Quercetin's Effect on Bone Health and Inflammatory Markers

• Sponsor: Kennesaw State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05371340
• Collaborator: (none)
• Enrollment: 33
• Location: 1
• Arms: 2
• Actual Duration (Months): 8
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis, Postmenopausal	Dietary Supplement: Quercetin (500 mg); Other: Placebo (500 mg)	N/A

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
• Actual Enrollment: 33 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Double blind placebo controlledDouble blind placebo controlled
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Efficacy of Quercetin Supplementation on Bone Turnover Markers, Inflammatory Markers, Body Composition, and Physical Function in Post-Menopausal Women
• Actual Study Start Date: Aug 27, 2019
• Actual Primary Completion Date: Apr 27, 2020
• Actual Study Completion Date: Apr 27, 2020

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Osteocalcin ng/mL [90-days]

   Bone formation marker

2. PINP ug/L [90-days]

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

3. CTX ng/L [90-days]

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

4. IL-6 pg/mL [90-days]

   Interleukin-6 inflammatory marker.

5. TNF-alpha pg/mL [90-days]

   Tumor necrosis factor-alpha inflammatory marker

6. CRP mg/L [90-days]

   C-reactive protein inflammatory marker.

7. FBG mg/dl [90-days]

   Fasting blood glucose

8. BMD g/cm^2 [90-days]

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

Secondary Outcome Measures

1. Body composition [90-days]

   body fat percentage

2. Timed up and go (seconds) [90-days]

   Physical function test

3. Dominant handgrip strength (kg) [90-days]

   Physical function test

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years to 75 Years
• Sexes Eligible for Study: 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kennesaw State University	Kennesaw	Georgia	United States	30144

Sponsors and Collaborators

• Kennesaw State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Trisha VanDusseldorp, Director, Kennesaw State University
• ClinicalTrials.gov Identifier: NCT05371340
• Other Study ID Numbers: 19-476
• First Posted: May 12, 2022
• Last Update Posted: May 12, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Trisha VanDusseldorp, Director, Kennesaw State University: Bone turnover markers; Quercetin
• Additional relevant MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal; Quercetin

Study Results

No Results Posted as of May 12, 2022