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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19225118
Publication citations
-
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.