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Gut Hormone Secretion and Macronutrients

This study has been completed.
Sponsor:
Collaborator:
Centre Hospitalier Universitaire Vaudois
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne
ClinicalTrials.gov Identifier:
NCT00869453
First received: March 25, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy Volunteers
 Other: test meal
Other: glucose
Other: fat
Other: protein
Other: control

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Gut Hormone Secretion Pattern in Response to Different Macronutrients in Healthy Volunteers

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by University of Lausanne:

Primary Outcome Measures:
  • Gut hormone secretion [ Time Frame: within 4 hours following a test meal ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Entero-insular axis measurement [ Time Frame: within 4 hours following a test meal ] [ Designated as safety issue: No ]
  • Glucose turnover [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Insulin sensitivity [ Time Frame: 6 hours ] [ Designated as safety issue: No ]
  • Substrate oxidation [ Time Frame: 6 hours ] [ Designated as safety issue: No ]

Enrollment: 8
Study Start Date: March 2009
Study Completion Date: December 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Healthy volunteers
 Other: test meal
Mixed meal containing bread, butter, beef
Other: glucose
administration of a glucose meal
Other: fat
administration of a lipid meal
Other: protein
administration of a protein meal
Other: control
no meal

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy male volunteers

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869453

Locations
Switzerland
Cardiomet Clinical research Center, CHUV
Lausanne, VD, Switzerland, CH-1011
University of Lausanne
Lausanne, Switzerland, 1005
Sponsors and Collaborators
University of Lausanne
Centre Hospitalier Universitaire Vaudois
Investigators
Principal Investigator: Luc Tappy, MD Centre Hospitalier Universitaire Vaudois
  More Information

No publications provided by University of Lausanne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Luc Tappy, MD, professor of physiology, University of Lausanne
ClinicalTrials.gov Identifier: NCT00869453     History of Changes
Other Study ID Numbers: 162/08/CE/FBM
Study First Received: March 25, 2009
Last Updated: June 29, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University of Lausanne:
Gut hormone
hyperglycaemic clamp
glucose turnver

Additional relevant MeSH terms:
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013