NCT02980900

Brief Summary

The present study will assess the effect of the type and timing of protein ingestion 6 days prior to, and 7 days following eccentric exercise on the time course of 1) the recovery of muscle function, 2) the recovery of perceived muscle soreness, 3) muscle metabolism.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

November 30, 2016

Last Update Submit

October 11, 2018

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Isokinetic force production of the knee extensor muscles

    14 days

Secondary Outcomes (4)

  • Muscle protein synthesis

    14 days

  • Thigh volume

    14 days

  • Perceived muscle soreness

    14 days

  • Isometric force production of the knee extensor muscles

    14 days

Study Arms (4)

Placebo supplement

PLACEBO COMPARATOR

Post exercise placebo supplement Pre bed placebo supplement

Dietary Supplement: Post exercise placebo supplementDietary Supplement: Pre bed placebo supplement

Post exercise supplement

ACTIVE COMPARATOR

Post exercise protein-polyphenol supplement Pre bed placebo supplement

Dietary Supplement: Post exercise protein-polyphenol supplementDietary Supplement: Pre bed placebo supplement

Pre bed supplement

ACTIVE COMPARATOR

Post exercise placebo supplement Pre bed protein-polyphenol supplement

Dietary Supplement: Post exercise placebo supplementDietary Supplement: Pre bed protein-polyphenol supplement

Post exercise + pre bed supplement

ACTIVE COMPARATOR

Post exercise protein-polyphenol supplement Pre bed protein-polyphenol supplement

Dietary Supplement: Post exercise protein-polyphenol supplementDietary Supplement: Pre bed protein-polyphenol supplement

Interventions

Post exercise protein-polyphenol supplementDIETARY_SUPPLEMENT

Participants will ingest a post exercise protein-polyphenol supplement. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.

Post exercise + pre bed supplementPost exercise supplement
Post exercise placebo supplementDIETARY_SUPPLEMENT

Participants will ingest an isocaloric placebo supplement after exercise. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.

Placebo supplementPre bed supplement
Pre bed protein-polyphenol supplementDIETARY_SUPPLEMENT

Participants will ingest a protein-polyphenol supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.

Post exercise + pre bed supplementPre bed supplement
Pre bed placebo supplementDIETARY_SUPPLEMENT

Participants will ingest an isocaloric placebo supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.

Placebo supplementPost exercise supplement

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Men and women who are generally healthy and recreationally active

You may not qualify if:

  • Active cardiovascular disease or hypertension
  • Diagnosed metabolic impairment
  • Use of nutritional supplements
  • Use of anti-inflammatory medications
  • Habitual dietary protein intake of \<0.8g/kg/day
  • Musculoskeletal disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sport and Health Sciences

Exeter, Devon, EX1 2LU, United Kingdom

Location

Related Publications (1)

  • Jameson TSO, Pavis GF, Dirks ML, Lee BP, Abdelrahman DR, Murton AJ, Porter C, Alamdari N, Mikus CR, Wall BT, Stephens FB. Reducing NF-kappaB Signaling Nutritionally is Associated with Expedited Recovery of Skeletal Muscle Function After Damage. J Clin Endocrinol Metab. 2021 Jun 16;106(7):2057-2076. doi: 10.1210/clinem/dgab106.

    PMID: 33710344DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2016

First Posted

December 2, 2016

Study Start

January 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 16, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)