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van CCT (UK)

van CCT (UK)

Influence of distribution of small intestinal delivery of fat on satiety and energy intake in healthy volunteers.

- candidate number4717
- NTR NumberNTR1584
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR11-dec-2008
- Secondary IDs0710  MEC 08-1-008
- Public TitleInfluence of distribution of small intestinal delivery of fat on satiety and energy intake in healthy volunteers.
- Scientific TitleInfluence of distribution of small intestinal delivery of fat on satiety and energy intake in healthy volunteers.
- hypothesisWe hypothesise that increasing the luminal surface exposed to the emulsion will lead to a decrease in hunger and food intake, but that otherwise, the ileal infusion will have the greatest impact on these parameters.
- Healt Condition(s) or Problem(s) studiedOverweight, Obesity, Weight
- Inclusion criteria1. Sex: male or female;
2. Age: 18-55 years;
3. Body mass index(BMI): 18-29 kg/m2.
- Exclusion criteria1. Evidence of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol;
2. Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit;
3. The use of psychotropic drugs, including: benzodiazepines. Alcohol in excess of 21 units/week for males and 14 units/week for females;
4. Concomitant medication that can increase gastric pH (e.g. antacids, protonpump-inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists), or alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepresants, narcotic analgetics, adrenergic agents, calcium channel blockers), or alter intestinal transit (e.g. loperamide, chemical/osmotic/bulk laxatives) ,or influence satiety/energy intake (e.g. sibutramine, glucocorticoids, anabolic steroids);
5. Intolerance of Slim Fast product or of ingredients of the ad libitum meal;
6. Pregnancy, lactation, wish to become pregnant during study, or having a positive pregnancy test at inclusion;
7. Reported unexplained weight loss/gain of more than 2 kg in the month before the study enrollment;
8. Eating disorders detected using the ˇ§SCOFFˇ¨ questionnaire (in Dutch translation), and high or very high-restrained eaters as measured by the Dutch Eating Behavior Questionnaire;
9. Blood donations less than three months previous to study enrollment;
10. One or more of the following dietary habits: medically prescribed diets, weight reduction diets, or vegetarian/macrobiotic/biologically dynamic food habits;
11. Reported working on late/night shifts.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate14-mrt-2008
- Target number of participants15
- InterventionsAfter intubation with a naso-ileal catheter, volunteers will three times receive an intra-intestinal infusion with a fat emulsion, and once a saline control.
- Primary outcomeThe main study parameters are differences in satiety scores (as measured by visual analogue scale (VAS)) per time point and as AUC and differences in food intake during an ad libitum meal.
- Secondary outcomeSecondary parameters are plasma concentrations of gut peptides and difference in gastric emptying T1/2 and small bowel transit time.
- Timepoints-15 min;
0 min;
30 min;
45 min;
60 min;
75 min;
90 min;
105 min;
120 min;
135 min;
150 min;
165 min;
180 min;
210 min.
- Trial web siteN/A
- statusstopped: trial finished
- Sponsor/Initiator University Hospital Maastricht (AZM), Department of Internal Medicine
- Funding
(Source(s) of Monetary or Material Support)
Unilever Research Vlaardingen, Unilever Health Institute
- PublicationsN/A
- Brief summaryReady-to-drink (RTD) meal replacements are effective in reducing body weight in people following an overall diet plan. However, feelings of hunger return already within two hours after ingestion of these drinks, and this may influence compliance to the diet plan.
In order to optimize the satiating potency of triacylglycerols, we previously performed a study in which we varied the location of fat infusion, showing that activation of the ileal brake by ileal fat infusion reduced food intake by an additional 12 % compared to the same emulsion infused in the duodenum, thereby demonstrating the potency of the ileal brake to reduce food intake and satiety.
In rats, another method of increasing the satiating potency of a meal is by increasing the spread of fat emulsion over the small intestinal surface.
In the present study we will test the optimal distribution of an emulsion in the small intestine infusion, in order to maximize the effect on satiety parameters and food intake during an ad libitum-lunch. Furthermore, we aim to compare whether in humans increasing the surface area of infusion leads to an increase in inhibition of hunger and food intake.
- Main changes (audit trail)
- RECORD11-dec-2008 - 12-jan-2009

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