Effects of Vitamin C on Skeletal Muscle
VICS
A Crossover Pilot Study on the Effects of Vitamin C Supplementation on Skeletal Muscle in Older Women (VICS)
1 other identifier
interventional
16
1 country
1
Brief Summary
As part of the ageing process muscles become weaker. One of the reasons for this is that mitochondria, the 'engines' that provide energy to fuel muscles, age and work less efficiently. Mitochondria are found in almost all cells in the human body. Mitochondria take in nutrients that are provided from food and break these down to create energy-rich compounds to fuel many different processes in the body. Muscles are loaded with mitochondria because they require a lot of energy. Mitochondria naturally produce small compounds called oxidants that can damage muscle cells and can cause inflammation. The cells in the body have a natural defence system to protect against oxidants, but when mitochondria age and become less efficient, the amount of oxidants that they produce can increase. These oxidants can damage muscles and the mitochondria themselves. Antioxidants, such as vitamin C, may help protect muscles from the damage caused by oxidants, and may help mitochondria work more efficiently. In this study, the investigators will explore whether vitamin C can help mitochondria work more efficiently, which may improve muscle strength, and help older people to remain mobile and independent for longer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy
Started Feb 2024
Typical duration for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
February 5, 2024
CompletedFirst Posted
Study publicly available on registry
February 16, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedFebruary 16, 2024
January 1, 2024
1.1 years
February 5, 2024
February 13, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups.
Comparison of skeletal muscle mitochondrial oxidative capacity (estimated from 31P MRS measured phosphocreatine recovery half-time) following 6 weeks of vitamin C supplementation or 6 weeks of placebo.
Week: 6 and 16
Secondary Outcomes (10)
Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups.
Week: 6 and 16.
Difference in knee extension strength between vitamin C and placebo groups.
Week: 6 and 16.
Difference in hand grip strength between vitamin C and placebo groups.
Week: 6 and 16.
Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups.
Week: 6 and 16.
Difference in plasma vitamin C between vitamin C and placebo groups.
Week: 6 and 16.
- +5 more secondary outcomes
Study Arms (2)
Vitamin C, then Placebo
EXPERIMENTALParticipants will first consume one 500mg vitamin C capsule daily for 6 weeks. After a 4-week washout period, participants will crossover and consume one placebo capsule daily for 6 weeks.
Placebo, then Vitamin C
EXPERIMENTALParticipants will first consume one placebo capsule daily for 6 weeks. After a 4-week washout period, participants will crossover and consume one 500mg vitamin C capsule daily for 6 weeks.
Interventions
Vitamin C 500mg hydroxypropyl methylcellulose (HPMC) capsules (Solgar UK).
Vitamin C-matched placebo capsule. Placebo capsules manufactured using hydroxypropyl methylcellulose (HPMC) capsules and microcrystalline cellulose (MCC).
Eligibility Criteria
You may qualify if:
- Female, aged 65 years or over
- Non-smoker (or ex-smoker for at least 1 year).
- Engages in less than 20 minutes of structured physical activity per week, including cycling.
- Able to provide informed consent.
- Able to understand basic instructions in English.
- Willing to take daily vitamin C or placebo capsules.
You may not qualify if:
- Consumes more than 3 fruits and vegetables per day, including fruit and vegetable juices.
- Consumes vitamin C containing supplements, polyphenols, or other antioxidants (e.g. resveratrol or coenzyme q10).
- Regularly takes anti-inflammatory drugs.
- Alcohol intake \>14 units/week.
- Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, diagnosed low renal function, neurological disorders or diseases that may affect motor/cognitive functions), except hypertension and hyperlipidaemia.
- History of kidney stones within the preceding 12 months.
- Contraindications for undergoing the MRI and exercise study procedures (e.g. major surgery, bilateral hip or knee replacement, non-MRI-compatible pacemaker or metal implants).
- Parallel participation in another research project that involves an intervention.
- Relation to, or co-habitation with, a member of the study team.
- Those who are part of the line manager/supervisory structure of the Chief Investigator.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of East Anglia
Norwich, Norfolk, NR4 7TJ, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Max Yates
Norfolk and Norwich University Hospitals NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Double blind masking
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2024
First Posted
February 16, 2024
Study Start
February 1, 2024
Primary Completion
March 1, 2025
Study Completion
March 1, 2025
Last Updated
February 16, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be made available upon publication of the study results, and will be available for 10 years from the study end date.
- Access Criteria
- Data request must be made by a qualified researcher.
The data supporting the findings of this study will be made available by the authors to any qualified researcher upon reasonable request.