Gut Hormone Secretion and Macronutrients

Healthy Volunteers Clinical Trial

Official title:

Gut Hormone Secretion Pattern in Response to Different Macronutrients in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869453
• Other study ID #: 162/08/CE/FBM
• Status: Completed
• Phase: N/A
• First received: March 25, 2009
• Last updated: June 29, 2012
• Start date: March 2009
• Est. completion date: December 2009

Study information

• Verified date: June 2012
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational

Clinical Trial Summary

The role of gut hormone (GLP-1, GIP, PYY...) in glucose homeostasis has been widely demonstrated. Furthermore modifications in their pattern of secretion seem to be involved in the improvement of glucose control in obese patients after bariatric surgery.

The purpose of this study is to assess the respective role of carbohydrate, fat and protein from a complete meal in gut hormones secretion.

Description:

The study is designed to asses the role of each individual macronutrient of a compete meal in gut hormones secretion in healthy volunteers.

8 healthy young male subjects will be studied on 5 different occasions. To asses the role of each macronutient the subjects will recieve one of the following test meal: a complete sandwich, the proteic part of this complete meal, the glucidic part and the lipidic part. The fifth test will be a fasting test.

To assess the entero-insular axis, a 5.5 hours hyperglycaemic clamp will be performed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

Inclusion Criteria:

• Male

• 18-35 years old

• 19 kg/m2 = BMI = 25 kg/m2

• Healthy

• Low to moderate physical activity

• Non smokers

Exclusion Criteria:

• Family history of diabetes mellitus

• Any medication

• Participation to blood spending or other clinical study in the 3 months before the beginning of this study

• Consumption of drugs

• Consumption of more than 50g of alcool in a week

• Vegetarian or particular diet

• Anamnèse d'intolérance alimentaire

• Family history of food intolerance

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• test meal
Mixed meal containing bread, butter, beef
• glucose
administration of a glucose meal
• fat
administration of a lipid meal
• protein
administration of a protein meal
• control
no meal

Locations

Country	Name	City	State
Switzerland	Cardiomet Clinical research Center, CHUV	Lausanne	VD
Switzerland	University of Lausanne	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne	Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Gut hormone secretion		within 4 hours following a test meal	No
Secondary	Entero-insular axis measurement		within 4 hours following a test meal	No
Secondary	Glucose turnover		6 hours	No
Secondary	Insulin sensitivity		6 hours	No
Secondary	Substrate oxidation		6 hours	No