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OpenTrials
Completed

NCT Number: NCT02282566

Effect of Protein-nutrition Beverages on Muscle Protein Synthesis in Women

This study investigates whether a protein-nutrition beverage can increase muscle protein synthesis to a similar magnitude as a control beverage.

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Key information

Age range

65 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

About this study

Potential participants will be screened, and if eligible, invited to participate. Body composition and physical activity level will be assessed during the initiation visit. During the trial visits, women receive a protein-nutrition beverage; muscle protein synthesis is assessed via blood analytes and muscle biopsies at rest and after exercise. Statistical analysis includes mixed model regression approach with change in muscle protein synthesis as the primary outcome.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Older women, 65 to 75 years of age
  • At least 5 years post-menopausal
  • Body mass index (BMI) 20.00-29.99 kg/m2
  • Maintenance of habitual diet, physical activity patterns, and body weight throughout the trial
  • Low to moderate habitual physical activity ( > 3500 but < 10,000 steps/d, no structured activity)
  • In general good health (stage I hypertension allowed - 140/90) on the basis of medical history; and taking no medication other than anti-hypertensives, selective serotonin-reuptake inhibitors, and/or statins (excluding simvastatin [Zocor] and atorvastatin [Lipitor])
  • Participant understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.
  • Participant can consume a protein drink in the allotted time frame of 10 minutes

Exclusion criteria

  • History or presence of clinically important renal or gastrointestinal disorders, diabetes mellitus (glucose >126 mg/dL, fingerstick) or metabolic disease, unstable arrhythmia, angina, taking anti-diabetic, anti-inflammatory, platelet inhibitor, or anti-coagulant medications.
  • Vegan
  • Smoker
  • Overt osteoporosis and/or osteopenia and/or sarcopenia as determined by DXA
  • High physical activity or participating in regular structured exercise (> 10,000 steps/d)
  • History of allergy, sensitivity, or strong dislike towards any of the components of the study products (dairy protein)
  • Use of an investigational drug product within the last 30 days
  • Having participated in an another infusion protocol in the past year
  • Individual has a condition the PI believes would interfere with her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk
  • Subject does not understand English

Treatment and study plan

Protein-nutrition beverage

Other

Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter

Primary outcomes

  1. Change (timei -baseline) of muscle protein synthesis at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage

    Time frame: 0-3 hours post consumption and 5 days post consumptions

Secondary outcomes

  1. Change (timei -baseline) of blood sample analytes at rest and following exercise in response to the protein-nutrition beverages compared to a control beverage

    Time frame: 0-3 hours post consumption and 5 days post consumptions

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

A Pilot Trial to Assess the Effect of a Protein-Nutrition Beverage on Skeletal Muscle Protein Synthesis in Women

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 4, 2014
Registry last updated
Mar 10, 2021

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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