Herbal Teas on Bone Health in an Osteopenic Population

NCT ID: NCT03480126

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2019-08-27

Brief Summary

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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.

Detailed Description

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Conditions

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Osteopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Herbal Tea 1

Placebo Tea should will be ingested 3 times per day for 3 months

Group Type PLACEBO_COMPARATOR

Herbal Teas

Intervention Type OTHER

Steeped tea ingested 3 times a day for 3 mos

Herbal Tea 2

Experimental Herbal Tea A will be ingested 3 times per day for 3 months

Group Type EXPERIMENTAL

Herbal Teas

Intervention Type OTHER

Steeped tea ingested 3 times a day for 3 mos

Herbal Tea 3

Experimental Herbal Tea B will be ingested 3 times per day for 3 months

Group Type EXPERIMENTAL

Herbal Teas

Intervention Type OTHER

Steeped tea ingested 3 times a day for 3 mos

Herbal Tea 4

Experimental Herbal Tea C will be ingested 3 times per day for 3 months

Group Type EXPERIMENTAL

Herbal Teas

Intervention Type OTHER

Steeped tea ingested 3 times a day for 3 mos

Interventions

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Herbal Teas

Steeped tea ingested 3 times a day for 3 mos

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duquesne University

OTHER

Sponsor Role collaborator

Paula Witt-Enderby

OTHER

Sponsor Role lead

Responsible Party

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Paula Witt-Enderby

Professor of Pharmacology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Paula A Witt-Enderby, PhD

Role: PRINCIPAL_INVESTIGATOR

Duquesne University

Locations

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Duquesne University

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Related Links

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https://www.melatonin-research.net/index.php/MR/article/view/135/778

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.

Other Identifiers

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2018/02/7

Identifier Type: -

Identifier Source: org_study_id

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