Frailty SyndromeNCT03995342
The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly
A study testing Inulin and Maltodextrin in people with Frailty Syndrome, run by Xijing Hospital at 1 site in China.
Trial summary
The study aim to evaluate the improvement and correlation of soluble dietary fiber (prebiotics) in the frailty of elderly people by a randomized, double-blind, placebo-controlled clinical trial. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Frailty Syndrome
- What is being tested?
- Inulin and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2019to 31 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥65 years;
- Can get up from a chair and walk 6 meters
- Clearly consciousness, able to read or use words to express and communicate without difficulty
- Agree and accept the study plan
Who cannot join
- Acute and chronic inflammatory disease of the intestine within 3 months
- Use of antibiotics, probiotics, prebiotics or synthetics, laxatives or diarrhea medications, proton pump inhibitors or gastric motility drugs within 1 month
- Dementia
- mental illness or blindness
- acute infection
- cancer
Trial locations and contacts
1 site in 1 country.
About this study
The study aim to evaluate the improvement and correlation of soluble dietary fiber (prebiotics) in the frailty of elderly people by a randomized, double-blind, placebo-controlled clinical trial.
Read the detailed description
100 healthy controls, 100 pre-frailty and 100 frailty elderly will be included. the healthy controls will be received no intervention. The pre-frailty will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin) . The degree of improvements and correlation in frailty will be evaluated three months later.Similarly,the frailty also will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin). The degree of improvements and correlation in frailty will be evaluated three months later.
- Conditions
- Frailty Syndrome
- Being tested
- Inulin, Maltodextrin
- Keywords
- frailty, flora
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InulinDietary supplement
Inulin 15 grams after dissolution by mouth， every morning for three months.
MaltodextrinDietary supplement
Also called Placebo
Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution
| Study group | Role | What they receive |
|---|---|---|
| exprimental: Inulin | Experimental | Inulin 15 grams after dissolution by mouth， every morning for three months. Receives: Dietary Supplement: Inulin |
| Active comparator: maltodextrin | Placebo comparator | Placebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months. Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of frailty
Frailty will be diagnosed according to Fried criteria
Measured: 3 months
Secondary outcomes (1)
Diversity analysis of intestinal flora
Change of diversity analysis of intestinal flora
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty SyndromeStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Xiaoming-1, Xijing Hospital
- Investigators
- Wang xiao ming, Study chair, Director of geriatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995342
- Sponsor's protocol ID
- KY20192015-F-1
- Status last verified
- Jul 2024
- First submitted
- 10 Jun 2019
- Last updated
- 17 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not make individual participant data (IPD) available to other researchers in a few years.
Publications
Yang J, Hou L, Wang A, Shang L, Jia X, Xu R, Wang X. Prebiotics improve frailty status in community-dwelling older individuals in a double-blind, randomized, controlled trial. J Clin Invest. 2024 Aug 6;134(18):e176507. doi: 10.1172/JCI176507.
PubMed 39286985
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly
- ClinicalTrials.gov ID
- NCT03995342
- Acronym / sponsor ID
- KY20192015-F-1
- Conditions
- Frailty Syndrome
- Keywords
- frailty, flora
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 Jun 2019 (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.
The study aim to evaluate the improvement and correlation of soluble dietary fiber (prebiotics) in the frailty of elderly people by a randomized, double-blind, placebo-controlled clinical trial.
Detailed description
100 healthy controls, 100 pre-frailty and 100 frailty elderly will be included. the healthy controls will be received no intervention. The pre-frailty will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin) . The degree of improvements and correlation in frailty will be evaluated three months later.Similarly,the frailty also will be randomized at a 1：1 ratio to receive prebiotics (inulin) or placebo (maltodextrin). The degree of improvements and correlation in frailty will be evaluated three months later.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exprimental: Inulin | Experimental | Dietary Supplement: InulinInulin 15 grams after dissolution by mouth， every morning for three months. |
| Active comparator: maltodextrin | Placebo comparator | Dietary Supplement: MaltodextrinPlacebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age ≥65 years;
- Can get up from a chair and walk 6 meters
- Clearly consciousness, able to read or use words to express and communicate without difficulty
- Agree and accept the study plan
Key exclusion criteria (6 listed)
- Acute and chronic inflammatory disease of the intestine within 3 months
- Use of antibiotics, probiotics, prebiotics or synthetics, laxatives or diarrhea medications, proton pump inhibitors or gastric motility drugs within 1 month
- Dementia
- mental illness or blindness
- acute infection
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 |
|---|---|---|
| InulinInulin 15 grams after dissolution by mouth， every morning for three months. | Dietary supplement | exprimental: Inulin |
| MaltodextrinAlso: PlaceboPlacebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution | Dietary supplement | Active comparator: maltodextrin |
Primary outcome
Improvement of frailty
Time frame: 3 months
Frailty will be diagnosed according to Fried criteria
1 secondary outcome
Diversity analysis of intestinal flora
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Derived from this study: PubMed 39286985Yang J, Hou L, Wang A, Shang L, Jia X, Xu R, Wang X. Prebiotics improve frailty status in community-dwelling older individuals in a double-blind, randomized, controlled trial. J Clin Invest. 2024 Aug 6;134(18):e176507. doi: 10.1172/JCI176507.
- Individual participant dataSharing planned: No. We will not make individual participant data (IPD) available to other researchers in a few years.
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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.
Wang xiao ming study chair
Director of geriatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin and Maltodextrin in people with Frailty Syndrome, run by Xijing Hospital at 1 site in China.
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 6 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: status not confirmed, as of the sponsor's last update on 17 Jul 2024. 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 China. 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?
Results are not available in the source record.
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?
Improvement of frailty (time frame: 3 months). 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 NCT03995342, which also lists 1 linked publication.
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 17 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.