Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women

Phase 2

• Conditions: Frail Elderly Syndrome
• Interventions: Dietary Supplement: Fisetin; Drug: Placebo oral capsule

• Registration Number: NCT03430037
• Lead Sponsor: Mayo Clinic

Brief Summary

This is a pilot study to evaluate whether targeting inflammation will help reduce markers of insulin resistance inflammation, bone resorption and physical dysfunction in elderly women with gait disturbance. Positive results of this study would lead to the development of a larger clinical trial examining the effects of this intervention on age-related dysfunction.

Detailed Description

To the researchers' knowledge, there are no published studies utilizing Fisetin in alteration of frailty markers. Several studies involve use of Fisetin for its anti-oxidative and anti-apoptotic effects in animal models. Fisetin may reduce oxidative stress, alleviate hyperglycemia, and improve kidney function. No one has evaluated the biologic markers of inflammation and frailty in older postmenopausal women. The researchers plan to evaluate markers of frailty and markers of inflammation, insulin resistance, and bone resorption while maintaining bone formation in older postmenopausal women.

Study Timeline

• Study First Submitted: 2018-02-05
• Study Start: 2018-02-06
• Study First Submitted QC: 2018-02-09
• Study First Posted: 2018-02-12
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-21
• Last Update Posted: 2024-11-25
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Fisetin	Fisetin 20/mg/kg/day, orally for 2 consecutive days, for 2 consecutive months.
Placebo	Placebo oral capsule	Placebo capsules orally for 2 consecutive days, for 2 consecutive months.

Primary Outcome Measures

Name	Time	Method
Improved 6 minute walk	One Month	Improved gait speed

Trial Locations

Locations (1)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States