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The effect of intraileal infusion of fat emulsions, differing in degree of saturation, on satiety and food intake after a liquid meal replacement.

The effect of intraileal infusion of fat emulsions, differing in degree of saturation, on satiety and food intake after a liquid meal replacement.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23841
Enrollment
15
Registered
2005-09-15
Start date
2005-09-26
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity.

Interventions

Saline (control) or a 5 g emulsion consisting either of mainly unsaturated fats (18:0), mono-unsaturated fat (18:1) or di-unsaturated fat (18:2) will be administered to the ileum on 4 consecutive days

Sponsors

LUMC - Dept of Gastroenterology - Hepatology PO box 9600 2300 RC Leiden fax nr.:0715248115 tel. nr.:0715263507
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Signed informed consent form; 2. Sex: male or female; 3. Age: 18-55 years; 4. Body Mass Index (BMI): 18-32 kg/m2.

Exclusion criteria

Exclusion criteria: 1. 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 or 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.

Design outcomes

Primary

MeasureTime frame
To assess whether emulsions differing in degree of saturation, have different effects when administered in the ileum, on satiety as measured by visual analogue scales, and food intake during ad libitum lunch.

Secondary

MeasureTime frame
To assess the effect of emulsions differing in degree of saturation, when infused in the ileum on gastric emptying, intestinal transit time and on secretion of peptides known to affect satiety. Peptides we will measure are Ghrelin and CCK as proximal gut hormones and Apo A-IV and PYY as distal gut hormones (ileal brake).

Contacts

Public ContactP.W.J. Maljaars

University Hospital Maastricht (azM) Department of Internal Medicine Divison of Gastroenterology & Hepatology PO Box 5800

PWJ.Maljaars@INTMED.unimaas.nl+31 (0)43 3882983

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)