Protein and Skeletal Muscle in Older Twins: Role of the Gut Microbiome
NCT ID: NCT04309292
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
71 participants
INTERVENTIONAL
2021-04-29
2021-12-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Background: Loss of muscle occurs with age and skeletal muscle in older adults can display anabolic resistance to protein in diet. It has been hypothesised that the gut microbiome may play a role in this relationship and therefore could be targeted.
Aim:
This trial aims to test whether modulation of the gut microbiome, in addition to protein supplementation, can improve skeletal muscle function versus protein supplementation alone.
Methods:
Double blinded, randomised, placebo controlled, dietary intervention study. Twin pairs will be randomised to either receive protein supplementation plus placebo or protein supplementation plus a gut microbiome modulator (prebiotic plus probiotic) for 12 weeks. Primary outcome will be muscle function measured using chair-rise time.
Conclusion:
Anabolic resistance warrants further characterisation to guide future therapeutic interventions, especially considering its role in the development of disability, sarcopenia and frailty.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Protein Metabolism in Healthy Older Subjects
NCT02052232
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People
NCT01109628
Mycoprotein as the Basis of a Sustainable Diet to Support Muscle Mass Maintenance and Reconditioning in Older Adults.
NCT04325178
Investigating the Digestibility, Bioavailability and Utilisation of Varied Combined Protein Sources in Older Males Using a Dual Stable Isotope Tracer Technique
NCT07038655
Assessing the Dose-response of Muscle Protein Synthesis to "Super-whey" in Older Adults
NCT05700058
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Background: Loss of skeletal muscle mass and strength occurs with increasing age and is associated with loss of function, disability, and the development of sarcopenia and frailty. Dietary protein is essential for skeletal muscle function, but older adults do not respond as well as younger people to protein, so called 'anabolic resistance'. The aetiology and molecular mechanisms for this are not understood, however a number have been proposed. The gut microbiome is known to play a key role in a number of these postulated mechanisms. This has led us to hypothesise that the gut microbiome may mediate anabolic resistance and could represent an exciting new target for ameliorating muscle loss in older adults.
Aim:
This trial aims to test whether modulation of the gut microbiome, in addition to protein supplementation, can improve skeletal muscle function versus protein supplementation alone.
Methods:
Double blinded, randomised, placebo controlled, dietary intervention study. Volunteers will be recruited in twin pairs from TwinsUK cohort, for which extensive baseline data are available. The twin nature of the study allows for close genetic and environmental matching at baseline. Each pair will be randomised to either receive protein supplementation plus placebo or protein supplementation plus a gut microbiome modulator (prebiotic plus probiotic). Intervention period will be 12 weeks. Clinical and biochemical measures will be taken at 0, and 12 weeks, with 2-monthly contact. Gut microbiota composition will be measured, alongside a battery of physical assessments. Primary outcome will be muscle function measured using chair-rise time. The trial will be delivered remotely using video calls, and postal boxes.
Conclusion:
Anabolic resistance warrants further characterisation to guide future therapeutic interventions, especially considering its role in the development of disability, sarcopenia and frailty. Therapeutic options are badly needed, particularly for older adults who cannot undertake exercise programmes.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment Arm
protein supplementation plus prebiotic supplementation
Prebiotic food supplement
Darmocare Pre = trade name Gut microbiome modulator
Protein supplement
commercially available protein supplementation with high leucine content
Placebo Arm
Protein supplementation plus placebo
Protein supplement
commercially available protein supplementation with high leucine content
Maltrodextrin (placebo)
Starchy substance
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Prebiotic food supplement
Darmocare Pre = trade name Gut microbiome modulator
Protein supplement
commercially available protein supplementation with high leucine content
Maltrodextrin (placebo)
Starchy substance
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Dietary protein intake of \<1.3g/kg/day
* Able to consent
* Able to access video calls on a device such as laptop/tablet
Exclusion Criteria
* Current or recent antibiotic use (preceding 3 months)
* Currently or recent use of protein or leucine supplements (preceding 3 months)
* Currently or recent use of probiotic or prebiotic food supplements (preceding 3 months)
* Current or prior history of gastrointestinal disease e.g. gastrointestinal cancer, inflammatory bowel disease, bariatric surgery, irritable bowel syndrome
* history of any significant injury or surgery which currently affects physical functioning and ability to undertake chair stand test
* weight loss of ≥5% of body weight in preceding 6-12 months
* Currently involved in other intervention studies
* Any condition or circumstance likely to interfere with the normal conduct of the study and interpretation of the results, as judged by the investigators As the study population are over 60 years old, it is assumed that there will be no pregnant women who are eligible to take part.
60 Years
120 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guy's and St Thomas' NHS Foundation Trust
OTHER
King's College London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Claire Steves
Role: PRINCIPAL_INVESTIGATOR
The Department of Twin Research & Genetic Epidemiology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Twin Research and Genetics
London, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Ni Lochlainn M, Bowyer RCE, Steves CJ. Dietary Protein and Muscle in Aging People: The Potential Role of the Gut Microbiome. Nutrients. 2018 Jul 20;10(7):929. doi: 10.3390/nu10070929.
Ni Lochlainn M, Bowyer RCE, Moll JM, Garcia MP, Wadge S, Baleanu AF, Nessa A, Sheedy A, Akdag G, Hart D, Raffaele G, Seed PT, Murphy C, Harridge SDR, Welch AA, Greig C, Whelan K, Steves CJ. Effect of gut microbiome modulation on muscle function and cognition: the PROMOTe randomised controlled trial. Nat Commun. 2024 Feb 29;15(1):1859. doi: 10.1038/s41467-024-46116-y.
Ni Lochlainn M, Nessa A, Sheedy A, Horsfall R, Garcia MP, Hart D, Akdag G, Yarand D, Wadge S, Baleanu AF, Whelan K, Steves C. The PROMOTe study: targeting the gut microbiome with prebiotics to overcome age-related anabolic resistance: protocol for a double-blinded, randomised, placebo-controlled trial. BMC Geriatr. 2021 Jul 1;21(1):407. doi: 10.1186/s12877-021-02301-y.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1234
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.