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OpenTrials
Completed

NCT Number: NCT01847261

Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults

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.

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Key information

Conditions

Muscle Synthesis Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms

Age range

55 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

55-70 yr olds Stable Body weight

Exclusion criteria

  • 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
  • Taking dietary supplements such as green tea, omega 3 fatty acids, etc.
  • Females

Treatment and study plan

Soy Dairy Protein Blend

Dietary Supplement

Positive Control (Dairy Whey Protein)

Dietary Supplement

Primary outcomes

  1. Fractional Synthetic Rate (Muscle Protein Synthesis)

    Time frame: baseline, 3 hrs, 5 hrs

    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.

Secondary outcomes

  1. Anti-inflammatory and Anti-oxidant Markers

    Time frame: baseline, 3 hrs, 5 hrs

    Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx).

  2. Intracellular Signalling Genes and Proteins

    Time frame: baseline, 3 hrs, 5 hrs

    Phosphorylation of Mammalian Target of Rapamycin (mTOR) pathway will be measured using Western blot techniques

Sponsors and collaborators

Lead sponsor

DuPont Nutrition and Health

Industry

Registry information

Official study title

A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown in Healthy Older Adults

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 6, 2013
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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