The Effects Potato Protein on Rates of Myofibrillar Muscle Protein Synthesis in Young Women

NCT ID: NCT04302038

Last Updated: 2020-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-01

Study Completion Date

2019-06-06

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will investigate the effects of potato protein on muscle protein synthesis over a short-term (a few hours after eating) and longer term (after two weeks of unilateral resistance exercise). Young women will be randomized to received potato protein supplementation or placebo in addition to their usual diet. Muscle biopsies will be taken and the participants will drink doubly labelled water to allow for the measurement of protein synthesis over time.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Muscle Protein Synthesis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group, single blind, randomized controlled trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants
Potato protein will be provided pre-mixed into prepared pudding. The control group will receive pudding without protein.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Protein

Intervention Type DIETARY_SUPPLEMENT

Additional daily protein provided by potato protein.

Control group

This group will consume protein from food sources set at 0.8 /kg/day including 2 pudding placebo cups per day.

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DIETARY_SUPPLEMENT

No additional dietary protein (outside of 0.8 g/kg/day as provided by diet)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Protein

Additional daily protein provided by potato protein.

Intervention Type DIETARY_SUPPLEMENT

Placebo control

No additional dietary protein (outside of 0.8 g/kg/day as provided by diet)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

McMaster University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Stuart Phillips

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ivor Wynne Centre

Hamilton, Ca-on, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HIREB 4969

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Anabolic Properties of Canola
NCT05664269 UNKNOWN NA