Mycoprotein, Resistance Training, and Hypertrophy (HAM)
Primary Purpose
Hypertrophy
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Diet
Sponsored by
About this trial
This is an interventional basic science trial for Hypertrophy focused on measuring Protein, Resistance Exercise, Skeletal Muscle, Mycoprotein, Sustainability
Eligibility Criteria
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.
Sites / Locations
- University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Non-animal derived diet
Animal derived diet
Arm Description
High protein diet derived from non-animal sources.
High protein diet derived from animal sources.
Outcomes
Primary Outcome Measures
Muscle Protein Synthesis
Muscle protein synthesis measured via deuterium oxide
Secondary Outcome Measures
Muscle fiber CSA
Changes in muscle fiber CSA
Muscle Strength
Changes in muscle strength
Muscle CSA
Changes in muscle CSA as measured by MRI
Full Information
NCT ID
NCT03572127
First Posted
May 21, 2018
Last Updated
May 20, 2021
Sponsor
University of Exeter
Collaborators
Quorn
1. Study Identification
Unique Protocol Identification Number
NCT03572127
Brief Title
Mycoprotein, Resistance Training, and Hypertrophy
Acronym
HAM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 16, 2018 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
May 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Exeter
Collaborators
Quorn
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertrophy
Keywords
Protein, Resistance Exercise, Skeletal Muscle, Mycoprotein, Sustainability
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will consume a non-animal derived high protein diet, whilst the other group will consume a more traditional animal protein based diet.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-animal derived diet
Arm Type
Experimental
Arm Description
High protein diet derived from non-animal sources.
Arm Title
Animal derived diet
Arm Type
Active Comparator
Arm Description
High protein diet derived from animal sources.
Intervention Type
Other
Intervention Name(s)
Diet
Intervention Description
High protein diet derived from either animal or non-animal sources.
Primary Outcome Measure Information:
Title
Muscle Protein Synthesis
Description
Muscle protein synthesis measured via deuterium oxide
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Muscle fiber CSA
Description
Changes in muscle fiber CSA
Time Frame
10 weeks
Title
Muscle Strength
Description
Changes in muscle strength
Time Frame
10 weeks
Title
Muscle CSA
Description
Changes in muscle CSA as measured by MRI
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX1 2LU
Country
United Kingdom
12. IPD Sharing Statement
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Mycoprotein, Resistance Training, and Hypertrophy
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