Dietary supplements, exercise, and muscle ageing
| ISRCTN | ISRCTN23294745 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23294745 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 312170 |
| Protocol serial number | IRAS 312170 |
| Sponsor | University of Bradford |
| Funder | University of Bradford |
- Submission date
- 08/10/2022
- Registration date
- 27/03/2023
- Last edited
- 27/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims.
Loss of skeletal muscle mass and function is strongly associated with frailty, trips and falls, and a reduction in quality of life in elderly people. There are currently limited effective treatments for reducing loss of muscle and muscle function with ageing, and as we have an ageing population, addressing this issue is an important challenge. Current treatment options are limited to undertaking exercise and increasing protein intake, although these interventions are not effective for everyone. Nitrate supplementation has been suggested to have benefits for muscle function, but this has not been fully tested throughout the human life course. This study aims to determine the effect of nitrate and protein supplementation in young, middle-aged and aged participants, and the effect of exercise, nitrate and exercise, or protein and exercise in aged participants, on skeletal muscle function. The study will also assess some markers of cellular damage to gain insight into how any effects seen may be working.
Who can participate?
Adults aged 18 years or older who are healthy
What does the study involve?
Participants will undertake a selection of baseline measurements (e.g., height, weight, blood pressure, body composition), answer some questionnaires (about diet and quality of life) and undertake a battery of physical function tests. Blood samples and (if participants are happy to do so) a muscle biopsy will be taken. They will then be assigned to an intervention group (nitrate only, protein only, exercise only, nitrate and exercise, or protein and exercise). Participants will take the assigned intervention for 12 months, with follow-up visits at 3, 6, 9, and 12 months, where they will do the physical function tests, blood sampling, and (if happy to do so) muscle biopsy sampling, at each follow-up visit.
What are the possible benefits and risks of participating?
The study aims to understand muscle ageing across the human life course, and the effect of nitrate, protein and exercise on muscle function. This study will provide insight into the use of nitrate and/or protein supplementation, and exercise, as a way of reducing the debilitating effects of muscle ageing on quality of life, particularly in the elderly. Increased protein and exercise have previously been suggested to improve muscle mass and function (at least in some people), so participants doing these interventions in this study may benefit from these effects.
The study is making use of commercially-sourced nitrate and protein supplements, which are generally well-tolerated by the general population. However, there is a small risk these supplements may not agree with you. The researchers will also be asking participants if they would be happy for a muscle biopsy to be taken at each visit. This can feel a bit uncomfortable afterwards, and there is a small risk of infection associated with these biopsies.
Where is the study run from?
University of Bradford (UK)
When is the study starting and how long is it expected to run for?
August 2022 to October 2024
Who is funding the study?
University of Bradford (UK)
Who is the main contact?
Dr Huw Jones, H.S.Jones@bradford.ac.uk
Contact information
Principal investigator
Institute of Cancer Therapeutics
University of Bradford
Richmond Road
Bradford
BD7 1DP
United Kingdom
 ORCID ID |
0000-0001-9846-5268 |
|---|---|
| Phone | +44 (0)1274 234217 |
| h.s.jones@bradford.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-centre randomized parallel trial |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Developing interventions and investigating molecular markers of age-related sarcopenia |
| Study acronym | DIMMAS |
| Study objectives | Dietary interventions (e.g. protein and nitrate) and exercise can modulate muscle ageing throughout the lifecourse. |
| Ethics approval(s) | Approved 16/01/2023, London - Brighton & Sussex Research Ethics Committee (Health Research Authority, 2 Redman Place, Stratford, London, E20 1JQ, UK; +44 (0)2071048202; brightonandsussex.rec@hra.nhs.uk), ref: 22/PR/1028 |
| Health condition(s) or problem(s) studied | Skeletal muscle ageing throughout the life course (aged 18+ years) |
| Intervention | Participants will undertake the intervention for up to 12 months. For single interventions (e.g. nitrate only, protein only, exercise only) participants will not be randomised. For comparisons with combined interventions, randomisation will occur. All participants will act as their own baseline control. Randomisation of sub-group allocation for the older participants will be implemented by assigning the exercise intervention to every other participant aged 69+ years recruited to the study. This approach ensures no bias from the study team and that the intervention is assigned pre-sarcopenia assessment and baseline testing. 1. Nitrate only (commercial beetroot extract - oral) 2. Protein only (commercial protein supplement - oral) 3. Exercise only (graded based on isokinetic dynamometer results). Participants undertake a graded mixed modal protocol that gets progressively more intense over 3 months and is reviewed every 3 months. Exercise for 1 hour, 3 times a week) 4. Exercise and protein (as above) 5. Exercise and nitrate (as above) |
| Intervention type | Mixed |
| Primary outcome measure(s) |
Physical function measured using isokinetic dynamometer of knee extension and flexion at baseline and follow-up visits (baseline, 3, 6, 9, and 12 months) |
| Key secondary outcome measure(s) |
1. Hand grip strength quantified using an isometric dynamometer at baseline, 3, 6, 9 and 12 months |
| Completion date | 01/10/2024 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 420 |
| Key inclusion criteria | 1. Healthy volunteers 2. Asymptomatic 3. 18+ years of age |
| Key exclusion criteria | 1. Previous history of muscle disorder 2. Cardiac issues 3. Medication which is known to affect muscles, including statins and steroids 4. Contraindications to exercise 5. Pregnant or breastfeeding 6. Known allergies 7. Volunteers on blood thinning medication 8. Known renal impairment 9. Adults lacking capacity (not compos mentis) |
| Date of first enrolment | 30/01/2023 |
| Date of final enrolment | 01/10/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Bradford
BD7 1DP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Blinded raw data will be made available on request if necessary (e.g. part of publication process). Participant identifiers will not be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
25/01/2023: Trial's existence confirmed by the London - Brighton & Sussex Research Ethics Committee.
