OsTea Study – Adults with Osteopenia

STUDY BASICS

Have you been diagnosed with osteopenia (early stage of osteoporosis), and are you concerned about thinning bones? If so, you may be eligible to participate in a research study to help find out if drinking herbal teas can improve bone health and quality of life. Eligible participants are non-smokers, have already undergone a DXA scan, and are willing to drink tea for 3 months.

STUDY PURPOSE

People with osteopenia have bones that are weaker than normal. Over time, osteopenia often develops into osteoporosis—a disease in which the bones are thin and brittle, and break easily. Current treatments to prevent osteopenia from developing into osteoporosis include medications, dietary supplements, and lifestyle changes, but these interventions are not always effective and medications can have significant side effects. The purpose of this study is to help researchers find out if drinking herbal teas can improve bone health and quality of life in people who have been diagnosed with osteopenia. Some research has shown that certain herbal teas contain substances that may help protect against bone loss and osteoporosis. Researchers hope their findings will lead to better bone health in the future.

COULD THIS STUDY BE RIGHT FOR YOU?

• Males and females ages 18 and up
• Non-smokers
• Diagnosed by a doctor with osteopenia and/or show evidence of thinning bones on a DXA scan (bone density T-score -1 to -2.5). (If unsure, research staff can review your DXA scan results.)
• Osteopenia is not caused by hyperparathyroidism, multiple myeloma, metastatic bone disease, or chronic steroid use
• Not diagnosed with osteoporosis
• Not taking any medications for bone disease
• Willing to drink tea for 3 months
• Female participants must not be diagnosed with COPD (chronic obstructive pulmonary disease)

WHAT PARTICIPANTS CAN EXPECT

Participation involves 4 in-person visits over 3 months. At home/work, all participants will be asked to drink 3 cups of tea (hot or iced) 3 times per day for 3 months. Tea will be provided by the study team at no cost. It is important to know that participants will be randomly assigned (like rolling dice) to one of four study groups. Three groups will receive herbal tea that has been shown to improve bone health and one group will receive placebo tea that is not known to improve bone health. Participants will also be asked to keep track of your exercise, tea intake, sleep, and other information in a daily diary. During the 4 in-person visits, participants will hand in diary sheets, fill out questionnaires, have your blood pressure measured, and receive tea supply. During the first and last visits only, participants will provide urine and saliva samples and will receive an at-home stool sample kit.