Herbal Teas on Bone Health in an Osteopenic Population

Osteopenia Clinical Trial

— OsTea  

Official title:

Assessing the Efficacy of Herbal Teas on Bone Health in an Osteopenic Population: OsTea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03480126
• Other study ID #: 2018/02/7
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: August 27, 2019

Study information

• Verified date: December 2021
• Source: Duquesne University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 27, 2019
• Est. primary completion date: August 27, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Diseases, Metabolic
• Osteopenia

Intervention

Other:
• Herbal Teas
Steeped tea ingested 3 times a day for 3 mos

Locations

Country	Name	City	State
United States	Duquesne University	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Paula Witt-Enderby	Duquesne University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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

External 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.