NCT01847261

Brief Summary

During aging there is a tendency for muscle protein synthesis (growth) to become less efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can affect strength and mobility. Protein consumption may be one opportunity to alleviate this problem especially when consumed in appropriate amounts following resistance training. This study is designed to determine if a soy dairy protein blend, shown to be effective in younger adults, will produce beneficial muscle protein synthesis in older healthy adults following resistance exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

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

Study Start

First participant enrolled

April 1, 2013

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 6, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

October 7, 2019

Status Verified

October 1, 2019

Enrollment Period

1.6 years

First QC Date

April 24, 2013

Last Update Submit

October 3, 2019

Conditions

Muscle Synthesis

Keywords

soywheymuscleoldermTORsarcopenia

Outcome Measures

Primary Outcomes (1)

  • Fractional Synthetic Rate (Muscle Protein Synthesis)

    The fractional synthesis rate (FSR) of mixed muscle proteins will be calculated from the incorporation rate of L-\[ring-13C6\]Phenylalanine into the mixed muscle proteins, and the free-tissue phenylalanine enrichment.

    baseline, 3 hrs, 5 hrs

Secondary Outcomes (2)

  • Anti-inflammatory and Anti-oxidant Markers

    baseline, 3 hrs, 5 hrs

  • Intracellular Signalling Genes and Proteins

    baseline, 3 hrs, 5 hrs

Study Arms (2)

Soy Dairy Protein Blend

EXPERIMENTAL

30 grams of Soy Dairy Protein Blend given as a single beverage following leg resistance exercise

Dietary Supplement: Soy Dairy Protein Blend

Positive Control (Dairy Whey Protein)

ACTIVE COMPARATOR

30 grams of Dairy Whey Protein will be given as a single beverage following leg resistance exercise

Dietary Supplement: Positive Control (Dairy Whey Protein)

Interventions

Soy Dairy Protein BlendDIETARY_SUPPLEMENT
Soy Dairy Protein Blend
Positive Control (Dairy Whey Protein)DIETARY_SUPPLEMENT
Positive Control (Dairy Whey Protein)

Eligibility Criteria

Age55 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • yr olds Stable Body weight

You may not qualify if:

  • Exercise training (\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)
  • Significant heart, liver, kidney, blood, respiratory disease or thyroid issues
  • Peripheral vascular disease
  • Orthopedic injury that prohibits participation in the exercise training
  • Diabetes mellitus or other untreated endocrine disease
  • Active cancer (all groups) and history of cancer
  • Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)
  • Neurologic Injury or disease
  • Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
  • Alcohol or drug abuse
  • Tobacco use (smoking or chewing)
  • Malnutrition (BMI \< 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)
  • Obesity (BMI \> 30 kg/m2)
  • Low hemoglobin levels (below normal values)
  • Food allergies
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

Related Publications (1)

  • Borack MS, Reidy PT, Husaini SH, Markofski MM, Deer RR, Richison AB, Lambert BS, Cope MB, Mukherjea R, Jennings K, Volpi E, Rasmussen BB. Soy-Dairy Protein Blend or Whey Protein Isolate Ingestion Induces Similar Postexercise Muscle Mechanistic Target of Rapamycin Complex 1 Signaling and Protein Synthesis Responses in Older Men. J Nutr. 2016 Dec;146(12):2468-2475. doi: 10.3945/jn.116.231159. Epub 2016 Oct 26.

    PMID: 27798330DERIVED

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Blake Rasmussen, PhD

    University of Texas

    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
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2013

First Posted

May 6, 2013

Study Start

April 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

October 7, 2019

Record last verified: 2019-10

Locations

US(1)