OsteopeniaOsTeaNCT03480126
Herbal Teas on Bone Health in an Osteopenic Population
A study testing Herbal Teas in people with Osteopenia, run by Paula Witt-Enderby at 1 site in United States.
Trial summary
The project goal is to identify if herbal teas consumed three times per day over a period of three months can improve these markers of bone health as well as improve quality of life (QOL) compared to women taking placebo by increasing osteoblast activity, decreasing osteoclast activity, increasing nocturnal melatonin… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteopenia
- What is being tested?
- Herbal Teas
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2018to 27 Aug 2019
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- male or female with osteopenia (T-score between -1.0 and -2.5)
- at least 18 years of age
- must be willing to drink tea three times a day for 3 months
- must also be willing to come to the study location on 4 occasions (baseline, end of month 1, end of month 2, and end of month 3),
- must also be willing to come to the study location to provide urinary, salivary and fecal samples on 2 occasions (baseline and at the end of month 3),
- must also be willing to come to the study location to have their blood pressure taken on 4 occasions (baseline, end of month 1, end of month 2, and end of month 3)
- must be willing to come to the study location to complete questionnaires on 2 occasions (baseline and at the end of month 3)
- must be willing to maintain daily diary for 4 months.
Who cannot join
- Women or men with osteoporosis
- Women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use
- Women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators, hormone therapy, teriparatide, and denosumab)
- Women or men with chronic obstructive pulmonary disease (COPD)
- Women or men who smoke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Efficacy of Herbal Teas on Bone Health in an Osteopenic Population: OsTea
The project goal is to identify if herbal teas consumed three times per day over a period of three months can improve these markers of bone health as well as improve quality of life (QOL) compared to women taking placebo by increasing osteoblast activity, decreasing osteoclast activity, increasing nocturnal melatonin levels and by decreasing C-reactive protein (CRP) and cortisol levels. Our central hypothesis is that these herbal teas will improve both objective and subjective measures of bone health in a population with osteopenia not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by reducing stress and anxiety.
- Conditions
- Osteopenia
- Being tested
- Herbal Teas
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Herbal TeasOther
Steeped tea ingested 3 times a day for 3 mos
| Study group | Role | What they receive |
|---|---|---|
| Herbal Tea 1 | Placebo comparator | Placebo Tea should will be ingested 3 times per day for 3 months Receives: Other: Herbal Teas |
| Herbal Tea 2 | Experimental | Experimental Herbal Tea A will be ingested 3 times per day for 3 months Receives: Other: Herbal Teas |
| Herbal Tea 3 | Experimental | Experimental Herbal Tea B will be ingested 3 times per day for 3 months Receives: Other: Herbal Teas |
| Herbal Tea 4 | Experimental | Experimental Herbal Tea C will be ingested 3 times per day for 3 months Receives: Other: Herbal Teas |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels
Urinary CTx levels will be measured at times month 0 (baseline) and month 3
Measured: 3 months
The Effect of 3 month Herbal Tea on Changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels
Urinary P1NP levels will be measured at times month 0 (baseline) and month 3
Measured: 3 months
The Effect of 3 month Herbal Tea on Changes in the Ratio of CTx:P1NP
Urinary CTx:P1NP levels will be measured at times month 0 (baseline) and month 3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start1 Jun 2018
- Primary completion27 Aug 2019
- Study completion27 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paula Witt-Enderby
- Sponsor type
- University, hospital or other
- Collaborators
- Duquesne University
- Responsible party
- Sponsor-investigator, Paula Witt-Enderby, Duquesne University
- Investigators
- Paula A Witt-Enderby, PhD, Principal investigator, Duquesne University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03480126
- Sponsor's protocol ID
- 2018/02/7
- Acronym
- OsTea
- Status last verified
- Dec 2021
- First submitted
- 28 Feb 2018
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Herbal Teas on Bone Health in an Osteopenic Population: OsTea
- ClinicalTrials.gov ID
- NCT03480126
- Acronym / sponsor ID
- OsTea / 2018/02/7
- Conditions
- Osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Paula Witt-EnderbyUniversity, hospital or other
- Collaborators
- Duquesne University
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 27 Aug 2019 (actual)
- First posted
- 29 Mar 2018 (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.
The project goal is to identify if herbal teas consumed three times per day over a period of three months can improve these markers of bone health as well as improve quality of life (QOL) compared to women taking placebo by increasing osteoblast activity, decreasing osteoclast activity, increasing nocturnal melatonin levels and by decreasing C-reactive protein (CRP) and cortisol levels. Our central hypothesis is that these herbal teas will improve both objective and subjective measures of bone health in a population with osteopenia not taking this regimen by reducing osteoclast activity and increasing osteoblast activity and by reducing stress and anxiety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Herbal Tea 1 | Placebo comparator | Other: Herbal TeasPlacebo Tea should will be ingested 3 times per day for 3 months |
| Herbal Tea 2 | Experimental | Other: Herbal TeasExperimental Herbal Tea A will be ingested 3 times per day for 3 months |
| Herbal Tea 3 | Experimental | Other: Herbal TeasExperimental Herbal Tea B will be ingested 3 times per day for 3 months |
| Herbal Tea 4 | Experimental | Other: Herbal TeasExperimental Herbal Tea C will be ingested 3 times per day for 3 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- male or female with osteopenia (T-score between -1.0 and -2.5)
- at least 18 years of age
- must be willing to drink tea three times a day for 3 months
- must also be willing to come to the study location on 4 occasions (baseline, end of month 1, end of month 2, and end of month 3),
- must also be willing to come to the study location to provide urinary, salivary and fecal samples on 2 occasions (baseline and at the end of month 3),
Key exclusion criteria (5 listed)
- Women or men with osteoporosis
- Women or men with osteopenia due to hyperparathyroidism, multiple myeloma, metastatic bone disease, chronic steroid use
- Women or men who are on any bone therapies (i.e. bisphosphonates, selective estrogen receptor modulators, hormone therapy, teriparatide, and denosumab)
- Women or men with chronic obstructive pulmonary disease (COPD)
- Women or men who smoke
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 |
|---|---|---|
| Herbal TeasSteeped tea ingested 3 times a day for 3 mos | Other | Herbal Tea 1, Herbal Tea 2, Herbal Tea 3, Herbal Tea 4 |
Primary outcome
The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels
Time frame: 3 months
Urinary CTx levels will be measured at times month 0 (baseline) and month 3
The Effect of 3 month Herbal Tea on Changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels
Time frame: 3 months
Urinary P1NP levels will be measured at times month 0 (baseline) and month 3
The Effect of 3 month Herbal Tea on Changes in the Ratio of CTx:P1NP
Time frame: 3 months
Urinary CTx:P1NP levels will be measured at times month 0 (baseline) and month 3
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 11 Jan 2022.
- Study assessing the efficacy of herbal teas on bone health and quality of life in a population with osteopenia: rooibos actions on melatonin and tulsi actions on quality of life.Link provided by the sponsor.
- 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.
Paula A Witt-Enderby, PhD principal investigator
Duquesne University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Herbal Teas in people with Osteopenia, run by Paula Witt-Enderby 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 8 inclusion and 5 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 11 Jan 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?
The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2022.