Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients
1 other identifier
interventional
18
1 country
1
Brief Summary
This pilot study is aimed at assessing the acute effect of several combinations of lipids differing in their fatty acid composition on glucagon-like-peptide (GLP)-2 and GLP-1 secretion in healthy subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Sep 2012
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 12, 2012
CompletedFirst Posted
Study publicly available on registry
November 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedNovember 8, 2013
November 1, 2013
1.1 years
November 12, 2012
November 7, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
GLP-2 and GLP-1 kinetics
GLP-2 and GLP-1 are measured using Elisa
changes from baseline to 4 hours following meal intake
Secondary Outcomes (1)
Intestinal and metabolic hormones
Changes from baseline to 4 hours following meal intake
Study Arms (5)
Lipid 1
ACTIVE COMPARATORMeal intake
Lipid-free
PLACEBO COMPARATORMaltodextrine + proteins
Lipid 2
ACTIVE COMPARATORMeal intake
Lipid 3
ACTIVE COMPARATORMeal intake
Lipid 4
ACTIVE COMPARATORmeal intake
Interventions
Intake of meals characterized by lipid composition
Eligibility Criteria
You may qualify if:
- BMI : 19 - 24.9 kg.m-2
- Normal fasting glycemia
- Having obtained his informed consent.
You may not qualify if:
- Gastro-intestinal disease (ulcer), pancreatic disease, hepatic disease, metabolic diseases / disorders (diabetes, dyslipidemia), renal disease, cardiovascular disease (arterial hypertension), as determined by the medical screening visit and a blood analysis.
- Have had a gastrointestinal surgery (with the exception of appendices resection).
- Malabsorption disorders
- Lactose intolerance
- Significant weight loss during the past three months (more than 5% of initial weight)
- Have a regular consumption of medication
- Regular supplements (vitamins and minerals) intake during the previous month
- Have an alcohol intake: \> 2 units a day
- Smoker (more than 2 cigarettes a day)
- Illicit substances intake, as stated on the medical screening questionnaire
- Allergy to any food or medication
- Anaemia defined by a number of erythrocytes or hemoglobin Hb or hematocrit Ht which are inferior to laboratory normal ranges
- Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study
- Intense physical activity \> 3 hours per week
- Currently participating or having participated in another clinical trial during the past month.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nestlé CDU / Metabolic Unit
Lausanne, 1000, Switzerland
Study Officials
- PRINCIPAL INVESTIGATOR
Maurice Beaumont, MD
Nestlé / CDU / Metabolic Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2012
First Posted
November 16, 2012
Study Start
September 1, 2012
Primary Completion
October 1, 2013
Study Completion
November 1, 2013
Last Updated
November 8, 2013
Record last verified: 2013-11