Herbal Teas on Bone Health in an Osteopenic Population

NCT03480126 — Not applicable, Completed, 35 participants, Paula Witt-Enderby

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

Registry	NCT03480126, acronym OsTea
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: double, prevention
Enrollment	35 (Actual)
Sponsor	Paula Witt-Enderby (Other); collaborators: Duquesne University
Conditions	Osteopenia
Interventions	Herbal Teas (Other)
Dates	start 2018-06-01, primary completion 2019-08-27, completion 2019-08-27, first posted 2018-03-29, last updated 2022-01-11
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Herbal Tea 1	Placebo comparator	Other: Herbal Teas	Placebo Tea should will be ingested 3 times per day for 3 months
Herbal Tea 2	Experimental	Other: Herbal Teas	Experimental Herbal Tea A will be ingested 3 times per day for 3 months
Herbal Tea 3	Experimental	Other: Herbal Teas	Experimental Herbal Tea B will be ingested 3 times per day for 3 months
Herbal Tea 4	Experimental	Other: Herbal Teas	Experimental Herbal Tea C will be ingested 3 times per day for 3 months

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

+Outcome measures

Primary outcomes

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
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
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

Sex: All, ages: 18 Years to any, accepts 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

+Locations (1)

Facility	City	Country	Status
Duquesne University	Pittsburgh, Pennsylvania	United States

+Investigators

Paula A Witt-Enderby, PhD, Principal investigator, Duquesne University