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 |
| Protocol serial number | NTR481 |
| Sponsor | Leiden University Medical Centre (LUMC) (Netherlands) |
| Funder | Unilever Health Institute (Netherlands) - Unilever Research Vlaardingen |
- 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
Scientific
Leiden University Medical Center
Department of Gastroenterology- Hepatology
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 5261104 |
|---|---|
| p.w.j.maljaars@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind placebo controlled crossover design |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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. |
| Completion date | 24/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 15 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 26/09/2005 |
| Date of final enrolment | 24/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
