NCT04841772

Brief Summary

This study will allow researchers to explore how muscle responds to heavy exercise. The researchers will characterise rates of muscle protein breakdown and synthesis 24hours after heavy exercise with a post exercise protein polyphenol or placebo supplementation. This will inform strategies to help people recover from heavy exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

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

April 8, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 9, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

1.6 years

First QC Date

April 9, 2021

Last Update Submit

March 21, 2023

Conditions

Keywords

Skeletal musclePostabsorptiveMuscle protein breakdownMuscle protein synthesis

Outcome Measures

Primary Outcomes (1)

  • Muscle protein breakdown rate

    Muscle protein breakdown rate (FBR, measured in %/h) 24hours post eccentric exercise.

    1hour

Secondary Outcomes (1)

  • Muscle protein synthesis rate

    3hours

Study Arms (2)

Vegan Protein

ACTIVE COMPARATOR
Dietary Supplement: Recover Vegan Protein Supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Post exercise protein supplement (26g pea protein)

Vegan Protein
PlaceboDIETARY_SUPPLEMENT

Post exercise placebo supplement (32g maltodextrin)

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Recreationally active
  • years of age

You may not qualify if:

  • Regular and structured involvement in resistance training
  • Inactive participants
  • Habitual dietary protein intake \<0.8g/kg bw/day and \>2.0g/kg bw/day
  • Regular use of nutritional supplements known to suppress inflammation or modulate protein metabolism Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
  • Current musculoskeletal injury
  • Chronic use of anti-inflammatory medicines
  • Any known disorders in muscle metabolism
  • Individuals with an allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients
  • Allergy to lidocaine
  • Having received or ingested a stable isotope tracer containing 15N in the past
  • A personal or family history of epilepsy, seizures or schizophrenia
  • Stomach bleeding or stomach ulcer
  • Kidney failure
  • Liver problems, such as fibrosis, cirrhosis or failure
  • Crohns disease or ulcerative colitis
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2021

First Posted

April 12, 2021

Study Start

April 8, 2021

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations