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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03572127
Other study ID # 1718/27
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date May 16, 2018
Est. completion date May 1, 2022

Study information

Verified date May 2021
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 42
Est. completion date May 1, 2022
Est. primary completion date March 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Diet
High protein diet derived from either animal or non-animal sources.

Locations

Country Name City State
United Kingdom University of Exeter, Sports & Health Sciences, College of Life & Environmental Sciences Exeter Devon

Sponsors (2)

Lead Sponsor Collaborator
University of Exeter Quorn

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle Protein Synthesis Muscle protein synthesis measured via deuterium oxide 3 days
Secondary Muscle fiber CSA Changes in muscle fiber CSA 10 weeks
Secondary Muscle Strength Changes in muscle strength 10 weeks
Secondary Muscle CSA Changes in muscle CSA as measured by MRI 10 weeks
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