NCT03430037

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
17mo left

Started Feb 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Feb 2018Nov 2027

First Submitted

Initial submission to the registry

February 5, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

February 6, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2018

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

8.7 years

First QC Date

February 5, 2018

Last Update Submit

May 7, 2026

Conditions

Frail Elderly Syndrome

Keywords

InflammationFrailty

Outcome Measures

Primary Outcomes (1)

  • Improved 6 minute walk

    Improved gait speed

    One Month

Study Arms (2)

Treatment

EXPERIMENTAL

Fisetin 20/mg/kg/day, orally for 2 consecutive days, for 2 consecutive months.

Dietary Supplement: Fisetin

Placebo

PLACEBO COMPARATOR

Placebo capsules orally for 2 consecutive days, for 2 consecutive months.

Drug: Placebo oral capsule

Interventions

FisetinDIETARY_SUPPLEMENT

Flavonoid Family

Treatment
Placebo oral capsuleDRUG

Placebo

Also known as: Placebo
Placebo

Eligibility Criteria

Age70 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Healthy postmenopausal women
  • Age ≥ 70 years

You may not qualify if:

  • Abnormality in any of the screening laboratory studies (see below)
  • Presence of significant liver or renal disease
  • Malignancy (including myeloma)
  • Malabsorption
  • Hypoparathyroidism
  • Hyperparathyroidism
  • Acromegaly
  • Cushing's syndrome
  • Hypopituitarism
  • Gastric bypass/reduction
  • Malabsorption issues
  • Crohn's
  • Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinase or ESR)
  • If diabetic AND on sulfonylureas (like glipizide, glimepiride, glyburide), SGLT2 inhibitors (like dapagliflozin and empagliflozin), or insulin
  • Undergoing treatment with any medications that affect bone turnover, including the following:
  • +19 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

InflammationFrailty

Interventions

fisetin

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Robert J Pignolo, MD, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Sundeep Khosla, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 5, 2018

First Posted

February 12, 2018

Study Start

February 6, 2018

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2027

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)