Protein Hydrolyzation and Glycemic Control

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01034618
First received: December 16, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  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 Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: The Additional Effects of Protein Hydrolysate Supplementation on Glucose Homeostasis in Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Glucose and insulin homeostasis. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma amino acid profiles [ Designated as safety issue: No ]

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

Ages Eligible for Study:   40 Years to 70 Years
Genders 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01034618

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

No publications provided

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
Study First Received: December 16, 2009
Last Updated: December 16, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 23, 2014