NCT06262711

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2024

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 5, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

February 16, 2024

Status Verified

January 1, 2024

Enrollment Period

1.1 years

First QC Date

February 5, 2024

Last Update Submit

February 13, 2024

Conditions

Keywords

skeletal musclemitochondrial functionmuscle strengthphysical functionvitamin C

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

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.

Dietary Supplement: Vitamin CDietary 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.

Dietary Supplement: Vitamin CDietary Supplement: Placebo

Interventions

Vitamin CDIETARY_SUPPLEMENT

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

Placebo, then Vitamin CVitamin C, then Placebo
PlaceboDIETARY_SUPPLEMENT

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

Placebo, then Vitamin CVitamin C, then Placebo

Eligibility Criteria

Age65 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsBiological Females
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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

Location

MeSH Terms

Interventions

Ascorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • Dr Max Yates

    Norfolk and Norwich University Hospitals NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Professor Ailsa Welch

CONTACT

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
Model Details: Crossover Assignment
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

The data supporting the findings of this study will be made available by the authors to any qualified researcher upon reasonable request.

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.

Locations