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CLA and Vitamin D on Protein Turnover (TM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03115775
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : November 21, 2019
Sponsor:
Collaborator:
BASF
Information provided by (Responsible Party):
Washington University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Protein Dietary Supplement: Conjugated linoleic acid Dietary Supplement: Vitamin D Dietary Supplement: Conjugated linoleic acid and Vitamin D Other: Corn oil (placebo) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, controlled clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
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
Actual Study Start Date : May 12, 2017
Actual Primary Completion Date : August 31, 2019
Actual Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D

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 Name: 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.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetes
  • COPD

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115775


Locations
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United States, Missouri
Washington University
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
BASF
Investigators
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Principal Investigator: Bettina Mittendorfer, PhD Washington University School of Medicine
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03115775    
Other Study ID Numbers: 201702113
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents