NCT05371340

Brief Summary

Quercetin is a plant-based flavonoid that is naturally found in many fruits and vegetables, and is considered to be a potent antioxidant with several expected health benefits such as anti-inflammatory effects and bone-conserving properties. Participants will supplement with either Quercetin, or placebo, for 90-days with pre- and post-testing visits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 27, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2020

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

8 months

First QC Date

May 3, 2022

Last Update Submit

May 7, 2022

Conditions

Osteoporosis, Postmenopausal

Keywords

Bone turnover markersQuercetin

Outcome Measures

Primary Outcomes (8)

  • Osteocalcin ng/mL

    Bone formation marker

    90-days

  • PINP ug/L

    Procollagen type-I N-terminal propeptide. Bone formation marker.

    90-days

  • CTX ng/L

    Type-I collagen cross-linked C-terminal telopeptide. Bone resorption marker.

    90-days

  • IL-6 pg/mL

    Interleukin-6 inflammatory marker.

    90-days

  • TNF-alpha pg/mL

    Tumor necrosis factor-alpha inflammatory marker

    90-days

  • CRP mg/L

    C-reactive protein inflammatory marker.

    90-days

  • FBG mg/dl

    Fasting blood glucose

    90-days

  • BMD g/cm^2

    Total, lumbar, right and left femur, and left forearm bone mineral density

    90-days

Secondary Outcomes (3)

  • Body composition

    90-days

  • Timed up and go (seconds)

    90-days

  • Dominant handgrip strength (kg)

    90-days

Study Arms (2)

Postmenopausal women: Experimental group

EXPERIMENTAL

Quercetin 500 mg. One capsule once a day.

Dietary Supplement: Quercetin (500 mg)

Postmenopausal women: Placebo group

PLACEBO COMPARATOR

Placebo (methylcellulose E4M) 500 mg, once capsule once a day.

Other: Placebo (500 mg)

Interventions

Quercetin (500 mg)DIETARY_SUPPLEMENT

Once-daily 500 mg Quercetin

Postmenopausal women: Experimental group
Placebo (500 mg)OTHER

Once-daily 500 mg methylcellulose 9E4M)

Postmenopausal women: Placebo group

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically defined as postmenopausal (absence of menstrual cycle for 12 months without contraceptives or the surgical removal of the reproductive organs)
  • Activity levels ranging from sedentary to recreationally active were included in the study.

You may not qualify if:

  • Hyper- or hypothyroidism (uncontrolled)
  • Hyper- or hypoparathyroidism
  • Gastrointestinal disorders
  • Renal disorders
  • Orthopedic disorders
  • Rheumatological disorders
  • Immunological disorders
  • Type I diabetic
  • Being treated with any diabetic injectable medication(s).
  • Taking any non-steroidal, steroidal, or anti-inflammatory drugs
  • Currently, or in the past 1 month, were consuming daily calcium
  • Currently, or in the past 1 month, were consuming more than 5,000 IU's of vitamin D supplements
  • Taking any anti-obesity medications
  • Taking any osteoporotic medication(s)
  • Taking any long-term antibiotics.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennesaw State University

Kennesaw, Georgia, 30144, United States

Location

Related Publications (1)

  • Bailly AR, Hester GM, Alesi MG, Buresh RJ, Feito Y, Mermier CM, Ducharme JB, VanDusseldorp TA. Quercetins efficacy on bone and inflammatory markers, body composition, and physical function in postmenopausal women. J Bone Miner Metab. 2025 May;43(3):304-314. doi: 10.1007/s00774-025-01592-0. Epub 2025 Mar 7.

    PMID: 40053115DERIVED

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Interventions

Quercetin

Condition Hierarchy (Ancestors)

OsteoporosisBone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Double blind placebo controlled
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

May 3, 2022

First Posted

May 12, 2022

Study Start

August 27, 2019

Primary Completion

April 27, 2020

Study Completion

April 27, 2020

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)