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OpenTrials
Completed

NCT Number: NCT03480126

Herbal Teas on Bone Health in an Osteopenic Population

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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Key information

Conditions

Osteopenia Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Herbal Teas

Other

Steeped tea ingested 3 times a day for 3 mos

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 3 months

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

Sponsors and collaborators

Lead sponsor

Paula Witt-Enderby

Other

Collaborators

  • Duquesne University

Registry information

Official study title

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

Acronym: OsTea

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 29, 2018
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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