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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05985369
Other study ID # 524790
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 9, 2022
Est. completion date October 31, 2023

Study information

Verified date April 2024
Source University of Exeter
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Dietary protein intake and physical activity are key to minimise the age-related loss of skeletal muscle mass. While animal-derived protein sources are considered high-quality anabolic foods, it remains unclear whether non-animal-derived (vegan) protein sources support skeletal muscle maintenance and healthy ageing. The aim of the present study is to assess the effect of a vegan diet on daily muscle protein synthesis rates compared to a protein-matched omnivorous diet where the majority of protein is derived from high-quality animal-based protein sources.


Description:

Background: The age-related loss of muscle mass and strength is (partly) explained by a blunted responsiveness of skeletal muscle to the anabolic properties of dietary protein and muscle contraction. Therefore, sufficient dietary protein intake and physical activity are required to minimise age-related muscle atrophy. It remains unknown whether this can be achieved utilising non-animal-derived (vegan) protein sources. Objective: To assess daily muscle protein synthesis rates when adopting a vegan or protein-matched omnivorous control diet. Methods: Healthy older adults (aged 60-80 years) will be randomly allocated to a completely controlled 1-week vegan (providing 0.8 g/kg BW/day protein) or protein-matched omnivorous diet. During this week, participants will perform a set of unilateral leg resistance exercise on day 1, 3, and 5. Deuterium oxide in combination with saliva and muscle sample (from the m. vastus lateralis) collection will be used to measure daily muscle protein synthesis rates in resting and exercised tissue. Value: This will be the first study assessing daily muscle protein turnover in healthy older adults adopting a 1-week vegan diet. This will contribute to the understanding and viability of vegan protein to support active and healthy ageing.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date October 31, 2023
Est. primary completion date October 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 80 Years
Eligibility Inclusion Criteria: - BMI between 18.5 - 30 - Active (not very sedentary and not master athlete; assessed via IPAQ) - Women only: post menopause Exclusion Criteria: - Hypertension (>150/90 mmHg) - Any diagnosed metabolic impairment - Any diagnosed cardiovascular disease - Any diagnosed gastrointestinal disease - Diagnosed cancer - Any medication known to affect muscle metabolism (e.g. hormone replacement therapy) - Severe food allergies or intolerances (e.g. celiac, lactose intolerance, allergic to fungi or algae foods) - Smoking

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Controlled diet and resistance exercise
Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.

Locations

Country Name City State
United Kingdom University of Exeter Exeter Devond

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 (MPS) in resting and exercised tissue Daily MPS rates, expressed as fractional synthetic rate (%/h) 7 days
Secondary Muscle morphology Changes in muscle thickness during the intervention period, measured via ultrasound 7 days
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