- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04302038
The Effects Potato Protein on Rates of Myofibrillar Muscle Protein Synthesis in Young Women (APRE)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The loss of skeletal muscle mass and strength with advancing age, collectively termed sarcopenia, is a primary risk factor for disability, frailty, and premature mortality. This is especially true in women, where rapid rates of decline in muscle mass and greater anabolic resistance (blunting of muscle protein synthesis [MPS] despite availability of amino acids) are experienced around the time of menopause2. Previous evidence has demonstrated that resistance exercise is an effective strategy to mitigate muscle loss in older adults, particularly in conjunction with protein supplementation. Typically, animal-based proteins are utilized in research studies; however, they may be inaccessible for older women with limited financial income or simply unattractive to the growing number of women consuming more plant-based diets. While potatoes contain lower amounts of protein compared to animal sources, the high biological value (BV~90-100) of potato protein and high consumption rates, make this food an ideal source of protein in North American diets. In fact, potatoes contribute roughly 3%-3.5% of the total daily protein intake for adults and plant-based proteins contribute 60% of dietary protein worldwide. When compared to animal sourced protein, potatoes are readily available and are a highly sustainable food source. Consequently, potatoes represent an accessible, cost-effective protein source for the growing aging population. However, the efficacy of a diet rich in potato protein to stimulate an increase in integrated rates of MPS, which are the basis for muscle growth, in women has not been investigated. Therefore, while the eventual target consumer will be all women, young and old, firstly we will demonstrate the effectiveness of potato based protein to stimulate MPS in young women.
Twenty-four healthy young women (18-29 yrs) will be recruited to participate in this parallel group, double blind, randomized controlled trial. Participants will be randomized to either supplementary isolated potato protein and unilateral resistance training, or unilateral resistance training alone as placebo (with usual dietary practices, protein clamped at 0.8 g/kg/day). Participants will engage in unilateral resistance training 3 times per wk for 2 wk. To assess the anabolic properties of potato protein, the women in the potato protein group will ingest 25 g of isolated potato protein 2 times a day. On the day of resistance exercise one serving will be provided immediately after the cessation of training. The placebo group will follow the same supplement schedule, but with a placebo. Integrated rates of myofibrillar MPS will be assessed with the precursor-product method using deuterium labeled water (70% D2O).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ca-on
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Hamilton, Ca-on, Canada, L8S 4K1
- Ivor Wynne Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- meet the age requirements
- Female sex
Exclusion Criteria:
- Significant loss or gain of body mass in the past 6 months (>2 kg)
- Regular use of: non-steroidal anti-inflammatory drugs
- History of chronic disease
- Current or recently active or remised cancer
- Infectious disease; and/or gastrointestinal disease
- Consuming a vegetarian or vegan diet = Any condition or injury that would preclude them from participating in resistance exercise
Study Plan
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Potato protein
Participants will be provided with 25 g of potato protein twice per day in addition to a diet set at the recommended daily allowance.
Total protein intake for this group will be 1.6 g/kg/day
|
Additional daily protein provided by potato protein.
|
PLACEBO_COMPARATOR: Control group
This group will consume protein from food sources set at 0.8 /kg/day including 2 pudding placebo cups per day.
|
No additional dietary protein (outside of 0.8 g/kg/day as provided by diet)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein synthesis
Time Frame: 17 days
|
Myofibrillar protein synthesis via measurement of deuterated (doubly) labeled water
|
17 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Protein expression
Time Frame: 17 days
|
Western blot analysis to determine total protein expression of the proteins involved in the muscle protein synthesis pathway
|
17 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- HIREB 4969
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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