NCT04302038

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2020

Completed
Last Updated

March 10, 2020

Status Verified

March 1, 2020

Enrollment Period

7 months

First QC Date

March 6, 2020

Last Update Submit

March 6, 2020

Conditions

Keywords

Potato ProteinMuscle protein synthesisYoung women

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis

    Myofibrillar protein synthesis via measurement of deuterated (doubly) labeled water

    17 days

Secondary Outcomes (1)

  • Protein expression

    17 days

Study Arms (2)

Potato protein

EXPERIMENTAL

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

Dietary Supplement: Protein

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo control

Interventions

ProteinDIETARY_SUPPLEMENT

Additional daily protein provided by potato protein.

Potato protein
Placebo controlDIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • meet the age requirements
  • Female sex

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ivor Wynne Centre

Hamilton, Ca-on, L8S 4K1, Canada

Location

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Potato protein will be provided pre-mixed into prepared pudding. The control group will receive pudding without protein.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel group, single blind, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 6, 2020

First Posted

March 10, 2020

Study Start

November 1, 2018

Primary Completion

June 6, 2019

Study Completion

June 6, 2019

Last Updated

March 10, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations