The Correlation and Intervention of Intestinal Flora and Frailty in the Elderly

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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

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Frailty Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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exprimental: Inulin

Inulin 15 grams after dissolution by mouth， every morning for three months.

Group Type EXPERIMENTAL

Inulin

Intervention Type DIETARY_SUPPLEMENT

Inulin 15 grams after dissolution by mouth， every morning for three months.

Active comparator: maltodextrin

Placebo (maltodextrin) 15grams after dissolution by mouth， every morning for three months.

Group Type PLACEBO_COMPARATOR

Maltodextrin

Intervention Type DIETARY_SUPPLEMENT

Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution

Interventions

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Inulin

Inulin 15 grams after dissolution by mouth， every morning for three months.

Intervention Type DIETARY_SUPPLEMENT

Maltodextrin

Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No