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

Air Force Military Medical University of People's Liberation Army

Status: Invitation-only

Conditions: Frailty Syndrome

Treatments: Dietary Supplement: Inulin; Dietary Supplement: Maltodextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT03995342

KY20192015-F-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

exprimental: Inulin

Experimental group

Description:

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

Treatment:

Dietary Supplement: Inulin

Active comparator: maltodextrin

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Maltodextrin