2.80);|
2. Lack of appetite;
3. Having difficulties with swallowing/eating;
4. Usage of a 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. Prevalent cardiovascular disease;
10. A systolic blood pressure of ≥ 160 mmHg at screening;
11. Usage of daily medication other than birth control pills;
12. For women: pregnant or lactating;
13. Being a vegetarian;
14. Being allergic/intolerant for products under study;
15. Having participated in studies that have used the LFPQ: RiceTime, LunchTime, Smaak-Geur», SenSation, and ProStudy, or current participation in other research from the division of human nutrition (WUR).
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||27-sep-2010|
|- planned closingdate||19-nov-2010|
|- Target number of participants||40|
|- Interventions||Two 14-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 outcome||The difference in protein intake (g) during a 2-day ad libitum-phase following the two interventions.|
|- Secondary outcome||1. The difference in energy intake during the 2-day ad libitum-phase following the two interventions;|
2. The difference in subjective appetite ratings during the low protein diet and the high protein diet measured with a visual analogue scale (VAS) hourly during the waking hours of a single 24h period on the last day of the normal protein diet and on the first day and last day of the two interventions;
3. The difference on explicit liking (ratings on VAS), explicit wanting (ratings on VAS), implicit wanting (reaction time in food choice), and food preference (frequency) per food category between the 2 interventions measured with the LFPQ;
4. The difference in systolic blood pressure (measured at the end of each intervention) following the two interventions.
|- Timepoints||Every participant will visit the laboratory every day during the intervention periods. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc S. Griffioen-Roose |
|- CONTACT for SCIENTIFIC QUERIES||MSc S. Griffioen-Roose |
|- Sponsor/Initiator ||Wageningen University, Department of Human Nutrition|
(Source(s) of Monetary or Material Support)
|Technologiestichting STW (Stichting Technische Wetenschappen)|
|- Brief summary||Rationale: |
It has been posed that protein intake is tightly regulated in the human body. It has been shown that when subjects have eaten high-protein meals, a significantly greater reduction is seen in liking for high-protein food than for high-carbohydrate foods. In our previous research, we did not observe this effect within one meal. Animal and human studies suggest that energy and macronutrient balance are regulated over a longer period of time.
To determine the effect of protein status on food preferences and intake.
The study will consist of two 14-day fully controlled dietary interventions that 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 interventions will be followed by a 2-day ad libitum-phase, where protein intake (g) will be measured. Both interventions will be preceded by 2 days on which subjects eat a normal protein diet. The interventions will be separated by a minimum of 1 week washout.
The study population will consist of 40 apparently healthy, unrestrained volunteers between the age of 18 and 35 with a normal weight.
Main study parameters/endpoints:
Our main outcome measurement is the difference between protein intake (g) during the 2-day ad libitum-phase following the two interventions.
|- Main changes (audit trail)|
|- RECORD||1-sep-2010 - 9-sep-2010|