CLA and Vitamin D on Protein Turnover

Protein Clinical Trial

— TM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115775
• Other study ID #: 201702113
• Status: Completed
• Phase: N/A
• Start date: May 12, 2017
• Est. completion date: August 31, 2019

Study information

• Verified date: November 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• BMI >/= 18.5 and </= 35.0

• Serum 25OH-VitD3 < 35 ng/ml

Exclusion Criteria:

• Diabetes

• COPD

Related Conditions & MeSH terms

• Protein

Intervention

Dietary Supplement:
• Conjugated linoleic acid
Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) daily.
• Vitamin D
Intervention will last up to 8 weeks. Subjects will receive vitamin D3 (2000 IU) daily.
• 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.

Other:
• Corn oil (placebo)
Intervention will last up to 8 weeks. Subjects will receive corn oil (4000 mg) daily.

Locations

Country	Name	City	State
United States	Washington University	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	BASF

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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