OsTea: Herbal Teas on Bone Health in an Osteopenic Population

• Sponsor: Paula Witt-Enderby (Other)
• Overall Status: Completed
• CT.gov ID: NCT03480126
• Collaborator: Duquesne University (Other)
• Enrollment: 35
• Location: 1
• Arms: 4
• Actual Duration (Months): 14.9
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Osteopenia	Other: Herbal Teas	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Assessing the Efficacy of Herbal Teas on Bone Health in an Osteopenic Population: OsTea
• Actual Study Start Date: Jun 1, 2018
• Actual Primary Completion Date: Aug 27, 2019
• Actual Study Completion Date: Aug 27, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The Effect of 3 month Herbal Tea on Changes in Human Type 1 Collagen C-telopeptide (CTx) levels [3 months]

   Urinary CTx levels will be measured at times month 0 (baseline) and month 3

2. The Effect of 3 month Herbal Tea on Changes in Human Procollagen Type 1 Intact N-terminal Propeptide (Total P1NP) levels [3 months]

   Urinary P1NP levels will be measured at times month 0 (baseline) and month 3

3. The Effect of 3 month Herbal Tea on Changes in the Ratio of CTx:P1NP [3 months]

   Urinary CTx:P1NP levels will be measured at times month 0 (baseline) and month 3

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duquesne University	Pittsburgh	Pennsylvania	United States	15282

Sponsors and Collaborators

• Paula Witt-Enderby
• Duquesne University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

None provided.

• Responsible Party: Paula Witt-Enderby, Professor of Pharmacology, Duquesne University
• ClinicalTrials.gov Identifier: NCT03480126
• Other Study ID Numbers: 2018/02/7
• First Posted: Mar 29, 2018
• Last Update Posted: Jan 11, 2022
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bone Diseases, Metabolic

Study Results

No Results Posted as of Jan 11, 2022