Quercetin's Effect on Bone Health and Inflammatory Markers

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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis, Postmenopausal
• Intervention / Treatment: Dietary supplement: Quercetin (500 mg); Other: Placebo (500 mg)

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • Kennesaw State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Postmenopausal women: Experimental group; Quercetin 500 mg. One capsule once a day.	Dietary supplement: Quercetin (500 mg); Once-daily 500 mg Quercetin
Placebo Comparator: Postmenopausal women: Placebo group; Placebo (methylcellulose E4M) 500 mg, once capsule once a day.	Other: Placebo (500 mg); Once-daily 500 mg methylcellulose 9E4M)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	body fat percentage	90-days
Timed up and go (seconds)	Physical function test	90-days
Dominant handgrip strength (kg)	Physical function test	90-days

Collaborators and Investigators

• Sponsor: Kennesaw State University

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2019
• Primary Completion (Actual): April 27, 2020
• Study Completion (Actual): April 27, 2020

Study Registration Dates

• First Submitted: May 3, 2022
• First Submitted That Met QC Criteria: May 7, 2022
• First Posted (Actual): May 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 7, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Quercetin; Bone turnover markers
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; Quercetin
• Other Study ID Numbers: 19-476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No