NCT01034618

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2009

Completed
Last Updated

December 17, 2009

Status Verified

December 1, 2009

Enrollment Period

10 months

First QC Date

December 16, 2009

Last Update Submit

December 16, 2009

Conditions

Diabetes

Keywords

Diabetesproteinprotein hydrolysate

Outcome Measures

Primary Outcomes (1)

  • Glucose and insulin homeostasis.

Secondary Outcomes (1)

  • Plasma amino acid profiles

Study Arms (3)

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Protein hydrolyzation

Intact protein

EXPERIMENTAL
Dietary Supplement: Protein hydrolyzation

Protein hydrolysate

EXPERIMENTAL
Dietary Supplement: Protein hydrolyzation

Interventions

Protein hydrolyzationDIETARY_SUPPLEMENT
Intact proteinPlaceboProtein hydrolysate

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Exogenous insulin use
  • Cardiac disease (any cardiac event in the last 5 years)
  • Diabetic complications (microvascular complications, microalbuminuria: albumin:creatinine ratio \>2,5)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center+

Maastricht, Limburg, 6229ER, Netherlands

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 16, 2009

First Posted

December 17, 2009

Study Start

December 1, 2007

Primary Completion

October 1, 2008

Study Completion

April 1, 2009

Last Updated

December 17, 2009

Record last verified: 2009-12

Locations

NL(1)