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Effects of Vitamin C on Skeletal Muscle

A Crossover Pilot Study on the Effects of Vitamin C Supplementation on Skeletal Muscle in Older Women (VICS)

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06262711
Acronym
VICS
Enrollment
16
Registered
2024-02-16
Start date
2024-02-29
Completion date
2025-03-31
Last updated
2024-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

skeletal muscle, mitochondrial function, muscle strength, physical function, vitamin C

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.

Detailed description

The VICS study is a 16-week randomised, double-blind, placebo-controlled two-arm crossover pilot study conducted between the Norfolk and Norwich University Hospital (NNUH) and the Quadram Institute Clinical Research Facility (QI CRF) in Norwich, UK. Investigators are seeking women over the age of 65 years with low habitual fruit and vegetable consumption to determine whether vitamin C supplementation affects mitochondrial function, compared to a matched placebo. Participants will attend 3 clinical visits where investigators will assess skeletal muscle mitochondrial function and membrane turnover using 31-phosphorous magnetic resonance spectroscopy (31P MRS). Investigators will assess muscle strength (hand grip strength and knee extension strength) measured using handheld dynamometers, and physical function measured using the short physical performance battery (SPPB). Investigators will monitor blood levels of vitamin C and inflammatory markers, specifically high-sensitivity C-reactive protein (hs-CRP), interleukin-6 (IL-6) and tumour necrosis factor-α (TNF-α), and the collagen markers procollagen type-1 N-terminal propeptide (P1NP) and collagen type-1 cross-linked C telopeptide (CTX). Participants will consume one oral capsule daily (containing either 500mg vitamin C or a matched placebo) for the first 6-week intervention period, then, after a 4-week washout phase, participants will crossover and consume the other capsule daily for the second 6-week intervention period. Participants will be asked to complete a food frequency (dietary) questionnaire and physical activity questionnaire at each visit to monitor their physical activity levels and fruit and vegetable consumption.

Interventions

DIETARY_SUPPLEMENTVitamin C

Vitamin C 500mg hydroxypropyl methylcellulose (HPMC) capsules (Solgar UK).

DIETARY_SUPPLEMENTPlacebo

Vitamin C-matched placebo capsule. Placebo capsules manufactured using hydroxypropyl methylcellulose (HPMC) capsules and microcrystalline cellulose (MCC).

Sponsors

The Norfolk and Norwich University Hospitals NHS Foundation Trust
CollaboratorUNKNOWN
The Quadram Institute Clinical Research Facility
CollaboratorUNKNOWN
University of East Anglia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

Double blind masking

Intervention model description

Crossover Assignment

Eligibility

Sex/Gender
FEMALE
Age
65 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups.Week: 6 and 16Comparison 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.

Secondary

MeasureTime frameDescription
Difference in knee extension strength between vitamin C and placebo groups.Week: 6 and 16.Comparison of knee extension strength following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in hand grip strength between vitamin C and placebo groups.Week: 6 and 16.Comparison of hand grip strength following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups.Week: 6 and 16.The Short Physical Performance Battery (SPPB) assesses three components of physical performance: standing balance, gait speed and chair stands. Each of the three components is scored from 0 (worst possible performance) to 4 (best possible performance). Scores from each of the three components are then summed to provide an overall SPPB score ranging from 0 (worst performance) to 12 (best performance). Comparison of SPPB score following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in plasma vitamin C between vitamin C and placebo groups.Week: 6 and 16.Comparison of plasma vitamin C following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups.Week: 6 and 16.Skeletal muscle phosphomonoester (PME) and phosphodiester (PDE) concentrations can be measured using 31P MRS, and reflect cell membrane synthesis and breakdown respectively. The signal amplitudes (in arbitrary units) of these two species will be combined to report the (unitless) PME/PDE ratio, which reflects cell membrane turnover and may be related to oxidative stress. Comparison of PME/PDE ratio following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in serum IL-6 between vitamin C and placebo groups.Week: 6 and 16.Comparison of serum IL-6 following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in serum TNF-α between vitamin C and placebo groups.Week: 6 and 16.Comparison of serum TNF-α following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in plasma P1NP between vitamin C and placebo groups.Week: 6 and 16.Comparison of plasma P1NP following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in plasma CTX between vitamin C and placebo groups.Week: 6 and 16.Comparison of plasma CTX following 6 weeks of vitamin C or 6 weeks of placebo.
Difference in serum hs-CRP between vitamin C and placebo groups.Week: 6 and 16.Comparison of serum hs-CRP following 6 weeks of vitamin C or 6 weeks of placebo.

Countries

United Kingdom

Contacts

Primary ContactJamie Scott
J.Scott2@uea.ac.uk01603591074
Backup ContactProfessor Ailsa Welch
A.Welch@uea.ac.uk

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026