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

NCT03995342 | Enrolling By Invitation

• 1 other identifier: KY20192015-F-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Frailty Syndrome

Keywords

frailty, flora

Outcome Measures

Primary Outcomes (1)

• Improvement of frailty

  Frailty will be diagnosed according to Fried criteria

  3 months

Secondary Outcomes (1)

• Diversity analysis of intestinal flora

  3 months

Study Arms (2)

exprimental: Inulin

EXPERIMENTAL

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

Dietary Supplement: Inulin

Active comparator: maltodextrin

PLACEBO COMPARATOR

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

Dietary Supplement: Maltodextrin

Interventions

Inulin DIETARY_SUPPLEMENT

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

exprimental: Inulin

Maltodextrin DIETARY_SUPPLEMENT

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

Also known as: Placebo

Active comparator: maltodextrin

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 39286985 DERIVED

MeSH Terms

Conditions

Frailty

Interventions

Inulin; maltodextrin

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Starch; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Fructans; Polysaccharides

Study Officials

• Wang xiao ming

  Director of geriatrics

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of geriatrics

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 24, 2019
• Study Start: August 1, 2019
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: July 17, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)