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

NCT04309292 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2022-10-27

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Prebiotic food supplement

Darmocare Pre = trade name Gut microbiome modulator

DIETARY_SUPPLEMENT

Protein supplement

commercially available protein supplementation with high leucine content

DIETARY_SUPPLEMENT

Maltrodextrin (placebo)

Starchy substance

Sponsors & Collaborators

Principal Investigators

  • Claire Steves · The Department of Twin Research & Genetic Epidemiology

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-04-29
Primary Completion
2021-12-20
Completion
2021-12-20

Countries

  • United Kingdom

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04309292 on ClinicalTrials.gov