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Completed

NCT Number: NCT05371340

Quercetin's Effect on Bone Health and Inflammatory Markers

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.

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Key information

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kennesaw State University

Kennesaw, Georgia, 30144, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Quercetin (500 mg)

Dietary Supplement

Once-daily 500 mg Quercetin

Placebo (500 mg)

Other

Once-daily 500 mg methylcellulose 9E4M)

Primary outcomes

  1. Osteocalcin ng/mL

    Time frame: 90-days

    Bone formation marker

  2. PINP ug/L

    Time frame: 90-days

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

  3. CTX ng/L

    Time frame: 90-days

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

  4. IL-6 pg/mL

    Time frame: 90-days

    Interleukin-6 inflammatory marker.

  5. TNF-alpha pg/mL

    Time frame: 90-days

    Tumor necrosis factor-alpha inflammatory marker

  6. CRP mg/L

    Time frame: 90-days

    C-reactive protein inflammatory marker.

  7. FBG mg/dl

    Time frame: 90-days

    Fasting blood glucose

  8. BMD g/cm^2

    Time frame: 90-days

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

Secondary outcomes

  1. Body composition

    Time frame: 90-days

    body fat percentage

  2. Timed up and go (seconds)

    Time frame: 90-days

    Physical function test

  3. Dominant handgrip strength (kg)

    Time frame: 90-days

    Physical function test

Sponsors and collaborators

Lead sponsor

Kennesaw State University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 12, 2022
Registry last updated
May 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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