CLA and Vitamin D on Protein Turnover (TM)

November 20, 2019 updated by: Washington University School of Medicine

Randomized Controlled Trial to Evaluate the Independent and Combined Effects of Conjugated Linoleic Acids and Vitamin D on Muscle Protein Turnover in Older Adults

To conduct a randomized, double-blind, controlled clinical trial to determine the independent and combined effects of dietary conjugated linoleic acid (CLA) and vitamin D supplementation on anabolic signaling, the expression of growth regulatory factors, and muscle protein turnover in older adults.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years to 81 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI >/= 18.5 and </= 35.0
  • Serum 25OH-VitD3 < 35 ng/ml

Exclusion Criteria:

  • Diabetes
  • COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conjugated linoleic acid (Tonalin)
Conjugated linoleic acid (4000 mg Tonalin FFA 80 per day)
Dietary supplement: Conjugated linoleic acid
Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) daily.
Other Names:
  • Tonalin
Active Comparator: Vitamin D
Vitamin D3 (2000 IU per day)
Dietary supplement: Vitamin D
Intervention will last up to 8 weeks. Subjects will receive vitamin D3 (2000 IU) daily.
Active Comparator: Conjugated linoleic acid and Vitamin D
Conjugated linoleic acid (4000 mg Tonalin FFA 80) and Vitamin D (2000 IU) per day
Dietary supplement: Conjugated linoleic acid and Vitamin D
Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) and vitamin D3 (2000 IU) daily.
Placebo Comparator: Placebo
Corn oil (4000 mg per day)
Other: Corn oil (placebo)
Intervention will last up to 8 weeks. Subjects will receive corn oil (4000 mg) daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in post-absorptive muscle protein synthesis
Time Frame: Baseline and 8 weeks
A stable isotope labelled amino acid infusion, in conjunction with blood and muscle tissue sampling and mathematical modelling analysis will be used to measure post-absorptive muscle protein synthesis.
Baseline and 8 weeks
Change in combined amino acid and insulin stimulated muscle protein synthesis
Time Frame: Baseline and 8 weeks
A stable isotope labelled amino acid infusion, in conjunction with insulin and mixed amino acid infusion, blood and muscle tissue sampling and mathematical modelling analysis will be used to measure muscle protein synthesis.
Baseline and 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

BASF

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 12, 2017

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

April 7, 2017

First Submitted That Met QC Criteria

April 11, 2017

First Posted (Actual)

April 14, 2017

Study Record Updates

Last Update Posted (Actual)

November 21, 2019

Last Update Submitted That Met QC Criteria

November 20, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201702113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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