Herbal Teas on Bone Health in an Osteopenic Population (OsTea)

Paula Witt-Enderby

Status: Completed

Conditions: Osteopenia

Treatments: Other: Herbal Teas

Study type: Interventional

Funder types: Other

Identifiers

NCT03480126

2018/02/7

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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35 participants in 4 patient groups, including a placebo group

Herbal Tea 1

Placebo Comparator group

Description:

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

Treatment:

Other: Herbal Teas

Herbal Tea 2

Experimental group

Description:

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

Treatment:

Other: Herbal Teas

Herbal Tea 3

Experimental group

Description:

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

Treatment:

Other: Herbal Teas

Herbal Tea 4

Experimental group

Description:

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

Treatment:

Other: Herbal Teas