Protein and Skeletal Muscle in Older Twins: Role of the Gut Microbiome

NCT04309292 | Completed

• 1 other identifier: 1234
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

Research Question: Does the gut microbiome contribute to muscle anabolic resistance to protein supplementation in older adults? 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.

Conditions

Sarcopenia; Frailty; Age-Related Sarcopenia

Keywords

gut microbiome; metabolome; prebiotic

Outcome Measures

Primary Outcomes (1)

• Change in chair rise time

  Chair rise time refers to the time it takes to complete 5 chair rises, without using arms. It is a well-recognised proxy marker of muscle strength. The change from baseline chair rise time at 12 weeks is the primary outcome. The residuals of change will be used in analysis.

  baseline and end of study (12 weeks)

Secondary Outcomes (10)

• Gripstrength, as measured by dynamometer

  baseline and end of study (12 weeks)

• Microbiome composition

  baseline and end of study (12 weeks)

• Metabolites in serum

  baseline and end of study (12 weeks)

• Cognition

  baseline and end of study (12 weeks)

• Questionnaire measures: appetite as measured by SNAQ

  baseline and end of study (12 weeks)

Study Arms (2)

Treatment Arm

EXPERIMENTAL

protein supplementation plus prebiotic supplementation

Dietary Supplement: Prebiotic food supplement; Dietary Supplement: Protein supplement

Placebo Arm

PLACEBO COMPARATOR

Protein supplementation plus placebo

Dietary Supplement: Protein supplement; Dietary Supplement: Maltrodextrin (placebo)

Interventions

Prebiotic food supplement DIETARY_SUPPLEMENT

Darmocare Pre = trade name Gut microbiome modulator

Treatment Arm

Protein supplement DIETARY_SUPPLEMENT

commercially available protein supplementation with high leucine content

Placebo Arm; Treatment Arm

Maltrodextrin (placebo) DIETARY_SUPPLEMENT

Starchy substance

Placebo Arm

Eligibility Criteria

• Age: 60 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged \>=60 years
• Dietary protein intake of \<1.3g/kg/day
• Able to consent
• Able to access video calls on a device such as laptop/tablet

You may not qualify if:

• Severe food allergy
• 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.

Sponsors & Collaborators

• King's College London: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator

Study Sites (1)

Department of Twin Research and Genetics

London, United Kingdom

Location

Related Publications (3)

• 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.

  PMID: 30036990 BACKGROUND

• 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.

  PMID: 38424099 DERIVED

• 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.

  PMID: 34210274 DERIVED

MeSH Terms

Conditions

Sarcopenia; Frailty

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes

Study Officials

• Claire Steves

  The Department of Twin Research & Genetic Epidemiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: March 16, 2020
• Study Start: April 29, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: October 27, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available after the study has been completed and all results analysed. We estimate this to be approximately 2023. The data will remain available for the foreseeable future with no end date in sight at present.
• Access Criteria: Please see attached document DTR\ DataAccess\ Policy\ 0318.pdf for our Data Access Policy.

Locations

GB (1)