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

• Sponsor: PepsiCo Global R&D (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02282566
• Collaborator: (none)
• Enrollment: 48
• Location: 1
• Arms: 4
• Actual Duration (Months): 26.7
• Patients Per Site Per Month: 1.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Muscle Protein Synthesis	Other: Protein-nutrition beverage	N/A

Detailed Description

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Basic Science
• Official Title: A Pilot Trial to Assess the Effect of a Protein-Nutrition Beverage on Skeletal Muscle Protein Synthesis in Women
• Actual Study Start Date: Jan 6, 2015
• Actual Primary Completion Date: Mar 30, 2017
• Actual Study Completion Date: Mar 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Protein-nutrition beverage - Placebo : 8 oz protein-nutrition beverage 1	Other: Protein-nutrition beverage; Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter
Experimental: Protein-nutrition beverage - Beverage 2 8 oz protein-nutrition beverage 2	Other: Protein-nutrition beverage; Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter
Experimental: Protein-nutrition beverage - Beverage 3 8 oz protein-nutrition beverage 3	Other: Protein-nutrition beverage; Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter
Experimental: Protein-nutrition beverage - Beverage 4 8 oz protein-nutrition beverage 4	Other: Protein-nutrition beverage; Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter

Outcome Measures

Primary Outcome Measures

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 [0-3 hours post consumption and 5 days post consumptions]

Secondary Outcome Measures

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 [0-3 hours post consumption and 5 days post consumptions]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	McMaster University	Hamilton	Ontario	Canada	L8S 4L8

Sponsors and Collaborators

• PepsiCo Global R&D

Investigators

• Principal Investigator: Stuart Philips, PhD, McMaster University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: PepsiCo Global R&D
• ClinicalTrials.gov Identifier: NCT02282566
• Other Study ID Numbers: PEP-1331
• First Posted: Nov 4, 2014
• Last Update Posted: Mar 10, 2021
• Last Verified: Mar 1, 2021

• Keywords provided by PepsiCo Global R&D: Muscle protein synthesis

Study Results

No Results Posted as of Mar 10, 2021