SarcopeniaPROMOTeNCT04309292
Protein and Skeletal Muscle in Older Twins: Role of the Gut Microbiome
A study testing Prebiotic food supplement and Protein supplement in people with Sarcopenia and Frailty, run by King's College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Frailty, Age-Related Sarcopenia
- What is being tested?
- Prebiotic food supplement and Protein supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Apr 2021to 20 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dietary Protein and Skeletal Muscle in Older Twins - Targeting the Gut Microbiome to Overcome Anabolic Resistance: The PROMOTe Study
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.
Read more
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.
Read the detailed description
Research Question: Does the gut microbiome contribute to muscle anabolic resistance to protein supplementation in older adults?
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
- Sarcopenia, Frailty, Age-Related Sarcopenia
- Being tested
- Prebiotic food supplement, Protein supplement, Maltrodextrin (placebo)
- Keywords
- gut microbiome, metabolome, prebiotic
- Medical subject headings
- Sarcopenia, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic food supplementDietary supplement
Darmocare Pre = trade name Gut microbiome modulator
Protein supplementDietary supplement
commercially available protein supplementation with high leucine content
Maltrodextrin (placebo)Dietary supplement
Starchy substance
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | protein supplementation plus prebiotic supplementation Receives: Dietary Supplement: Prebiotic food supplement; Dietary Supplement: Protein supplement |
| Placebo Arm | Placebo comparator | Protein supplementation plus placebo Receives: Dietary Supplement: Protein supplement; Dietary Supplement: Maltrodextrin (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and end of study (12 weeks)
Secondary outcomes (10)
Gripstrength, as measured by dynamometer
A marker of muscle strength, measured in kilograms. Dominant hand will be used. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Microbiome composition
faecal samples analysed for their microbial composition, aka the presence of bacteria in the stool. The bacteria present will be identified where possible and quantified. The diversity of the microbiota present will be calculated using standard protocols. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Metabolites in serum
Serum samples analysed for their metabolite composition, aka the presence of metabolites in the blood. Those present will be identified where possible and quantified. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Cognition
CANTAB Battery. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Questionnaire measures: appetite as measured by SNAQ
SNAQ: Simplified Nutritional Appetite Questionnaire (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Questionnaire measures: physical activity as measured by IPAQ
IPAQ: international physical activity questionnaire. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Salivary microbiome
saliva samples analysed for their microbial composition, aka the presence of bacteria in the saliva. The bacteria present will be identified where possible and quantified. The diversity of the microbiota present will be calculated using standard protocols. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Urinary microbiome
Urine samples analysed for their microbial composition, aka the presence of bacteria in the urine. The bacteria present will be identified where possible and quantified. The diversity of the microbiota present will be calculated using standard protocols. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Anthropological measures: height
height, measured in centimetres. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Anthropological measures: weight
measured in kilograms. (absolute and change from baseline at 12 weeks)
Measured: baseline and end of study (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start29 Apr 2021
- Primary completion20 Dec 2021
- Study completion20 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Claire Steves, Principal investigator, The Department of Twin Research & Genetic Epidemiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309292
- Sponsor's protocol ID
- 1234
- Acronym
- PROMOTe
- Status last verified
- Feb 2021
- First submitted
- 5 Feb 2020
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Please see attached document DTR\_DataAccess\_Policy\_0318.pdf for our Data Access Policy.
Publications
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.
PubMed 30036990Ni 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.
PubMed 38424099Ni 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.
PubMed 34210274
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Protein and Skeletal Muscle in Older Twins - Targeting the Gut Microbiome to Overcome Anabolic Resistance: The PROMOTe Study
- ClinicalTrials.gov ID
- NCT04309292
- Acronym / sponsor ID
- PROMOTe / 1234
- Conditions
- Sarcopenia, Frailty, Age-Related Sarcopenia
- Keywords
- gut microbiome, metabolome, prebiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 20 Dec 2021 (actual)
- Study completion
- 20 Dec 2021 (actual)
- First posted
- 16 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Question: Does the gut microbiome contribute to muscle anabolic resistance to protein supplementation in older adults?
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Dietary Supplement: Prebiotic food supplement, Dietary Supplement: Protein supplementprotein supplementation plus prebiotic supplementation |
| Placebo Arm | Placebo comparator | Dietary Supplement: Protein supplement, Dietary Supplement: Maltrodextrin (placebo)Protein supplementation plus placebo |
Who may qualify
- Ages
- 60 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prebiotic food supplementDarmocare Pre = trade name Gut microbiome modulator | Dietary supplement | Treatment Arm |
| Protein supplementcommercially available protein supplementation with high leucine content | Dietary supplement | Placebo Arm, Treatment Arm |
| Maltrodextrin (placebo)Starchy substance | Dietary supplement | Placebo Arm |
Primary outcome
Change in chair rise time
Time frame: baseline and end of study (12 weeks)
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.
10 secondary outcomes
Gripstrength, as measured by dynamometer
Time frame: baseline and end of study (12 weeks)
Microbiome composition
Time frame: baseline and end of study (12 weeks)
Metabolites in serum
Time frame: baseline and end of study (12 weeks)
Cognition
Time frame: baseline and end of study (12 weeks)
Questionnaire measures: appetite as measured by SNAQ
Time frame: baseline and end of study (12 weeks)
Questionnaire measures: physical activity as measured by IPAQ
Time frame: baseline and end of study (12 weeks)
Salivary microbiome
Time frame: baseline and end of study (12 weeks)
Urinary microbiome
Time frame: baseline and end of study (12 weeks)
Anthropological measures: height
Time frame: baseline and end of study (12 weeks)
Anthropological measures: weight
Time frame: baseline and end of study (12 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Background: PubMed 30036990Ni 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.
- Derived from this study: PubMed 38424099Ni 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.
- Derived from this study: PubMed 34210274Ni 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.
- Individual participant dataSharing planned: Yes. Please see attached document DTR_DataAccess_Policy_0318.pdf for our Data Access Policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Steves principal investigator
The Department of Twin Research & Genetic Epidemiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic food supplement and Protein supplement in people with Sarcopenia and Frailty, run by King's College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in chair rise time (time frame: baseline and end of study (12 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04309292, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.