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Protein Hydrolyzation and Glycemic Control

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01034618
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Maastricht University Medical Center
  Purpose
The insulinotropic effects of protein hydrolysate/amino acid ingestion have been shown to regulate blood glucose homeostasis in both type 2 diabetes patients and normoglycemic controls. The objective of the study is to investigate the optimal dose of such an insulinotropic mixture.

Condition Intervention
Diabetes Dietary Supplement: Protein hydrolyzation

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Glucose and insulin homeostasis.

Secondary Outcome Measures:
  • Plasma amino acid profiles

Study Start Date: December 2007
Study Completion Date: April 2009
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dietary Supplement: Protein hydrolyzation
Experimental: Intact protein Dietary Supplement: Protein hydrolyzation
Experimental: Protein hydrolysate Dietary Supplement: Protein hydrolyzation

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male
  • Age between 40 and 70 years
  • Oral blood glucose lowering medication
  • BMI < 35 kg/m2

Exclusion Criteria:

  • Exogenous insulin use
  • Cardiac disease (any cardiac event in the last 5 years)
  • Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio >2,5)
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01034618


Locations
Netherlands
Maastricht University Medical Center+
Maastricht, Limburg, Netherlands, 6229ER
Sponsors and Collaborators
Maastricht University Medical Center
  More Information

Responsible Party: Ralph J.F. Manders, PhD, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01034618     History of Changes
Other Study ID Numbers: 06-3-081
First Submitted: December 16, 2009
First Posted: December 17, 2009
Last Update Posted: December 17, 2009
Last Verified: December 2009

Keywords provided by Maastricht University Medical Center:
Diabetes
protein
protein hydrolysate