|- candidate number||6901|
|- NTR Number||NTR2173|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-jan-2010|
|- Secondary IDs||NL30728.081.09 MEC Wageningen|
|- Public Title||Oral and gastric contribution to satiety.|
|- Scientific Title||Oral and gastric contribution to satiety.|
|- hypothesis||Oral and gastric stimulation both affect satiety. We hypothesize that oral and gastric stimulation increases subjective feelings of satiety and lowers subsequent food intake. In addition it is expected that subjective feelings of satiety are highest and subsequent food intake is lowest when high oral stimulation is combined with high gastric filling.|
|- Healt Condition(s) or Problem(s) studied||Eating behaviour|
|- Inclusion criteria||1. Gender: male;|
2. Age: ≥ 18 years and ≤ 40 years;
3. BMI: ≥ 20 and < 25 kg/m2;
4. Stable body weight (change of < 2 kg body weight in last month);
5. Good physical and mental health as judged by the participant himself.
|- Exclusion criteria||1. Smoking or drug use;|
2. Gastro-intestinal diseases;
3. Diabetes, thyroid diseases or any other endocrine disorders;
4. Lack of appetite for any reason;
5. Restraint eating DEBQ score ≥ 2.26 (above average) ;
6. Hypersensitivity or food allergy for products used in this study, that are present in the cake;
7. Unsuccessful placement of the naso-gastric tube at the training visit;
8. Intolerance to placement of the naso-gastric tube or to the intra-gastric infusion of liquid food at the training visit;
9. Recovery of the test product after shamfeeding < 85% (dry mass) at the training visit;
10. Pleasantness rating of the ad libitum test meal offered during training < 40 mm (100 mm VAS);
11. Currently participating or having participated in another clinical trial at the Division of Human Nutrition during the last 3 months prior to the beginning of this study;
12. Taking any medication;
13. Problems with respiratory tract, such as hyperventilation, asthma or bronchitis, that can cause problems when the naso-gastric tube is inserted;
14. Working at, or doing an MSc thesis at the Division of Human Nutrition.
|- mec approval received||yes|
|- multicenter trial||no|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-feb-2010|
|- planned closingdate||7-mei-2010|
|- Target number of participants||35|
|- Interventions||Oral and gastric stimulation:|
1. Oral: 1 min (low) or 8min (high) modiefied sham feeding;
2. Gastric: infusion of 100ml (low) or 800ml (high) of a cake solution into the stomach with a naso-gastric tube.
|- Primary outcome||Subsequent food intake, as measured with ad libitum lunch intake 30 minutes after start of the oral and gastric stimulation.|
|- Secondary outcome||Subjective feeling so satiety as measured with a Visual Analogue Scale (VAS).|
|- Timepoints||There will be 5 testsessions with in each session:|
1. Ad libitum lunch intake 30 min. after start of oral and gastric stimulation;
2. VAS questionnaire: 9, 15, 30 and 60 minutes after start of oral and gastric stimulation.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Anne Wijlens|
|- CONTACT for SCIENTIFIC QUERIES||Prof. K. Graaf, de|
|- Sponsor/Initiator ||Wageningen University, Department of Human Nutrition|
(Source(s) of Monetary or Material Support)
|Nestle Research Centre|
|- Brief summary||Rationale:|
One of the major issues in the current food-rich environment is that many popular foods promote a positive energy balance, because the consumption of these foods leads to a relatively low satiety feeling relative to their energy content. One of the reasons for this may be their swift passage through the mouth, which decreases sensory signalling. This decreased sensory signalling may lead to diminished CPRs and lower sensory satiety. Consumption of fast foods, like caloric liquids an highly energy-dense foods may disrupt the learned connection between sensory signaling and their physiological consequences and therby CPRs.
In order to prevent a positive energy balance upon consumption of energy dense food products, there is a need to know how sensory and gastric signals and their interaction affect satiety. The understanding of which food properties have an impact on the oral and gastric contributions to satiety creates opportunities to optimize food products in such a way that satiety is maximized.
The primary objective of this clinical trial is to determine the effects of high oral and gastric stimulation on subsequent food intake.
The secondary objectives are:
1. What is the effect of oral stimulation (low vs. high) and different gastric stimulations (low/high) on subsequent food intake;
2. Is there an effect of oral and gastric stimulation on subjective feelings of satiety;
3. What is the effect of different oro-sensory stimulation and gastric filling on subjective feelings of satiety.
This is a randomized, cross over, single center, clinical trial with 5 treatments: A) control with no oral or gastric stimulation, B) low oral stimulation/ low gastric stimulation, C) high oral stimulation/ low gastric stimulation, D) low oral stimulation/ high gastric stimulation, E) high oral stimulation/ high gastric stimulation.
35 healthy men, Age: ≥ 18 and ≤ 40 years, BMI: ≥ 20 and < 25 kg/m2, stable body weight (change of < 2 kg body weight in last month), tolerating the treatments.
Description of study groups:
This experiment has a cross-over design, with two factors: oral stimulation with food (low = 1 minute and high = 8 minutes) stimulation and an isocaloric (100 kcal) intra-gastric load (low = 100 g, high = 800 g). The control condition will be without oral stimulation and without an intra-gastric load.
Product(s) to be tested:
The product applied in all study groups will be a commercially available pound cake.
The main outcome measure is ad libitum energy intake during a lunch meal, served 30 minutes after the start of gastric infusion/oral stimulation. To measure energy intake, a pre-determined amount of sandwiches will be provided to the subjects. Left-overs will be weighed and chemical analyses will be performed to check for the actual composition and energy content.
Secondary outcomes measures are subjective feelings of satiety that are measured via Visual Analogue Scale ratings. Hunger, fullness, prospective consumption, desire to eat, desire to eat something sweet, desire to eat something savoury, wellness and nauseous feelings will be rated.
|- Main changes (audit trail)|
|- RECORD||20-jan-2010 - 10-jun-2012|