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Quercetin's Effect on Bone Health and Inflammatory Markers

Primary Purpose

Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Quercetin (500 mg)
Placebo (500 mg)
Sponsored by
Kennesaw State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteoporosis, Postmenopausal focused on measuring Bone turnover markers, Quercetin

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Kennesaw State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Postmenopausal women: Experimental group

Postmenopausal women: Placebo group

Arm Description

Quercetin 500 mg. One capsule once a day.

Placebo (methylcellulose E4M) 500 mg, once capsule once a day.

Outcomes

Primary Outcome Measures

Osteocalcin ng/mL
Bone formation marker
PINP ug/L
Procollagen type-I N-terminal propeptide. Bone formation marker.
CTX ng/L
Type-I collagen cross-linked C-terminal telopeptide. Bone resorption marker.
IL-6 pg/mL
Interleukin-6 inflammatory marker.
TNF-alpha pg/mL
Tumor necrosis factor-alpha inflammatory marker
CRP mg/L
C-reactive protein inflammatory marker.
FBG mg/dl
Fasting blood glucose
BMD g/cm^2
Total, lumbar, right and left femur, and left forearm bone mineral density

Secondary Outcome Measures

Body composition
body fat percentage
Timed up and go (seconds)
Physical function test
Dominant handgrip strength (kg)
Physical function test

Full Information

First Posted
May 3, 2022
Last Updated
May 7, 2022
Sponsor
Kennesaw State University
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1. Study Identification

Unique Protocol Identification Number
NCT05371340
Brief Title
Quercetin's Effect on Bone Health and Inflammatory Markers
Official Title
The Efficacy of Quercetin Supplementation on Bone Turnover Markers, Inflammatory Markers, Body Composition, and Physical Function in Post-Menopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 27, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
April 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kennesaw State University

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis, Postmenopausal
Keywords
Bone turnover markers, Quercetin

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double blind placebo controlled
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Postmenopausal women: Experimental group
Arm Type
Experimental
Arm Description
Quercetin 500 mg. One capsule once a day.
Arm Title
Postmenopausal women: Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo (methylcellulose E4M) 500 mg, once capsule once a day.
Intervention Type
Dietary Supplement
Intervention Name(s)
Quercetin (500 mg)
Intervention Description
Once-daily 500 mg Quercetin
Intervention Type
Other
Intervention Name(s)
Placebo (500 mg)
Intervention Description
Once-daily 500 mg methylcellulose 9E4M)
Primary Outcome Measure Information:
Title
Osteocalcin ng/mL
Description
Bone formation marker
Time Frame
90-days
Title
PINP ug/L
Description
Procollagen type-I N-terminal propeptide. Bone formation marker.
Time Frame
90-days
Title
CTX ng/L
Description
Type-I collagen cross-linked C-terminal telopeptide. Bone resorption marker.
Time Frame
90-days
Title
IL-6 pg/mL
Description
Interleukin-6 inflammatory marker.
Time Frame
90-days
Title
TNF-alpha pg/mL
Description
Tumor necrosis factor-alpha inflammatory marker
Time Frame
90-days
Title
CRP mg/L
Description
C-reactive protein inflammatory marker.
Time Frame
90-days
Title
FBG mg/dl
Description
Fasting blood glucose
Time Frame
90-days
Title
BMD g/cm^2
Description
Total, lumbar, right and left femur, and left forearm bone mineral density
Time Frame
90-days
Secondary Outcome Measure Information:
Title
Body composition
Description
body fat percentage
Time Frame
90-days
Title
Timed up and go (seconds)
Description
Physical function test
Time Frame
90-days
Title
Dominant handgrip strength (kg)
Description
Physical function test
Time Frame
90-days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Kennesaw State University
City
Kennesaw
State/Province
Georgia
ZIP/Postal Code
30144
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Quercetin's Effect on Bone Health and Inflammatory Markers

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