The Effect of Leucine on Body Composition and Muscle Characteristics in Elderly, Type 2 Diabetes Patients

NCT ID: NCT00643773

Last Updated: 2011-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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A

Leucine supplement

Group Type EXPERIMENTAL

Leucine

Intervention Type DIETARY_SUPPLEMENT

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

B

Wheat flour

Group Type PLACEBO_COMPARATOR

Wheat flour

Intervention Type DIETARY_SUPPLEMENT

Wheat flour

Interventions

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Leucine

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

Intervention Type DIETARY_SUPPLEMENT

Wheat flour

Wheat flour

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of type 2 diabetes

Exclusion Criteria

* Impaired renal or liver function
* Cardiac disease
* Subjects with metal implants
* Hypertension
* Diabetes complications
* Exogenous insulin therapy
Minimum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marika Leenders, MSc

Role: PRINCIPAL_INVESTIGATOR

Maastricht University

Locations

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Maastricht University

Maastricht, , Netherlands

Site Status

Countries

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Netherlands

References

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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.

Reference Type DERIVED
PMID: 21525248 (View on PubMed)

Other Identifiers

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MEC-07-1111

Identifier Type: -

Identifier Source: org_study_id

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