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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 March 2021
• Main ID: NCT02282566
• Date of registration: 30/10/2014
• Prospective Registration: Yes
• Primary sponsor: PepsiCo Global R&D
• Public title: Effect of Protein-nutrition Beverages on Muscle Protein Synthesis in Women
• Scientific title: A Pilot Trial to Assess the Effect of a Protein-Nutrition Beverage on Skeletal Muscle Protein Synthesis in Women
• Date of first enrolment: January 6, 2015
• Target sample size: 48
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02282566
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Canada

Contacts

• Name: Stuart Philips, PhD
• Affiliation: McMaster University

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Older women, 65 to 75 years of age

2. At least 5 years post-menopausal

3. Body mass index (BMI) 20.00-29.99 kg/m2

4. Maintenance of habitual diet, physical activity patterns, and body weight throughout
the trial

5. Low to moderate habitual physical activity ( > 3500 but < 10,000 steps/d, no
structured activity)

6. 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])

7. 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.

8. Participant can consume a protein drink in the allotted time frame of 10 minutes

Exclusion Criteria:

1. 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.

2. Vegan

3. Smoker

4. Overt osteoporosis and/or osteopenia and/or sarcopenia as determined by DXA

5. High physical activity or participating in regular structured exercise (> 10,000
steps/d)

6. History of allergy, sensitivity, or strong dislike towards any of the components of
the study products (dairy protein)

7. Use of an investigational drug product within the last 30 days

8. Having participated in an another infusion protocol in the past year

9. 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

10. Subject does not understand English



Age minimum: 65 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Muscle Protein Synthesis

Intervention(s)

Other: Protein-nutrition beverage

Primary Outcome(s)

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 Outcome(s)

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]

Secondary ID(s)

PEP-1331

Source(s) of Monetary Support

Please refer to primary and secondary sponsors