Herbal Teas on Bone Health in an Osteopenic Population

Study Overview
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Brief Summary
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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.

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

Conditions
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Osteopenia

Intervention / Treatment
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* Other: Herbal Teas


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |