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Herbal Teas on Bone Health in an Osteopenic Population (OsTea)

Primary Purpose

Osteopenia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Herbal Teas
Sponsored by
Paula Witt-Enderby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Osteopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duquesne University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Herbal Tea 1

Herbal Tea 2

Herbal Tea 3

Herbal Tea 4

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
February 28, 2018
Last Updated
December 22, 2021
Sponsor
Paula Witt-Enderby
Collaborators
Duquesne University
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1. Study Identification

Unique Protocol Identification Number
NCT03480126
Brief Title
Herbal Teas on Bone Health in an Osteopenic Population
Acronym
OsTea
Official Title
Assessing the Efficacy of Herbal Teas on Bone Health in an Osteopenic Population: OsTea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
August 27, 2019 (Actual)
Study Completion Date
August 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paula Witt-Enderby
Collaborators
Duquesne University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Herbal Tea 1
Arm Type
Placebo Comparator
Arm Description
Placebo Tea should will be ingested 3 times per day for 3 months
Arm Title
Herbal Tea 2
Arm Type
Experimental
Arm Description
Experimental Herbal Tea A will be ingested 3 times per day for 3 months
Arm Title
Herbal Tea 3
Arm Type
Experimental
Arm Description
Experimental Herbal Tea B will be ingested 3 times per day for 3 months
Arm Title
Herbal Tea 4
Arm Type
Experimental
Arm Description
Experimental Herbal Tea C will be ingested 3 times per day for 3 months
Intervention Type
Other
Intervention Name(s)
Herbal Teas
Intervention Description
Steeped tea ingested 3 times a day for 3 mos
Primary Outcome Measure Information:
Title
The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels
Description
Urinary CTx levels will be measured at times month 0 (baseline) and month 3
Time Frame
3 months
Title
The Effect of 3 month Herbal Tea on Changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels
Description
Urinary P1NP levels will be measured at times month 0 (baseline) and month 3
Time Frame
3 months
Title
The Effect of 3 month Herbal Tea on Changes in the Ratio of CTx:P1NP
Description
Urinary CTx:P1NP levels will be measured at times month 0 (baseline) and month 3
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paula A Witt-Enderby, PhD
Organizational Affiliation
Duquesne University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duquesne University
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15282
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.melatonin-research.net/index.php/MR/article/view/135/778
Description
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.

Learn more about this trial

Herbal Teas on Bone Health in an Osteopenic Population

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