Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
25/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr P.W.J. Maljaars

ORCID ID

Contact details

Leiden University Medical Center
Department of Gastroenterology- Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5261104
p.w.j.maljaars@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR481

Study information

Scientific title

Acronym

Study hypothesis

Long-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

Received from local medical ethics committee

Study design

Double blind placebo controlled crossover design

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet

Condition

Obesity, overweight (BMI greater than or equal to 25 kg/m^2)

Intervention

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, using a 270 cm catheter.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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 outcome measures

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).

Overall trial start date

26/09/2005

Overall trial end date

24/12/2005

Reason abandoned

Eligibility

Participant 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/m^2

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

15

Participant 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 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

Recruitment start date

26/09/2005

Recruitment end date

24/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Centre (LUMC) (Netherlands)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.lumc.nl/

Funders

Funder type

Industry

Funder name

Unilever Health Institute (Netherlands) - Unilever Research Vlaardingen

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19225118

Publication citations

  1. Results

    Maljaars J, Romeyn EA, Haddeman E, Peters HP, Masclee AA, Effect of fat saturation on satiety, hormone release, and food intake., Am. J. Clin. Nutr., 2009, 89, 4, 1019-1024, doi: 10.3945/ajcn.2008.27335.

Additional files

Editorial Notes