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

A Pilot Trial to Assess the Effect of a Protein-Nutrition Beverage on Skeletal 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.

Study Overview

• Status: Completed
• Conditions: Muscle Protein Synthesis
• Intervention / Treatment: Other: Protein-nutrition beverage

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8S 4L8
      • McMaster University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Stuart Philips, PhD, McMaster University

Publications and helpful links

General Publications

• Devries MC, McGlory C, Bolster DR, Kamil A, Rahn M, Harkness L, Baker SK, Phillips SM. Leucine, Not Total Protein, Content of a Supplement Is the Primary Determinant of Muscle Protein Anabolic Responses in Healthy Older Women. J Nutr. 2018 Jul 1;148(7):1088-1095. doi: 10.1093/jn/nxy091. Erratum In: J Nutr. 2019 Mar 1;149(3):542.
• Devries MC, McGlory C, Bolster DR, Kamil A, Rahn M, Harkness L, Baker SK, Phillips SM. Protein leucine content is a determinant of shorter- and longer-term muscle protein synthetic responses at rest and following resistance exercise in healthy older women: a randomized, controlled trial. Am J Clin Nutr. 2018 Feb 1;107(2):217-226. doi: 10.1093/ajcn/nqx028.

Study record dates

Study Major Dates

• Study Start (Actual): January 6, 2015
• Primary Completion (Actual): March 30, 2017
• Study Completion (Actual): March 30, 2017

Study Registration Dates

• First Submitted: October 30, 2014
• First Submitted That Met QC Criteria: October 31, 2014
• First Posted (Estimate): November 4, 2014

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 8, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Muscle protein synthesis
• Other Study ID Numbers: PEP-1331