NCT04794153

Brief Summary

Background To date, most of the literature investigating the role of dietary protein in muscle growth has focused on isolated protein sources. However, dietary protein is most commonly consumed within a whole food source. Consuming dietary protein within a whole food matrix may additionally stimulate muscle growth. The idea being, there may be other components within food, capable of producing a greater response. Objectives: To assess the effect of consuming a variety of whole food sources, on the stimulation of muscle growth compared to an isolated protein source following a single bout of lower body resistance exercise. Methods Young healthy resistance-trained volunteers will consume a protein rich whole food source, following a bout of lower body resistance exercise. Stable isotope IV infusions and repeated blood and muscle samples will be taken to assess protein digestion and absorption, as well as muscle protein synthesis rates. Value of Research: To determine whether whole food sources potentiate muscle protein synthesis rates (and to what extent across whole food sources) compared to an isolated protein source. In doing so, we can further investigate the nutrients involved that may be contributing to this effect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

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

March 4, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

May 9, 2024

Status Verified

May 1, 2024

Enrollment Period

2.9 years

First QC Date

March 4, 2021

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postprandial Muscle protein Synthetic Response following the ingestion of a protein rich whole food source.

    84 participants will undergo a single bout of lower body exercise followed by the ingestion of one of the six protein rich whole food sources. Using stable isotope tracer methodology and muscle biopsy samples, the postprandial muscle protein synthetic response will be able to be calculated.

    2 years

Study Arms (6)

Pork

EXPERIMENTAL

Locally sourced

Dietary Supplement: whole food sources

Salmon

EXPERIMENTAL

Locally sourced

Dietary Supplement: whole food sources

Mycoprotein

EXPERIMENTAL

Provided by Marlow Foods

Dietary Supplement: whole food sources

Lentils

EXPERIMENTAL

Red

Dietary Supplement: whole food sources

Egg

EXPERIMENTAL

Local supplier

Dietary Supplement: whole food sources

Egg whites

ACTIVE COMPARATOR

Local Supplier

Dietary Supplement: whole food sources

Interventions

whole food sourcesDIETARY_SUPPLEMENT

Foods selected are naturally high in protein and consumed by the general population as part of a meal.

EggEgg whitesLentilsMycoproteinPorkSalmon

Eligibility Criteria

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

You may qualify if:

  • Males and Females
  • BMI 18.5 - 30 kg/m2
  • Aged 18 - 40 years
  • Structured Resistance training consistently for \> 6 months
  • A 5-7 day "washout" period from any supplementation

You may not qualify if:

  • Age \>40 years
  • Body mass index (BMI) \<18.5 or \>30 kg/m2
  • Any metabolic impairments
  • Any cardiovascular impairments
  • High blood pressure (≥140/90 mmHg)
  • Any gastrointestinal disorders
  • Any medications known to affect protein and/or amino acid metabolism
  • A personal or family history of epilepsy, seizures or schizophrenia, motor disorder
  • Chronic over the counter use of pharmaceuticals (\> 1 month)
  • Allergic to any of the whole foods included in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

Study Officials

  • Professor Wall

    University of Exeter

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 11, 2021

Study Start

May 1, 2021

Primary Completion

April 1, 2024

Study Completion

May 1, 2024

Last Updated

May 9, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations