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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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013