Dried Plums and Bone Health in Postmenopausal Women
Postmenopausal Osteoporosis
About this trial
This is an interventional prevention trial for Postmenopausal Osteoporosis focused on measuring Postmenopausal Osteoporosis, Human, Female, Non-pharmacologic therapy
Eligibility Criteria
Inclusion Criteria:
- Postmenopausal women
- not severely obese (BMI < 40 kg/m2);
- healthy (determined by a screening questionnaire, complete metabolic panel);
- willing to include dried plums in their daily diet;
- not taking any natural dietary supplement containing phenolics, blueberries or apples for at least 2 months prior to study entry; can stop for 2 months to meet entry criteria
- non-smoking; ambulatory;
- low BMD as measured by dual energy X-ray absorptiometry (DXA). Eligible BMD values (T-scores) for DXA measures of the lumbar spine, total hip and/or femoral neck will correspond to T-scores between 0 and -3.0.
Exclusion Criteria:
- Women who regularly consume dried plums, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day). Potential volunteers who will refrain from consumption of the afore mentioned foods for the duration of the study will become eligible after a 2 month washout period;
- vitamin D deficiency (<20 ng/mL);
- history of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 50 yr);
- untreated hyper- or hypothyroidism;
- current hyper- or hypoparathyroidism;
- significantly impaired renal function; high potassium
- current hypo- or hypercalcemia;
- history of spinal stenosis;
- history of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, seizure disorders;
- positive for HIV, Hep-C or Hep-B surface antigen and malignancy.
Use of the following agents affecting bone metabolism:
- intravenous bisphosphonates at any time;
- fluoride (for osteoporosis) within the past 24 months;
- denosumab at any time;
- bisphosphonates, parathyroid hormone or strontium within the past 12 months;
- calcitonin or selective estrogen receptor modulators within the past 12 months;
- systemic oral or transdermal estrogen within the past 3 months;
- systemic glucocorticosteroids (≥ 5 mg prednisone equivalent per day for more than 10 days); or
- tibolone within the past 3 months.
- Participants who will not consume study therapy or will not stop taking natural product supplements of their own selection.
Sites / Locations
- Women's Health and Exercise Laboratories, The Pennsylvania State University
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Ca2+/VitD Control
50g Dried Plums
100g Dried Plums
Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Participants will be asked to refrain from consumption of dried plums for the duration of the intervention (52 weeks).
Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 6 (50g) dried plums per day for the duration of the intervention (52 weeks).
Participants will take calcium and vitamin D supplements for the duration of the baseline and intervention. Additionally, participants will be provided with dried plums and asked to consume 12 (100g) dried plums per day for the duration of the intervention (52 weeks).