Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients
This study is currently recruiting participants.
Verified September 2012 by Nestlé
Sponsor:
Nestlé
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01727583
First received: November 12, 2012
Last updated: November 15, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Healthy |
Dietary Supplement: meal intake Dietary Supplement: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
| Official Title: | Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients |
Further study details as provided by Nestlé:
Primary Outcome Measures:
- GLP-2 and GLP-1 kinetics [ Time Frame: changes from baseline to 4 hours following meal intake ] [ Designated as safety issue: No ]GLP-2 and GLP-1 are measured using Elisa
Secondary Outcome Measures:
- Intestinal and metabolic hormones [ Time Frame: Changes from baseline to 4 hours following meal intake ] [ Designated as safety issue: No ]Those hormones will be measured based on enzymatic technics
| Estimated Enrollment: | 18 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Lipid 1
Meal intake
|
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition
|
|
Placebo Comparator: Lipid-free
Maltodextrine + proteins
|
Dietary Supplement: Placebo |
|
Active Comparator: Lipid 2
Meal intake
|
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition
|
|
Active Comparator: Lipid 3
Meal intake
|
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition
|
|
Active Comparator: Lipid 4
meal intake
|
Dietary Supplement: meal intake
Intake of meals characterized by lipid composition
|
Detailed Description:
In this study, the investigators aim to investigate the effect of various lipid types on GLP-2 and GLP-1 secretion. This will allow to determine the importance of lipids in nutritional solutions. Moreover, this will allow us to assess whether existing clinical formulas can be improved in order to stimulate GLP-2 and accelerate intestinal recovery.
Eligibility| Ages Eligible for Study: | 20 Years to 40 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- BMI : 19 - 24.9 kg.m-2
- Normal fasting glycemia
- Having obtained his informed consent.
Exclusion Criteria:
- 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.
- Volunteer who cannot be expected to comply with the protocol, including consuming rapidly the study products, chronic medication intake
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01727583
Contacts
| Contact: Maurice Beaumont, MD | +41217858054 | maurice.beaumont@rdls.nestle.com |
| Contact: Frederik Delodder | +41217858965 | frederik.delodder@rdls.nestle.com |
Locations
| Switzerland | |
| Nestlé CDU / Metabolic Unit | Recruiting |
| Lausanne, Switzerland, 1000 | |
| Contact: Maurice Beaumont, MD +41217858054 maurice.beaumont@rdls.nestle.com | |
| Contact: Frederik Delodder +41217858965 frederik.delodder@rdls.nestle.com | |
| Principal Investigator: Maurice Beaumont, MD | |
Sponsors and Collaborators
Nestlé
Investigators
| Principal Investigator: | Maurice Beaumont, MD | Nestlé / CDU / Metabolic Unit |
More Information
No publications provided
| Responsible Party: | Nestlé |
| ClinicalTrials.gov Identifier: | NCT01727583 History of Changes |
| Other Study ID Numbers: | 12.10.MET |
| Study First Received: | November 12, 2012 |
| Last Updated: | November 15, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by Nestlé:
|
Healthy |
Additional relevant MeSH terms:
|
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013