HealthyVICSNCT06262711
Effects of Vitamin C on Skeletal Muscle
A study testing Vitamin C in people with Healthy, run by University of East Anglia at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2024to Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Professor Ailsa Welch contact
United Kingdom1 site
University of East Anglia
Norwich, Norfolk, NR4 7TJ
About this study
Official title: A Crossover Pilot Study on the Effects of Vitamin C Supplementation on Skeletal Muscle in Older Women (VICS)
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.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin CDietary supplement
Vitamin C 500mg hydroxypropyl methylcellulose (HPMC) capsules (Solgar UK).
PlaceboDietary supplement
Vitamin C-matched placebo capsule. Placebo capsules manufactured using hydroxypropyl methylcellulose (HPMC) capsules and microcrystalline cellulose (MCC).
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C, then Placebo | Experimental | Participants 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. Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Placebo |
| Placebo, then Vitamin C | Experimental | Participants 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. Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week: 6 and 16
Secondary outcomes (10)
Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups.
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.
Measured: Week: 6 and 16.
Difference in knee extension strength between vitamin C and placebo groups.
Comparison of knee extension strength following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Difference in hand grip strength between vitamin C and placebo groups.
Comparison of hand grip strength following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups.
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.
Measured: Week: 6 and 16.
Difference in plasma vitamin C between vitamin C and placebo groups.
Comparison of plasma vitamin C following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Difference in serum hs-CRP between vitamin C and placebo groups.
Comparison of serum hs-CRP following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Difference in serum IL-6 between vitamin C and placebo groups.
Comparison of serum IL-6 following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Difference in serum TNF-α between vitamin C and placebo groups.
Comparison of serum TNF-α following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Difference in plasma P1NP between vitamin C and placebo groups.
Comparison of plasma P1NP following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Difference in plasma CTX between vitamin C and placebo groups.
Comparison of plasma CTX following 6 weeks of vitamin C or 6 weeks of placebo.
Measured: Week: 6 and 16.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study startFeb 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, The Quadram Institute Clinical Research Facility
- Responsible party
- Sponsor
- Investigators
- Dr Max Yates, Principal investigator, Norfolk and Norwich University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262711
- Sponsor's protocol ID
- 321917
- Acronym
- VICS
- Status last verified
- Jan 2024
- First submitted
- 5 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data supporting the findings of this study will be made available by the authors to any qualified researcher upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Pilot Study on the Effects of Vitamin C Supplementation on Skeletal Muscle in Older Women (VICS)
- ClinicalTrials.gov ID
- NCT06262711
- Acronym / sponsor ID
- VICS / 321917
- Conditions
- Healthy
- Keywords
- skeletal muscle, mitochondrial function, muscle strength, physical function, vitamin C
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Norfolk and Norwich University Hospitals NHS Foundation Trust, The Quadram Institute Clinical Research Facility
- Study start
- Feb 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Vitamin C, then Placebo | Experimental | Dietary Supplement: Vitamin C, Dietary Supplement: PlaceboParticipants 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 | Experimental | Dietary Supplement: Vitamin C, Dietary Supplement: PlaceboParticipants 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vitamin CVitamin C 500mg hydroxypropyl methylcellulose (HPMC) capsules (Solgar UK). | Dietary supplement | Placebo, then Vitamin C, Vitamin C, then Placebo |
| PlaceboVitamin C-matched placebo capsule. Placebo capsules manufactured using hydroxypropyl methylcellulose (HPMC) capsules and microcrystalline cellulose (MCC). | Dietary supplement | Placebo, then Vitamin C, Vitamin C, then Placebo |
Primary outcome
Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups.
Time frame: Week: 6 and 16
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.
10 secondary outcomes
Difference in skeletal muscle phosphomonoester to phosphodiester ratio (PME/PDE) between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in knee extension strength between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in hand grip strength between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in Short Physical Performance Battery (SPPB) score between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in plasma vitamin C between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in serum hs-CRP between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in serum IL-6 between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in serum TNF-α between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in plasma P1NP between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Difference in plasma CTX between vitamin C and placebo groups.
Time frame: Week: 6 and 16.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
- Individual participant dataSharing planned: Yes. The data supporting the findings of this study will be made available by the authors to any qualified researcher upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Professor Ailsa Welch contact
Dr Max Yates principal investigator
Norfolk and Norwich University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin C in people with Healthy, run by University of East Anglia at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jamie Scott (01603591074, J.Scott2@uea.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in skeletal muscle mitochondrial function between vitamin C and placebo groups. (time frame: Week: 6 and 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.