UnknownPhase 1/2

Effect of Blueberries on Bone Turnover

United States20 participantsStarted 2017-01-12

Plain-language summary

This study uses a bone labeling calcium tracer methodology to compare the dose-response effect of blueberry consumption on calcium retention and bone loss. Post-menopausal women will receive food or beverage products containing freeze-dried blueberries in the amount equivalent to 0.75 (low), 1.5 (medium), and 3 cups (high) of fresh blueberries per day over a 42-day period. The hypothesis is that the polyphenolics found in blueberries will reduce calcium loss from bones.

Who can participate

Age range45 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female subject is healthy * Subject is \> 4 years past the onset of natural menopause or total hysterectomy Exclusion Criteria: * History of metabolic bone disease or low trauma fractures; * Subject taking osteoporosis treatment drugs or glucocorticoids within 6 months of the beginning of the study; * Subjects taking bisphosphonates within 2 years of the beginning of the study; * History of cancer, thromboembolisms, clotting disorders, uncontrolled hypertension, abnormal thyroid function, malabsorption syndrome, seizure disorders, or heart attack; * BMI \> 35 kg/m2; * Subjects who will not comply with study interventions ; * Subjects who will not stop taking natural product supplements of their own selection.

What they're measuring

Ca-41 / Ca ratio in 24-hour urinary excretion to estimate calcium loss from bone

Timeframe: From the beginning of baseline (week 0) to the end of the 3rd washout period (week 42)

Trial details

NCT IDNCT02630797

SponsorPurdue University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-01

View on ClinicalTrials.gov More Osteoporosis, Postmenopausal trials