|- candidate number||6877|
|- NTR Number||NTR2162|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||13-jan-2010|
|- Secondary IDs||09/22 / 29991.081.09 MEC Wageningen / ABR|
|- Public Title||The effect of protein content and taste on satiety.|
|- Scientific Title||The effect of protein content and taste on satiety.|
|- hypothesis||The protein content of a product has an influence on satiety, e.g. the higher the protein content, the lower the subsequent intake. |
In addition, a sensory specific satiety effect is expected, meaning that after eating a preload with a certain taste, the intake of products with a congruent taste is less than of products with an incongruent taste.
|- Healt Condition(s) or Problem(s) studied||Eating behaviour|
|- Inclusion criteria||1. Age: 18-35 year;|
2. BMI: 18.5 ¨C 25.0 kg/m2;
3. Healthy (as judged by the participant);
4. Liking for test products (assessed in screening-questionnaire with a 9-point hedonic scale, subjects have to like or have a neutral attitude towards the products: score ¡İ 5).
|- Exclusion criteria||1. Restraint eating (men: score > 2.25; women: score > 2.80) ;|
2. Lack of appetite for any (unknown) reason;
3. Usage of a energy restricted diet during the last two months;
4. Weight loss or weight gain of 5 kg or more during the last two months;
5. Stomach or bowel diseases;
6. Diabetes, thyroid disease, or any other endocrine disorder;
7. Having difficulties with swallowing/eating;
8. Hypersensitivity (allergy and/or intolerance) for the food products under study;
9. Smoking (at least one cigarette a day);
10. For women: pregnant or lactating;
11. Being a vegetarian;
12. Having participated in '®RiceTime¡', '®LunchTime¡' or '®Smaak-Geur¡; 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 ||18-jan-2010|
|- planned closingdate||12-feb-2010|
|- Target number of participants||60|
|- Interventions||Lunchmeal, varying in protein content (high vs. low) and taste (sweet vs. savory).|
|- Primary outcome||The primary objective of this study to determine the effect of protein content (low vs. high) and taste (sweet vs. savory) of a meal on satiety, measured by subsequent intake of 4 different food categories (low-protein sweet, low-protein savory, high-protein sweet, and high-protein savory) at an ad libitum lunch buffet.
Therefore our main outcome is:
The difference in intake (g) of 4 different food categories (low-protein sweet, low-protein savory, high-protein sweet, and high-protein savory) at an ad libitum lunch buffet between the 4 different treatments.
|- Secondary outcome||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 4 different treatments measured with and computerized food preference questionnaire.|
|- Timepoints||Per individual 4 measuring time-points, between 18/01/2010 and 12/02/2010.|
|- Trial web site||N/A|
|- status||inclusion stopped: follow-up|
|- CONTACT FOR PUBLIC QUERIES||MSc S. Griffioen-Roose |
|- CONTACT for SCIENTIFIC QUERIES||MSc S. Griffioen-Roose |
|- Sponsor/Initiator ||Wageningen University, Division 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. A high-protein meal produces a significantly greater reduction in liking for high-protein foods than for high-carbohydrate foods. And as products with a savory taste are in general higher in protein levels while food products with a sweet taste are more related with carbohydrates, a link between taste and macronutrient in control of intake seems to exist. This link, however, is far from clear.
To determine the effect of protein content (low vs. high) and taste (sweet vs. savory) of a meal on satiety, measured by subsequent intake of 4 different food categories (low-protein sweet, low-protein savory, high-protein sweet, and high-protein savory).
The study is a cross-over intervention study and has a 2x2 factorial design, the 2 factors being protein content (low and high) and taste (sweet and savory) of a meal, resulting in 4 different treatments.
Each subject participates in all 4 treatments whereby the order is randomized according to a Latin square. Subjects will be offered a (rice) meal (fixed preload), varying in protein content and taste. After finishing, subsequent intake of 4 different food categories (low-protein sweet, low-protein savory, high-protein sweet, and high-protein savory) at an ad libitum lunch buffet is measured.
The study population will consist of 60 apparently healthy, non-smoking, unrestrained volunteers between the age of 18 and 35 with a normal weight.
Main study parameters/endpoints:
Our main outcome measure is the difference in intake (g) of the 4 food categories at an ad libitum lunch buffet between the 4 different treatments.
|- Main changes (audit trail)|
|- RECORD||13-jan-2010 - 20-jan-2010|