Frailty Syndrome
Conditions
Keywords
frailty, flora
Brief 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.
Interventions
DIETARY_SUPPLEMENTInulin
Inulin 15 grams after dissolution by mouth， every morning for three months.
DIETARY_SUPPLEMENTMaltodextrin
Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution
Sponsors
Xijing Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of frailty | 3 months | Frailty will be diagnosed according to Fried criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diversity analysis of intestinal flora | 3 months | Change of diversity analysis of intestinal flora |
Countries
China
Outcome results
None listed