Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04325178
Other study ID # uexeter
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 22, 2018
Est. completion date January 31, 2020

Study information

Verified date March 2020
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Dietary protein plays a critical role in the daily regulation of muscle mass by virtue of its ability to regularly stimulate muscle protein synthesis rates. Sarcopenia is mechanistically explained, at least in part, by the reduced responsiveness of older adult's muscle tissue to these anabolic properties of dietary protein. However, this 'anabolic resistance' can be overcome by paying attention to the synergy that exists between the anabolic effects of dietary protein and physical activity. Specifically, consuming dietary protein in close temporal proximity to physical activity and/or adequate amounts of dietary protein per meal is an effective strategy to optimise muscle protein metabolism in older adults. These mechanistic, physiological findings are supported by longitudinal studies showing that older individuals who consume modestly greater amounts of dietary protein than the current RDA, and/or maintain/adopt an active lifestyle, experience reduced rates of sarcopenia and typically live healthier lives.

With the importance of dietary protein to support active, healthy ageing evident, and a consequent scientific momentum moving towards a considerable (≥50%) rise in recommended protein intake for older individuals, the inevitable question arises: 'where should this dietary protein to support healthy ageing come from?' Current and future generations are required to view developments in human nutrition through the lens of mounting challenges associated with the sustainability of increased production of animal proteins, a concern also of primary importance to Quorn Foods. However, research into the nutritional physiology of alternative, sustainable, non-animal derived protein sources is in its infancy, particularly so in older adults. Therefore, there is considerable scientific interest, public health value and commercial opportunity in establishing a robust evidence base for the efficacy of non-animal, sustainably produced dietary protein sources to support active, healthy ageing.

Mycoprotein, a food source produced by continuous fermentation of the filamentous fungus Fusarium venenatum, imposes a significantly lower environmental burden during its production compared with animal sources. In collaboration with Quorn Foods, we recently reported that acute consumption of mycoprotein in young adults results in equivalent amino acid bioavailability to that of milk protein, and therefore shows promise as a protein source to support muscle anabolism and metabolic health in numerous populations. In the present proposal, we wish to translate and extend these findings into the older adult population. We will exploit a stable isotope tracer approach (oral administration of deuterium oxide ['heavy water']) to make in vivo measurements of cumulative, free living muscle protein synthesis rates in response to a highly sustainable, non-animal derived, mycoprotein based diet with or without physical activity, compared with a more traditional diet reliant on animal derived protein sources (matched for total protein). The study will increase our knowledge of how effective non-animal derived proteins are at supporting muscle tissue remodelling in the elderly.


Recruitment information / eligibility

Status Completed
Enrollment 19
Est. completion date January 31, 2020
Est. primary completion date September 13, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 55 Years to 75 Years
Eligibility Inclusion Criteria:

- Body mass index between 18 and 30

- Recreationally active

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.

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United Kingdom University of Exeter Exeter Devon

Sponsors (1)

Lead Sponsor Collaborator
University of Exeter

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Resistance-type exercise work done The work done (J) over 5 sets of 30 isokinetic knee extension contractions, on three consecutive days. Three days.
See also
  Status Clinical Trial Phase
Completed NCT05433233 - Effects of Lifestyle Walking on Blood Pressure in Older Adults With Hypertension N/A
Recruiting NCT06032065 - Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD) Phase 3
Completed NCT05293730 - Trial of the Impact of the Electronic Frailty Integrated With Social Needs N/A
Recruiting NCT03932162 - Gene Expression Changes In Young and Geriatric Skin Early Phase 1
Completed NCT04064528 - Effects of Age on Amino Acid Delivery to Tendon N/A
Completed NCT03366129 - Blood-Brain Barrier Disruption in People With White Matter Hyperintensities Who Have Had a Stroke
Completed NCT06029920 - Influence of Overground Walking on Biomarkers, Cognitive Function, and Quality of Life in Elderly With Mild Cognitive Impairment N/A
Recruiting NCT05566938 - Study to Design a Precision Nutrition Strategy at a Group Level in the Elderly N/A
Recruiting NCT05543980 - Leg Heat Therapy in Elderly Individuals Phase 2
Completed NCT04894929 - Comprehensive Geriatric Assessment in the Monitoring of Functional Improvement N/A
Not yet recruiting NCT06071130 - Emotion, Aging, and Decision Making N/A
Enrolling by invitation NCT04641663 - Multi-target Dietary Supplement Tolerability in an Aging Population (MTDSST) N/A
Completed NCT04088006 - The Evaluation of Efficacy and Safety of Hyaluronic Acid Injection on Skin Moisturization and Elasticity N/A
Completed NCT03695081 - Patient Pathway Pharmacist - Optimal Drug-related Care N/A
Recruiting NCT05424263 - Acetate and Age-associated Arterial Dysfunction Phase 2
Completed NCT05601713 - Mitigating Heat-induced Physiological Strain and Discomfort in Older Adults Via Lower Limb Immersion and Neck Cooling N/A
Completed NCT04551339 - Zinc Versus Multivitamin Micronutrient Supplementation in the Setting of COVID-19 N/A
Recruiting NCT04997577 - Speech Perception and High Cognitive Demand N/A
Completed NCT05922475 - Efficacy of Pre-sleep or Post-exercise Protein During 12 Weeks of Resistance Exercise Training N/A
Completed NCT04015479 - Peanut Protein Supplementation to Augment Muscle Growth and Improve Markers of Muscle Quality and Health in Older Adults N/A