|- candidate number||8563|
|- NTR Number||NTR2574|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-okt-2010|
|- Secondary IDs||NL34062.081.10 CCMO|
|- Public Title||MaalTijd-onderzoek.|
|- Scientific Title||Texture and energy density in learned satiation.|
|- hypothesis||Ad libitum intake of meal items will be lower in the semi-solid food conditions compared to the liquid food conditions. In addition, there will be no effect on intake of energy density in the liquid group, whereas there is a energy density effect in the semi-solid test conditions.|
|- Healt Condition(s) or Problem(s) studied||Overweight, Obesity, Eating behaviour, Energy intake|
|- Inclusion criteria||1. Young-adults: 18–35 years;|
2. Normal weight: BMI 18.5 – 25.0 kg/m2;
3. Eats breakfast regularly (≥5 times a week);
4. Apparently healthy (judged by the participant).
|- Exclusion criteria||1. Lack of appetite for any reason;|
2. Restraint eating (men: score >2.25; women: score >2.80 (14));
3. Using an energy restricted diet during the last 2 months;
4. Weight loss or weight gain of more than 5 kg during the last 2 months;
5. Stomach or bowel diseases;
6. Diabetes, thyroid disease, or any other endocrine disorder;
7. Hypersensitivity (allergy and/or intolerance) for food products under study;
8. Working at the division of Human Nutrition of Wageningen University;
9. Participation in the Zuivelproef-study (NL32016.081.10);
10. Aversion of comparison foods of computer-based photo program to assess expected satiation (assessed in screening questionnaire with 9-point hedonic scale; participants should not have an intense aversion [score 1] towards the comparison foods).
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||22-nov-2010|
|- planned closingdate||16-dec-2010|
|- Target number of participants||40|
|- Interventions||In a randomized cross-over design participants consume fixed amounts of:|
1. A liquid food with a low energy density;
2. A liquid food with a high energy density;
3. A semi-solid food with a low energy density;
4. A semi-solid food with a high energy density.
The test foods will be a fixed part of breakfast, lunch and dinner on day 1, 2 and 3, and total intake will be measured during consecutive meals.
On day 4, ad libitum intake of the test food will be measured at breakfast.
|- Primary outcome||Ad libitum intake in kcal/day of meal items that are provided in addition to the test foods.|
|- Secondary outcome||1. Change in Expected satiation;|
3. Ad libitum intake.
|- Timepoints||1. All meal occasions on day 1 to 4 (Mo-Th);|
2. 4 conditions (4* Mo-Th) in total.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||MSc P.S. Hogenkamp|
|- CONTACT for SCIENTIFIC QUERIES||MSc P.S. Hogenkamp|
|- Sponsor/Initiator ||TI Food & Nutrition|
(Source(s) of Monetary or Material Support)
|Top Institute Food & Nutrition|
|- Brief summary||Objective:|
The primary objective of this study is to determine the effect of texture and energy density on learned satiation. Energy adjustment is assessed by measuring ad libitum intake (kcal/day) of meal items provided in addition to the test foods which are offered in a fixed amount.
The study population will consist of 40 apparently healthy, unrestrained volunteers, aged between 18 and 35 y, with a normal weight.
In a randomized cross-over design, participants will consume either:
1. A low-energy-dense liquid test food;
2. A high-energy-dense liquid test food;
3. A low-energy-dense semi-solid test food;
4. A high-energy-dense semi-solid test food.
In each test condition, total intake during breakfast, lunch, dinner will be measured on consecutive days (day 1 to 3), with the test food as obligatory part of all meals. On day 4, the test food will be offered ad libitum for breakfast and intake will be measured.
Ad libitum intake (kcal/day) of meal items provided in addition to the test foods. As secondary outcomes, expected satiation and pleasantness of the test foods will be assessed before and after repeated consumption. In addition, the test food will be offered ad libitum for breakfast and intake will be measured.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
The study is non-therapeutic to the participant and no invasive measurements are present. The risk associated with participation is negligible. Compared to other studies the burden can be considered as low. Participants will be offered financial compensation after completion of the study.
|- Main changes (audit trail)|
|- RECORD||22-okt-2010 - 31-okt-2010|