- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05985369
Vegan and Omnivorous Diets and Skeletal Muscle Turnover in Healthy Older Adults (MVP)
The Effects of a High-quality Vegan Diet on Skeletal Muscle Maintenance and Adaptation in Comparison to a Protein-matched Omnivorous Diet in Healthy Older Adults.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ino van der Heijden, MSc
- Phone Number: +441392724774
- Email: iv234@exeter.ac.uk
Study Contact Backup
- Name: Benjamin Wall, Prof
- Phone Number: +441392724774
- Email: B.T.Wall@exeter.ac.uk
Study Locations
-
-
Devond
-
Exeter, Devond, United Kingdom, EX1 2LU
- University of Exeter
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vegan diet
Participants will be allocated to a fully controlled 1-week vegan diet containing 0.8 g/kg BW/day of protein where all protein provided will be derived from non-animal-derived protein sources.
|
Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.
|
Experimental: Omnivorous diet
Participants will be allocated to a fully controlled 1-week omnivorous diet containing 0.8 g/kg BW/day of protein where the majority of protein will be derived from animal-derived protein sources.
|
Participants will adopt a 1-week completely controlled diet and perform 3 sessions of unilateral leg resistance exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle protein synthesis (MPS) in resting and exercised tissue
Time Frame: 7 days
|
Daily MPS rates, expressed as fractional synthetic rate (%/h)
|
7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle morphology
Time Frame: 7 days
|
Changes in muscle thickness during the intervention period, measured via ultrasound
|
7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 524790
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Aging
-
San Diego State UniversityCompleted
-
Lithuanian Sports UniversityCompletedAging | Healthy AgingLithuania
-
Beijing HospitalBGI-ShenzhenCompletedAging | Healthy Aging
-
Northumbria UniversityUniversity of East AngliaSuspendedSleep | Aging | Healthy AgingUnited Kingdom
-
Baskent UniversityCompleted
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
University of StirlingCompletedAging | Healthy Aging | Older Adults | AgedUnited Kingdom
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
-
Amazentis SAAtlantia Food Clinical TrialsCompletedHealthy | Healthy AgingUnited States
Clinical Trials on Controlled diet and resistance exercise
-
Florida State UniversityNutrisystem, Inc.CompletedHypertension | Obesity | Pre-hypertensionUnited States
-
Pusan National University Yangsan HospitalCompletedObesity | OverweightKorea, Republic of
-
Biomedical Research Institute of New MexicoBaylor College of Medicine; National Institute on Aging (NIA)Completed
-
University of Alabama at BirminghamNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed
-
Wageningen UniversityRecruitingSarcopenia | Osteoporosis | Cardiovascular Health | Gut Health | Vegan DietNetherlands
-
Elisa Barron-CabreraRecruitingInflammation | Obesity | Physical Activity | Resistance ExerciseMexico
-
US Department of Veterans AffairsCompletedKidney Failure, ChronicUnited States
-
Cairo UniversityCompletedInsulin Resistance SyndromeEgypt
-
Bahçeşehir UniversityRecruiting
-
University of BathTeagascActive, not recruitingInflammation | Diabetes Mellitus, Type 2 | Insulin Resistance | Gastrointestinal MicrobiomeUnited Kingdom