CLA and Vitamin D on Protein Turnover

NCT ID: NCT03115775

Last Updated: 2019-11-21

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

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-05-12

Study Completion Date

2019-08-31

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.

Detailed Description

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Conditions

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Protein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, controlled clinical trial
Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Conjugated linoleic acid (Tonalin)

Conjugated linoleic acid (4000 mg Tonalin FFA 80 per day)

Group Type ACTIVE_COMPARATOR

Conjugated linoleic acid

Intervention Type DIETARY_SUPPLEMENT

Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) daily.

Vitamin D

Vitamin D3 (2000 IU per day)

Group Type ACTIVE_COMPARATOR

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Intervention will last up to 8 weeks. Subjects will receive vitamin D3 (2000 IU) daily.

Conjugated linoleic acid and Vitamin D

Conjugated linoleic acid (4000 mg Tonalin FFA 80) and Vitamin D (2000 IU) per day

Group Type ACTIVE_COMPARATOR

Conjugated linoleic acid and Vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Corn oil (4000 mg per day)

Group Type PLACEBO_COMPARATOR

Corn oil (placebo)

Intervention Type OTHER

Intervention will last up to 8 weeks. Subjects will receive corn oil (4000 mg) daily.

Interventions

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Conjugated linoleic acid

Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) daily.

Intervention Type DIETARY_SUPPLEMENT

Vitamin D

Intervention will last up to 8 weeks. Subjects will receive vitamin D3 (2000 IU) daily.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Corn oil (placebo)

Intervention will last up to 8 weeks. Subjects will receive corn oil (4000 mg) daily.

Intervention Type OTHER

Other Intervention Names

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Tonalin

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Diabetes
* COPD
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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BASF

INDUSTRY

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bettina Mittendorfer, PhD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University

St Louis, Missouri, United States

Site Status

Countries

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United States

References

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van Vliet S, Fappi A, Reeds DN, Mittendorfer B. No independent or combined effects of vitamin D and conjugated linoleic acids on muscle protein synthesis in older adults: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2020 Nov 11;112(5):1382-1389. doi: 10.1093/ajcn/nqaa240.

Reference Type DERIVED
PMID: 32860399 (View on PubMed)

Other Identifiers

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201702113

Identifier Type: -

Identifier Source: org_study_id

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