Osteoporosis, PostmenopausalNCT05371340
Quercetin's Effect on Bone Health and Inflammatory Markers
A study testing Quercetin (500 mg) in people with Osteoporosis, Postmenopausal, run by Kennesaw State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Quercetin (500 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Aug 2019to 27 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Hyper- or hypothyroidism (uncontrolled)
- Hyper- or hypoparathyroidism
- Gastrointestinal disorders
- Renal disorders
- Orthopedic disorders
- Rheumatological disorders
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Quercetin (500 mg), Placebo (500 mg)
- Keywords
- Bone turnover markers, Quercetin
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quercetin (500 mg)Dietary supplement
Once-daily 500 mg Quercetin
Placebo (500 mg)Other
Once-daily 500 mg methylcellulose 9E4M)
| Study group | Role | What they receive |
|---|---|---|
| Postmenopausal women: Experimental group | Experimental | Quercetin 500 mg. One capsule once a day. Receives: Dietary Supplement: Quercetin (500 mg) |
| Postmenopausal women: Placebo group | Placebo comparator | Placebo (methylcellulose E4M) 500 mg, once capsule once a day. Receives: Other: Placebo (500 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Osteocalcin ng/mL
Bone formation marker
Measured: 90-days
PINP ug/L
Procollagen type-I N-terminal propeptide. Bone formation marker.
Measured: 90-days
CTX ng/L
Type-I collagen cross-linked C-terminal telopeptide. Bone resorption marker.
Measured: 90-days
IL-6 pg/mL
Interleukin-6 inflammatory marker.
Measured: 90-days
TNF-alpha pg/mL
Tumor necrosis factor-alpha inflammatory marker
Measured: 90-days
CRP mg/L
C-reactive protein inflammatory marker.
Measured: 90-days
FBG mg/dl
Fasting blood glucose
Measured: 90-days
BMD g/cm^2
Total, lumbar, right and left femur, and left forearm bone mineral density
Measured: 90-days
Secondary outcomes (3)
Body composition
body fat percentage
Measured: 90-days
Timed up and go (seconds)
Physical function test
Measured: 90-days
Dominant handgrip strength (kg)
Physical function test
Measured: 90-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start27 Aug 2019
- Primary completion27 Apr 2020
- Study completion27 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind placebo controlled
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kennesaw State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trisha VanDusseldorp, Kennesaw State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371340
- Sponsor's protocol ID
- 19-476
- Status last verified
- May 2022
- First submitted
- 3 May 2022
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bailly AR, Hester GM, Alesi MG, Buresh RJ, Feito Y, Mermier CM, Ducharme JB, VanDusseldorp TA. Quercetins efficacy on bone and inflammatory markers, body composition, and physical function in postmenopausal women. J Bone Miner Metab. 2025 May;43(3):304-314. doi: 10.1007/s00774-025-01592-0. Epub 2025 Mar 7.
PubMed 40053115
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Quercetin Supplementation on Bone Turnover Markers, Inflammatory Markers, Body Composition, and Physical Function in Post-Menopausal Women
- ClinicalTrials.gov ID
- NCT05371340
- Acronym / sponsor ID
- 19-476
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Bone turnover markers, Quercetin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Kennesaw State UniversityUniversity, hospital or other
- Study start
- 27 Aug 2019 (actual)
- Primary completion
- 27 Apr 2020 (actual)
- Study completion
- 27 Apr 2020 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Postmenopausal women: Experimental group | Experimental | Dietary Supplement: Quercetin (500 mg)Quercetin 500 mg. One capsule once a day. |
| Postmenopausal women: Placebo group | Placebo comparator | Other: Placebo (500 mg)Placebo (methylcellulose E4M) 500 mg, once capsule once a day. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (20 listed)
- Hyper- or hypothyroidism (uncontrolled)
- Hyper- or hypoparathyroidism
- Gastrointestinal disorders
- Renal disorders
- Orthopedic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quercetin (500 mg)Once-daily 500 mg Quercetin | Dietary supplement | Postmenopausal women: Experimental group |
| Placebo (500 mg)Once-daily 500 mg methylcellulose 9E4M) | Other | Postmenopausal women: Placebo group |
Primary outcome
Osteocalcin ng/mL
Time frame: 90-days
Bone formation marker
PINP ug/L
Time frame: 90-days
Procollagen type-I N-terminal propeptide. Bone formation marker.
CTX ng/L
Time frame: 90-days
Type-I collagen cross-linked C-terminal telopeptide. Bone resorption marker.
IL-6 pg/mL
Time frame: 90-days
Interleukin-6 inflammatory marker.
TNF-alpha pg/mL
Time frame: 90-days
Tumor necrosis factor-alpha inflammatory marker
CRP mg/L
Time frame: 90-days
C-reactive protein inflammatory marker.
FBG mg/dl
Time frame: 90-days
Fasting blood glucose
BMD g/cm^2
Time frame: 90-days
Total, lumbar, right and left femur, and left forearm bone mineral density
3 secondary outcomes
Body composition
Time frame: 90-days
Timed up and go (seconds)
Time frame: 90-days
Dominant handgrip strength (kg)
Time frame: 90-days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Derived from this study: PubMed 40053115Bailly AR, Hester GM, Alesi MG, Buresh RJ, Feito Y, Mermier CM, Ducharme JB, VanDusseldorp TA. Quercetins efficacy on bone and inflammatory markers, body composition, and physical function in postmenopausal women. J Bone Miner Metab. 2025 May;43(3):304-314. doi: 10.1007/s00774-025-01592-0. Epub 2025 Mar 7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quercetin (500 mg) in people with Osteoporosis, Postmenopausal, run by Kennesaw State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Osteocalcin ng/mL (time frame: 90-days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05371340, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.