NCT04325178

Brief Summary

A hallmark of ageing is loss of skeletal muscle mass and strength (sarcopenia). Sarcopenia is explained, partially, by reduced responsiveness of muscle to dietary protein. This 'anabolic resistance' can be overcome by consuming protein in close proximity to exercise and/or adequate amounts across the day. Consequently, there is momentum for a greater protein RDA for older individuals. Concurrently, there is a need to establish an evidence base for the efficacy of non-animal proteins. Mycoprotein is a sustainable non-animal derived protein that imposes a significantly lower environmental burden than animal sources. Our previous work suggests that mycoprotein has the potential to support muscle tissue remodelling to a similar extent as animal derived protein sources. The study will employ a deuterium oxide tracer to quantify muscle protein synthesis over a period of three days in response to a vegan diet or animal based diet, alongside daily unilateral resistance exercise in older adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 13, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2020

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 27, 2020

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

1.5 years

First QC Date

March 4, 2020

Last Update Submit

March 25, 2020

Conditions

AgingSarcopenia

Keywords

AgeingMuscle protein synthesisResistance exerciseSarcopeniaSustainable protein

Outcome Measures

Primary Outcomes (1)

  • Muscle protein synthesis

    Calculation of muscle protein synthesis using the product-precursor method, with deuterium in the body water pool utilised as the precursor and the incorporation of deuterated alanine into muscle tissue as the product.

    Three days.

Secondary Outcomes (1)

  • Resistance-type exercise work done

    Three days.

Study Arms (2)

Animal

EXPERIMENTAL

Participants receive the majority of their protein from animal-derived protein sources (1.8g.kg.day).

Other: Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.

Non-animal

EXPERIMENTAL

Participants receive all their protein from non-animal-derived protein sources (1.8g.kg.day).

Other: Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.

Interventions

Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.OTHER

Participants received a control diet either derived from omnivorous or non-animal food sources, providing 1.8g.kg.day of protein, for a three-day period. Calories were calculated and set to place participants in a state of energy balance. Participants completed three bouts of unilateral resistance exercise, 5 sets of 30 maximal concentric knee extension contractions, on each morning that they received the control diet. During this three-day period participants also consumed a deuterium oxide tracer allowing for the measurement of muscle protein synthesis, in rested and exercised tissue, with incremental biopsies.

AnimalNon-animal

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index between 18 and 30
  • Recreationally active

You may not qualify if:

  • Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes) (as this may affect normal protein metabolism).
  • Any diagnosed cardiovascular disease or hypertension.
  • Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥150mmHg over two or more measurements and an average diastolic blood pressure of ≥90mmHg over two or more measurements.)
  • Chronic use of statins or diabetic medication.
  • A personal or family history of epilepsy, seizures or schizophrenia.
  • Allergic to mycoprotein / Quorn, penicillin, or milk.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Exeter

Exeter, Devon, EX1 2LU, United Kingdom

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

Proteins

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Design

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

Study Record Dates

First Submitted

March 4, 2020

First Posted

March 27, 2020

Study Start

March 22, 2018

Primary Completion

September 13, 2019

Study Completion

January 31, 2020

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)