Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients

Healthy Clinical Trial

Official title:

Boosting the Secretion of GLP-2 and GLP-1 Intestinal Hormones by Nutrients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01727583
• Other study ID #: 12.10.MET
• Status: Completed
• Phase: N/A
• First received: November 12, 2012
• Last updated: November 7, 2013
• Start date: September 2012
• Est. completion date: November 2013

Study information

• Verified date: November 2013
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• meal intake
Intake of meals characterized by lipid composition
• Placebo

Locations

Country	Name	City	State
Switzerland	Nestlé CDU / Metabolic Unit	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GLP-2 and GLP-1 kinetics	GLP-2 and GLP-1 are measured using Elisa	changes from baseline to 4 hours following meal intake	No
Secondary	Intestinal and metabolic hormones	Those hormones will be measured based on enzymatic technics	Changes from baseline to 4 hours following meal intake	No