Quercetin's Effect on Bone Health and Inflammatory Markers

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05371340
• Other study ID #: 19-476
• Status: Completed
• Phase: N/A
• Start date: August 27, 2019
• Est. completion date: April 27, 2020

Study information

• Verified date: May 2022
• Source: Kennesaw State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: April 27, 2020
• Est. primary completion date: April 27, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Osteoporosis
• Osteoporosis, Postmenopausal

Intervention

Dietary Supplement:
• Quercetin (500 mg)
Once-daily 500 mg Quercetin

Other:
• Placebo (500 mg)
Once-daily 500 mg methylcellulose 9E4M)

Locations

Country	Name	City	State
United States	Kennesaw State University	Kennesaw	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Kennesaw State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteocalcin ng/mL	Bone formation marker	90-days
Primary	PINP ug/L	Procollagen type-I N-terminal propeptide. Bone formation marker.	90-days
Primary	CTX ng/L	Type-I collagen cross-linked C-terminal telopeptide. Bone resorption marker.	90-days
Primary	IL-6 pg/mL	Interleukin-6 inflammatory marker.	90-days
Primary	TNF-alpha pg/mL	Tumor necrosis factor-alpha inflammatory marker	90-days
Primary	CRP mg/L	C-reactive protein inflammatory marker.	90-days
Primary	FBG mg/dl	Fasting blood glucose	90-days
Primary	BMD g/cm^2	Total, lumbar, right and left femur, and left forearm bone mineral density	90-days
Secondary	Body composition	body fat percentage	90-days
Secondary	Timed up and go (seconds)	Physical function test	90-days
Secondary	Dominant handgrip strength (kg)	Physical function test	90-days