Effect of Blueberries on Bone Turnover
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Osteoporosis, Postmenopausal Syndrome |
| Therapuetic Areas: | Endocrinology, Rheumatology |
| Healthy: | No |
| Age Range: | 45 - 70 |
| Updated: | 5/9/2018 |
| Start Date: | January 12, 2017 |
| End Date: | August 2019 |
Berries and Bones: The Effect of Polyphenolic Metabolites From Blueberries on Bone Turnover
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.
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.
Participants will be dosed with Ca-41, a rare long-lived radioisotope of calcium. After the
equilibration of tracer in the body and its deposition in bones (150 days), subjects will be
randomized to one of 6 dose sequences, all of which will begin with a 42-day baseline period.
During baseline, 24-hour urine will be collected every 14 days. Following baseline, subjects
will enter a 42-day intervention period with one of three doses of blueberries equivalent to
0.75 (low), 1.5 (medium), and 3 cups (high) of blueberries per day. Each dose will be
provided in the form of freeze-dried blueberry powder incorporated in 2-4 foods or beverages
per day. During the intervention, 24-hour urine will be collected weekly for 6 weeks except
week 1. After intervention, subjects will enter a 42-day washout period, during which 24-hour
urine will be collected every 3 weeks. The entire study duration will be 444 days for
subjects who have not been dosed with Ca-41 previously. In a crossover design, all subjects
will complete three 42-day intervention periods corresponding to the three doses of
blueberries (low, medium, and high), each followed by a 42-day washout period. The
dose-response effect of continuous blueberry consumption over a 42-day period on bone
resorption in healthy post-menopausal women will be studied by measuring the loss of Ca-41 in
urine by Accelerator Mass Spectrometry.
equilibration of tracer in the body and its deposition in bones (150 days), subjects will be
randomized to one of 6 dose sequences, all of which will begin with a 42-day baseline period.
During baseline, 24-hour urine will be collected every 14 days. Following baseline, subjects
will enter a 42-day intervention period with one of three doses of blueberries equivalent to
0.75 (low), 1.5 (medium), and 3 cups (high) of blueberries per day. Each dose will be
provided in the form of freeze-dried blueberry powder incorporated in 2-4 foods or beverages
per day. During the intervention, 24-hour urine will be collected weekly for 6 weeks except
week 1. After intervention, subjects will enter a 42-day washout period, during which 24-hour
urine will be collected every 3 weeks. The entire study duration will be 444 days for
subjects who have not been dosed with Ca-41 previously. In a crossover design, all subjects
will complete three 42-day intervention periods corresponding to the three doses of
blueberries (low, medium, and high), each followed by a 42-day washout period. The
dose-response effect of continuous blueberry consumption over a 42-day period on bone
resorption in healthy post-menopausal women will be studied by measuring the loss of Ca-41 in
urine by Accelerator Mass Spectrometry.
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.
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