NCT03995342

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Inulin	Inulin 15 grams after dissolution by mouth， every morning for three months.
DIETARY_SUPPLEMENT	Maltodextrin	Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution

Timeline

• Start date: 2019-08-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-06-24
• Last updated: 2024-07-17

Locations

1 site across 1 country: China