NCT04156386

Brief Summary

This study will assess the effect of daily post-exercise vegan (pea) and animal (whey) protein ingestion compared to placebo over 7 days of recovery from strenuous exercise. Muscle strength and soreness will be measured daily, and mechanisms underpinning recovery will be investigated in muscle biopsies taken 3, 24 and 48 hours after exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration 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

First Submitted

Initial submission to the registry

September 6, 2019

Completed
17 days until next milestone

Study Start

First participant enrolled

September 23, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 7, 2019

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2022

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.6 years

First QC Date

September 6, 2019

Last Update Submit

March 21, 2023

Conditions

Muscle Recovery

Keywords

Muscle StrengthMusculoskeletal PhysiologyMuscle, SkeletalWhey ProteinsPlant ProteinsDietary supplements

Outcome Measures

Primary Outcomes (1)

  • Change in isokinetic work (W30) performed before and every 24 h after performing 300 maximal eccentric quadriceps contractions.

    The recovery of skeletal muscle isokinetic force production following eccentric exercise using an isokinetic dynamometer

    Once per 24 hour period for 7 days

Secondary Outcomes (5)

  • Perceived quadriceps muscle soreness

    Once per 24 hour period for 7 days

  • Muscle swelling

    Once per 24 hour period for 3 days

  • Rate of protein incorporation into the muscle

    Once per 24 hour period for 3 days

  • Plasma creatine kinase (CK) activity before and every 24 h after performing 300 maximal eccentric quadriceps contractions.

    Once per 24 hour period for 7 days

  • Change in flow mediated dilation

    Once hourly post exercise for 3 hours

Study Arms (3)

Animal Protein

ACTIVE COMPARATOR
Dietary Supplement: Recovery animal (20g whey) protein supplement

Vegan Protein

ACTIVE COMPARATOR
Dietary Supplement: Recover vegan (26g pea) protein supplement

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo (32g maltodextrin)

Interventions

Recovery animal (20g whey) protein supplementDIETARY_SUPPLEMENT

Animal protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.

Animal Protein
Recover vegan (26g pea) protein supplementDIETARY_SUPPLEMENT

Vegan protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.

Vegan Protein
Placebo (32g maltodextrin)DIETARY_SUPPLEMENT

Placebo consumed post exercise to aid recovery of muscle function following strenuous exercise.

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
  • Use of nutritional supplements
  • Any diagnosed metabolic conditions (diabetes), cardiovascular disease or hypertension
  • Current musculoskeletal injury
  • Use of anti-inflammatory medicines
  • Individuals with non -removable metallic implants (including heart pacemaker, cochlea implants, medication pumps, surgical clips, plates or screws) or claustrophobia
  • Individuals with an allergy to egg, fish, wheat or soy ingredients as the product is manufactured in a facility that contains these ingredients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, EX1 1TX, United Kingdom

Location

MeSH Terms

Interventions

Wheymaltodextrin

Intervention Hierarchy (Ancestors)

MilkBeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and Beverages

Study Officials

  • Francis Stephens

    University of Exeter

    PRINCIPAL INVESTIGATOR

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

September 6, 2019

First Posted

November 7, 2019

Study Start

September 23, 2019

Primary Completion

April 23, 2022

Study Completion

April 23, 2022

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)