Herbal Teas on Bone Health in an Osteopenic Population

Not Applicable

Completed

• Conditions: Osteopenia
• Interventions: Other: Herbal Teas

• Registration Number: NCT03480126
• Lead Sponsor: Paula Witt-Enderby

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-20
• Study First Posted: 2018-03-29
• Study Start: 2018-06-01
• Primary Completion: 2019-08-27
• Study Completion: 2019-08-27
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-22
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Herbal Tea 3	Herbal Teas	Experimental Herbal Tea B will be ingested 3 times per day for 3 months
Herbal Tea 4	Herbal Teas	Experimental Herbal Tea C will be ingested 3 times per day for 3 months
Herbal Tea 1	Herbal Teas	Placebo Tea should will be ingested 3 times per day for 3 months
Herbal Tea 2	Herbal Teas	Experimental Herbal Tea A will be ingested 3 times per day for 3 months

Primary Outcome Measures

Name	Time	Method
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 the Ratio of CTx:P1NP	3 months	Urinary CTx:P1NP 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

Trial Locations

Locations (1)

Duquesne University; 🇺🇸 Pittsburgh, Pennsylvania, United States