|- candidate number||13259|
|- NTR Number||NTR3601|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-aug-2012|
|- Secondary IDs||12/16 / NL40863.81.12; MEC Wageningen /ABRnr.|
|- Public Title||Effect of oral exposure duration and gastric energy content on gastric emptying rate.|
|- Scientific Title||Effect of oral exposure duration and gastric energy content on gastric emptying rate.|
|- hypothesis||Oral exposure time and energy content of the gastric load both affect subjective feelings of satiety and gastric emptying rate. It is expected that a longer oral exposure time and a higher gastric energy content would both increase subjective feelings of satiety and that a high energy content of the gastric load would delay the rate of gastric emptying. |
|- Healt Condition(s) or Problem(s) studied||Eating behaviour|
|- Inclusion criteria||1. Gender: male;|
2. Age: 18 - 40 y;
3. BMI: 18.5 - 25.0 kg/m2;
4. Stable body weight (change of <5kg in the last 2 months);
5. Healthy: as judged by the participant;
6. Having signed the informed consent form.
|- Exclusion criteria||1. Smoking or drug abuse;|
2. Gastro-intestinal diseases;
3. Diabetes, thyroid diseases or any other endocrine disorders;
4. Lack of appetite for any reason;
5. Hypersensitivity or food allergy for products used in this study;
6. Currently participating in another clinical trial or planning to start participation during this study;
7. Taking any medication, except for light pain relieving medications which are available over the counter (acetylsalicylic acid or paracetamol);
8. Problems with the respiratory tract, such as hyperventilation, asthma or bronchitis, which can cause problems when the naso-gastric tube is inserted;
9. Working at, or doing an MSc. thesis at the Division of Human Nutrition of Wageninen University.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-sep-2012|
|- planned closingdate||2-nov-2012|
|- Target number of participants||27|
|- Interventions||Oral and gastric stimulation:|
Subjects receive (after inclusion, IC and training session) 5 treatments. 4 treatments with 2x2 design with:
1. Oral stimulation: 1 min or 8min modified sham feeding;
2. Gastric stimulation: Infusion of 500ml of liquid with 100kcal or 700kcal into the stomach with a naso-gastric tube.
Besides these 4 treatments there is a control condition: No oral stimulation but subjects are infused with a 500ml 0kcal (noncaloric) liquid.
|- Primary outcome||To determine the effect of short/long oro-sensory exposure combined with a gastric load low/high in energy, on the rate of gastric emptying.
|- Secondary outcome||To determine the effect of short/long oro-sensory exposure combined with a gastric load low/high in energy, on subjective feelings of satiety;|
|- Timepoints||Every subject will visit the laboratory 7 times:|
1. For an information and screening meeting;
2. For a training session (where all study procedures are practised;
3. 5 testsessions with in each session:
A. VAS questionnaire: Directly before, and and 8, 15, 22, 30, 45, 60, 75 and 90 minutes after start of the treatment;
B. Breath sample collection: 2 times before start of the treatment, and 8, 15, 22, 30, 45, 60, 75 and 90 minutes after start of the treatment.
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| Anne Wijlens|
|- CONTACT for SCIENTIFIC QUERIES|| Anne Wijlens|
|- Sponsor/Initiator ||Wageningen University, Division of Human Nutrition|
(Source(s) of Monetary or Material Support)
|Wageningen University, Division of Human Nutrition|
|- 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 of their low satiating efficiency per calorie. One of the reasons for this may be the quick passage through the mouth. How the mouth and the stomach influence each other with regards to gastric emptying is not fully understood.
Objective of the study:
The primary objective of this study is to investigate the effect of - short vs. long - oro-sensory exposure combined with a gastric load - low vs. high in energy -, on gastric emptying rate. As secondary outcome we want to investigate the effect of - short vs. long - oro-sensory exposure combined with a gastric load - low vs. high in energy -, on subjective feelings of satiety.
This is a randomized, cross over, single centre, trial with 5 treatments and a wash out period of at least 5 days in between test sessions. Subjects will have a naso-gastric tube inserted in all 5 treatments.
Number of subjects:
Twenty-seven men will be enrolled. With an expected drop-out rate of approximately 10% we will end up with 24 subjects.
Healthy men: aged 18-40 year, BMI 18.5-25 kg/m2, stable body weight, and who tolerate the treatments.
Rate of gastric emptying and subjective feelings of satiety.
|- Main changes (audit trail)|
|- RECORD||31-aug-2012 - 20-jan-2013|