NCT03480126

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2019

Completed
Last Updated

January 11, 2022

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

February 28, 2018

Last Update Submit

December 22, 2021

Conditions

Osteopenia

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (4)

Herbal Tea 1

PLACEBO COMPARATOR

Placebo Tea should will be ingested 3 times per day for 3 months

Other: Herbal Teas

Herbal Tea 2

EXPERIMENTAL

Experimental Herbal Tea A will be ingested 3 times per day for 3 months

Other: Herbal Teas

Herbal Tea 3

EXPERIMENTAL

Experimental Herbal Tea B will be ingested 3 times per day for 3 months

Other: Herbal Teas

Herbal Tea 4

EXPERIMENTAL

Experimental Herbal Tea C will be ingested 3 times per day for 3 months

Other: Herbal Teas

Interventions

Herbal TeasOTHER

Steeped tea ingested 3 times a day for 3 mos

Herbal Tea 1Herbal Tea 2Herbal Tea 3Herbal Tea 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

Location

Related Links

MeSH Terms

Conditions

Bone Diseases, Metabolic

Interventions

Teas, Herbal

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Paula A Witt-Enderby, PhD

    Duquesne University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Pharmacology

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 29, 2018

Study Start

June 1, 2018

Primary Completion

August 27, 2019

Study Completion

August 27, 2019

Last Updated

January 11, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)