CLA and Vitamin D on Protein Turnover

Study Overview
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Brief Summary
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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.

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

Conditions
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Protein

Intervention / Treatment
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* Dietary Supplement: Conjugated linoleic acid
* Dietary Supplement: Vitamin D
* Dietary Supplement: Conjugated linoleic acid and Vitamin D
* Other: Corn oil (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI >/= 18.5 and </= 35.0 Serum 25OH-VitD3 < 35 ng/ml Exclusion Criteria: Diabetes COPD

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, controlled clinical trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conjugated linoleic acid (Tonalin)<br>Conjugated linoleic acid (4000 mg Tonalin FFA 80 per day) | Dietary Supplement: Conjugated linoleic acid<br>* Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) daily.<br>* Other names: Tonalin;|
| Active Comparator: Vitamin D<br>Vitamin D3 (2000 IU per day) | Dietary Supplement: Vitamin D<br>* Intervention will last up to 8 weeks. Subjects will receive vitamin D3 (2000 IU) daily.<br>|
| Active Comparator: Conjugated linoleic acid and Vitamin D<br>Conjugated linoleic acid (4000 mg Tonalin FFA 80) and Vitamin D (2000 IU) per day | Dietary Supplement: Conjugated linoleic acid and Vitamin D<br>* Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) and vitamin D3 (2000 IU) daily.<br>|
| Placebo Comparator: Placebo<br>Corn oil (4000 mg per day) | Other: Corn oil (placebo)<br>* Intervention will last up to 8 weeks. Subjects will receive corn oil (4000 mg) daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in post-absorptive muscle protein synthesis | 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 | 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 |