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

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.

Study Overview

• Status: Completed
• Conditions: Osteopenia
• Intervention / Treatment: Other: Herbal Teas

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15282
      • Duquesne University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Herbal Tea 1; Placebo Tea should will be ingested 3 times per day for 3 months	Other: Herbal Teas; Steeped tea ingested 3 times a day for 3 mos
Experimental: Herbal Tea 2; Experimental Herbal Tea A will be ingested 3 times per day for 3 months	Other: Herbal Teas; Steeped tea ingested 3 times a day for 3 mos
Experimental: Herbal Tea 3; Experimental Herbal Tea B will be ingested 3 times per day for 3 months	Other: Herbal Teas; Steeped tea ingested 3 times a day for 3 mos
Experimental: Herbal Tea 4; Experimental Herbal Tea C will be ingested 3 times per day for 3 months	Other: Herbal Teas; Steeped tea ingested 3 times a day for 3 mos

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	3 months

Collaborators and Investigators

• Sponsor: Paula Witt-Enderby
• Collaborators: Duquesne University
• Investigators: Principal Investigator: Paula A Witt-Enderby, PhD, Duquesne University

Publications and helpful links

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): August 27, 2019
• Study Completion (Actual): August 27, 2019

Study Registration Dates

• First Submitted: February 28, 2018
• First Submitted That Met QC Criteria: March 20, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic
• Other Study ID Numbers: 2018/02/7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No