Mycoprotein, Resistance Training, and Hypertrophy (HAM)

May 20, 2021 updated by: University of Exeter

Does Obtaining the Majority of Dietary Protein From Non-animal Sources Support the Skeletal Muscle Adaptive Response to Structured Resistance Training in Young Men and Women

Protein is vital for the preservation of health and optimal adaptation to training. However, animal proteins come with economic and environmental issues. The study will investigate the effect of non-animal vs animal based habitual protein consumption on muscle protein metabolism and changes in muscle mass and function over a longer period of time.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Protein is vital for the preservation of health and optimal adaptation to training. However, animal proteins come with a number of economic and environmental issues. Accordingly, the investigators need to develop an evidence base for more sustainable dietary proteins to support human nutrition. Mycoprotein is a non-animal protein produced by the continuous fermentation of the fungus Fusarium Venenatum. Previously, in a mechanistic study, it was determined that a single bolus of mycoprotein effectively supports muscle building in both rested and exercised skeletal muscle, to a similar extent as what would be expected of animal proteins. This suggests that similar adaptation of muscle tissue during training could be achieved when protein is obtained from non-animal derived protein sources.

The study will investigate the effect of high non-animal vs animal based habitual protein consumption on muscle protein metabolism and changes in muscle mass and function over a longer period of time. Initially, the study will employ a stable isotope tracer to quantify muscle protein synthesis over a period of three days in healthy male and female volunteers. During this time participants will consume a controlled vegan diet or an animal based diet, with daily unilateral resistance exercise. The second phase of the study will employ a 10 week diet and resistance training intervention, with the majority of a participant's protein either coming from animal or non-animal sources. This will determine the ability of a largely non-animal derived diet to support augmentations in muscle size and strength.

Briefly, participants will undergo 6 muscle biopsies over the course of an 11 week period. Initial biopsies will quantify muscle protein synthesis. Subsequent biopsies will characterise the adaptive response to the effects of nutrition and exercise. MRI scans will be employed to determine changes in muscle volume, and DXA scans will measure changes in body composition.

Study Type

Interventional

Enrollment (Anticipated)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Devon
      • Exeter, Devon, United Kingdom, EX1 2LU
        • University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males and females 18 - 40 years of age.
  • Body mass index between 18 and 30.
  • Recreationally active.
  • Resistance training experienced (have previous performed resistance exercise, and are familiar with the basic movements).

Exclusion Criteria:

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) (as this may affect normal protein metabolism).
  • Any diagnosed cardiovascular disease or hypertension (to avoid any complications associated with heavy exercise).
  • Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
  • Chronic use of any prescribed or over the counter pharmaceuticals (that may modulate muscle protein metabolism).
  • A personal or family history of epilepsy, seizures or schizophrenia.
  • Allergic to mycoprotein / Quorn, penicillin, or milk.
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-animal derived diet
High protein diet derived from non-animal sources.
High protein diet derived from either animal or non-animal sources.
Active Comparator: Animal derived diet
High protein diet derived from animal sources.
High protein diet derived from either animal or non-animal sources.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle Protein Synthesis
Time Frame: 3 days
Muscle protein synthesis measured via deuterium oxide
3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Muscle fiber CSA
Time Frame: 10 weeks
Changes in muscle fiber CSA
10 weeks
Muscle Strength
Time Frame: 10 weeks
Changes in muscle strength
10 weeks
Muscle CSA
Time Frame: 10 weeks
Changes in muscle CSA as measured by MRI
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2018

Primary Completion (Actual)

March 1, 2020

Study Completion (Anticipated)

May 1, 2022

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

May 21, 2021

Last Update Submitted That Met QC Criteria

May 20, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1718/27

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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