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Clinical Trials/NCT05371340
NCT05371340CompletedNot Applicable

The Efficacy of Quercetin Supplementation on Bone Turnover Markers, Inflammatory Markers, Body Composition, and Physical Function in Post-Menopausal Women

Kennesaw State University2 sites in 1 country33 target enrollmentStarted: August 27, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
33
Locations
2
Primary Endpoint
CRP mg/L

Study Overview

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.

Detailed Description

Quercetin is a plant-based flavonoid that is naturally found in many fruits and vegetables such as onions, apples, berries, green tea, and red wine and is currently an FDA approved supplement. Quercetin is considered to be a potent antioxidant with several expected health benefits. Both in vivo and in vitro studies have demonstrated that quercetin acts as a potent natural osteogenic agent with benefits that include anti-inflammatory effects and bone-conserving properties. Quercetin is suggested to protect against bone loss by inhibiting bone resorption and stimulating bone formation which is indicated by an increase in bone mineral density and bone formation markers such as osteocalcin.

The purpose of this study is to investigate the effects of quercetin supplementation on bone, specifically on bone turnover markers, in postmenopausal women. The interplay between cytokines (i.e., IL-6, CRP, and TNF-alpha) and bone turnover markers was also considered.

In a double-blind, placebo-controlled fashion, we aimed to recruit 50, healthy, postmenopausal women between the ages of 45-75 years to participate in a 90-day supplement trial. Participants will be randomly assigned to one of two supplement groups: 1) quercetin 500 mg, once per day, or 2) placebo (methyl cellulose E4M) 500 mg, once per day for 90-days.

Participants will be asked to visit the laboratory (KSU Human Performance Laboratory) on 2 separate occasions for pre- and post-testing visits consisting of body composition measurements and blood draws by a CITI approved/IRB approved research team member trained in phlebotomy under the supervision of Dr. VanDusseldorp.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
45 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.
  • Current smoker
  • Diagnosed with osteoporosis, or if their BMD was equal to, or fell below -2.50 via dual x-ray absorptiometry (DXA) during visit 1
  • Involved in heavy resistance training
  • Began a new unaccustomed exercise routine during the 90-days
  • Allergies to food(s) rich in QUE such as onions, apples, or berries; or if they were unwilling to avoid quercetin-containing foods.

Outcomes

Primary Outcomes

CRP mg/L

Time Frame: 90-days

C-reactive protein inflammatory marker.

BMD g/cm^2

Time Frame: 90-days

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

Osteocalcin ng/mL

Time Frame: 90-days

Bone formation marker

TNF-alpha pg/mL

Time Frame: 90-days

Tumor necrosis factor-alpha inflammatory marker

FBG mg/dl

Time Frame: 90-days

Fasting blood glucose

CTX ng/L

Time Frame: 90-days

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

PINP ug/L

Time Frame: 90-days

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

IL-6 pg/mL

Time Frame: 90-days

Interleukin-6 inflammatory marker.

Secondary Outcomes

  • Timed up and go (seconds)(90-days)
  • Dominant handgrip strength (kg)(90-days)
  • Body composition(90-days)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Trisha VanDusseldorp

Director

Kennesaw State University

Study Sites (2)

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