NCT00643773

Brief Summary

The purpose of this study is to determine whether long term leucine supplementation has a positive effect on body composition and muscle characteristics in elderly, type 2 diabetes patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 type-2-diabetes

Timeline
Completed

Started May 2008

Typical duration for phase_2 type-2-diabetes

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

First Submitted

Initial submission to the registry

March 20, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 26, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

1.6 years

First QC Date

March 20, 2008

Last Update Submit

August 25, 2011

Conditions

Type 2 Diabetes

Keywords

Elderly

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    1, 3, and 6 months

Secondary Outcomes (1)

  • Muscle characteristics

    1, 3, and 6 months

Study Arms (2)

A

EXPERIMENTAL

Leucine supplement

Dietary Supplement: Leucine

B

PLACEBO COMPARATOR

Wheat flour

Dietary Supplement: Wheat flour

Interventions

LeucineDIETARY_SUPPLEMENT

capsules are 0.5g, subjects take 5 capsules with every main meal for 6 months In total this is 15 capsules per day

A
Wheat flourDIETARY_SUPPLEMENT

Wheat flour

B

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetes

You may not qualify if:

  • Impaired renal or liver function
  • Cardiac disease
  • Subjects with metal implants
  • Hypertension
  • Diabetes complications
  • Exogenous insulin therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, 6229 ER, Netherlands

Location

Related Publications (1)

  • Leenders M, Verdijk LB, van der Hoeven L, van Kranenburg J, Hartgens F, Wodzig WK, Saris WH, van Loon LJ. Prolonged leucine supplementation does not augment muscle mass or affect glycemic control in elderly type 2 diabetic men. J Nutr. 2011 Jun;141(6):1070-6. doi: 10.3945/jn.111.138495. Epub 2011 Apr 27.

    PMID: 21525248DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

LeucineFlour

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Branched-ChainAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, EssentialFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Marika Leenders, MSc

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2008

First Posted

March 26, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2009

Study Completion

June 1, 2010

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

NL(1)