Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning

This study has been completed.
Sponsor:
Collaborator:
Nederlandse Zuivel Organisatie
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01034241
First received: December 16, 2009
Last updated: July 22, 2010
Last verified: July 2010
  Purpose

The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.


Condition Intervention
Insulin
Glucose Metabolism
Dietary Supplement: Control
Dietary Supplement: High dairy protein
Dietary Supplement: vegetable protein
Dietary Supplement: High GI

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Glucose and insulin metabolism (24 h) [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Substrate partitioning and metabolic markers [ Time Frame: 24 h ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: April 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Diet consists of 15% dairy protein and low Glycemic Index (GI < 40), 55 En% carbohydrates and 30 En% fat
Dietary Supplement: Control
Diet consists of 15 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
Experimental: High dairy protein
Diet consists of 25% dairy protein and low GI (GI < 40), 45 En% carbohydrates and 30 En% fat
Dietary Supplement: High dairy protein
Diet consists of 25 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
Experimental: vegetable protein
Diet consists of 15 En% vegetable protein and low GI (GI < 40), 55 En% carbohydrates and 30 En% fat
Dietary Supplement: vegetable protein
Diet consists of 15 En% vegetable protein and low GI, 55 En% carbohydrates and 30 En% fat
Experimental: High GI
Diet consists of 15 En% dairy protein and high GI(GI > 60, 55 En% carbohydrates and 30 En% fat
Dietary Supplement: High GI
Diet consists of 15 En% dairy protein and high GI, 55 En% carbohydrates and 30 En% fat

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI: 18.5-25 kg/m2 (lean)
  • Gender: Male
  • Age: <35 years
  • Caucasian

Exclusion Criteria:

  • Elevated fasting blood glucose level
  • Lactose intolerant
  • Diabetes Mellitus
  • Hypertension (systolic/diastolic blood pressure)
  • Hypotension (systolic/diastolic blood pressure)
  • Cardiovascular diseases
  • Asthma and other obstructive pulmonary diseases
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01034241

Sponsors and Collaborators
Maastricht University Medical Center
Nederlandse Zuivel Organisatie
Investigators
Principal Investigator: Wim Saris, Prof. Dr. Maastricht University
  More Information

No publications provided

Responsible Party: Prof. dr. WHM Saris, University of Maastricht
ClinicalTrials.gov Identifier: NCT01034241     History of Changes
Other Study ID Numbers: MEC 08-3-072
Study First Received: December 16, 2009
Last Updated: July 22, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
milk protein
overweight
insulin metabolism
substrate partitioning

Additional relevant MeSH terms:
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014