NCT03115775

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 14, 2017

Completed
28 days until next milestone

Study Start

First participant enrolled

May 12, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

April 7, 2017

Last Update Submit

November 20, 2019

Conditions

Protein

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (4)

Conjugated linoleic acid (Tonalin)

ACTIVE COMPARATOR

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

Dietary Supplement: Conjugated linoleic acid

Vitamin D

ACTIVE COMPARATOR

Vitamin D3 (2000 IU per day)

Dietary Supplement: Vitamin D

Conjugated linoleic acid and Vitamin D

ACTIVE COMPARATOR

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

Dietary Supplement: Conjugated linoleic acid and Vitamin D

Placebo

PLACEBO COMPARATOR

Corn oil (4000 mg per day)

Other: Corn oil (placebo)

Interventions

Conjugated linoleic acidDIETARY_SUPPLEMENT

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

Also known as: Tonalin
Conjugated linoleic acid (Tonalin)
Vitamin DDIETARY_SUPPLEMENT

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

Vitamin D
Conjugated linoleic acid and Vitamin DDIETARY_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.

Conjugated linoleic acid and Vitamin D
Corn oil (placebo)OTHER

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

Placebo

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diabetes
  • COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University

St Louis, Missouri, 63110, United States

Location

Related Publications (1)

  • 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.

    PMID: 32860399DERIVED

MeSH Terms

Interventions

Linoleic Acids, ConjugatedVitamin DCorn Oil

Intervention Hierarchy (Ancestors)

Linoleic AcidsFatty Acids, Omega-6Fatty Acids, UnsaturatedFatty AcidsLipidsSecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsDietary Fats, UnsaturatedDietary FatsFatsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bettina Mittendorfer, PhD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Randomized, double-blind, controlled clinical trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 14, 2017

Study Start

May 12, 2017

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

November 21, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)