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The effects of orally and intraduodenally administered pea protein on satiety parameters in vivo in lean and obese subjects


- candidate number3949
- NTR NumberNTR1437
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR9-sep-2008
- Secondary IDsMEC08-3-058 
- Public TitleThe effects of orally and intraduodenally administered pea protein on satiety parameters in vivo in lean and obese subjects
- Scientific TitleThe effects of orally and intraduodenally administered pea protein on satiety parameters in vivo in lean and obese subjects
- ACRONYMN/A
- hypothesisOur hypothesis is that administration of intact protein into the duodenum will be more satiating compared to oral administration.
- Healt Condition(s) or Problem(s) studiedObesity, Dietary proteins, Satiety
- Inclusion criteria1. Male, non smoking
2. Age between 18 and 65 years
3. Body Mass Index for lean subjects between 20 and 26 kg/m2
4. Body Mass Index for obese subjects between 30 and 37 kg/m2
5. No medication
6. No history of intestinal illness
7. Stable body weight over the last three months
8. No blood donation 2 months prior to the study and during the study
- Exclusion criteria1. Age under 18 and over 65 years
2. BMI under 20 and over 37 kg/m2
3. Medication or disease that could interfere with the results of the study, to be judged by the responsible medical doctor
4. Recent blood donation within 2 months prior to the start of the study
5. Intestinal illness at any time in the past
6. Female
7. Smokers
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2008
- planned closingdate1-nov-2010
- Target number of participants24
- InterventionsThis study is a randomized, placebo controlled cross-over study with 2 groups of volunteers. One group will consist of healthy lean male subjects. The other group will consist of obese male subjects.
All subjects will receive both the test protein and the placebo, administered either orally or intraduodenally, depending on the test day. Delievery of the protein and placebo into the duodenum will be through a feeding tube.

- Oral ingestion placebo
- Oral ingestion protein
- Duodenal administration placebo
- Duodenal administration protein

All conditions are randomized over 4 test days
- Gastroscopy on the 5h test day
- Primary outcomeThe effects of orally- and intraduodenally administered intact protein on systemic satiety hormone levels (CCK, GLP-1, and PYY) and feelings of hunger and satiety
- Secondary outcome- To investigate the differences in plasma hormone levels after protein exposure in lean vs. obese subjects
- To investigate whether duodenal protein supplementation reduces food intake compared to oral supplementation
- TimepointsAll subjects will visit the university on four occasions. On these test days, subjects will receive placebo or pea protein, either orally or intraduodenally. Two consecutive test sessions will be interspaced with a one-week washout period.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. M.C.P. Geraedts
- CONTACT for SCIENTIFIC QUERIESDr. Freddy J. Troost
- Sponsor/Initiator Transnational University Limburg
- Funding
(Source(s) of Monetary or Material Support)
Transnational University Limburg
- PublicationsN/A
- Brief summaryThis study will investigate the effects of different administration routes of pea protein on intestinal satiety hormone release, on plasma satiety hormone levels and on feelings of hunger and satiety.
This study is a randomized, placebo controlled cross-over study with 2 groups of volunteers. One group will consist of healthy lean male subjects. The other group will consist of obese male subjects.
All subjects will receive both pea protein and placebo, administered either orally or intraduodenally, depending on the test day.
All subjects will visit the university on four occasions. On these test days, subjects will receive placebo or pea protein, either orally or intraduodenally. Two consecutive test sessions will be interspaced with a one-week washout period. Blood samples will be collected during a 2h period, and a questionaire will be filled in by the subjects. Levels of CCK and GLP-1 will be measured in the bloodsamples.
- Main changes (audit trail)
- RECORD9-sep-2008 - 3-mrt-2009


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