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

ISRCTN ISRCTN51742545
DOI https://doi.org/10.1186/ISRCTN51742545
Secondary identifying numbers NTR481
Submission date
27/01/2006
Registration date
27/01/2006
Last edited
25/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr P.W.J. Maljaars
Scientific

Leiden University Medical Center
Department of Gastroenterology- Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone +31 (0)71 5261104
Email p.w.j.maljaars@lumc.nl

Study information

Study designDouble blind placebo controlled crossover design
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeQuality of life
Scientific title
Study objectivesLong-chain triglyceride (LCT) emulsions with di-unsaturated fatty acids will lead to enhanced postprandial satiety and reduced energy intake in a subsequent meal, as compared to LCT emulsions with mono-unsaturated or saturated fatty acids.
Ethics approval(s)Received from local medical ethics committee
Health condition(s) or problem(s) studiedObesity, overweight (BMI greater than or equal to 25 kg/m^2)
InterventionSaline (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, using a 270 cm catheter.
Intervention typeOther
Primary outcome measureTo 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 outcome measuresTo 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).
Overall study start date26/09/2005
Completion date24/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants15
Key inclusion criteria1. Signed informed consent form
2. Sex: male or female
3. Age: 18 - 55 years
4. Body mass index (BMI): 18 - 32 kg/m^2
Key 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 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 antidepressants, narcotic analgesics, 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 enrolment
Date of first enrolment26/09/2005
Date of final enrolment24/12/2005

Locations

Countries of recruitment

  • Netherlands

Study participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
Hospital/treatment centre

Department of Gastroenterology and Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website http://www.lumc.nl/
ROR logo "ROR" https://ror.org/027bh9e22

Funders

Funder type

Industry

Unilever Health Institute (Netherlands) - Unilever Research Vlaardingen

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/04/2009 Yes No