Quercetin's Effect on Bone Health and Inflammatory Markers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Osteoporosis, Postmenopausal

Intervention / Treatment
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* Dietary Supplement: Quercetin (500 mg)
* Other: Placebo (500 mg)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind placebo controlled
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone turnover markers, Quercetin