RECRUITINGINTERVENTIONAL

Prunes Preventing Bone Loss in Perimenopause

A Prevention Strategy for the Indication of Prune Consumption in Perimenopausal Females: Can Prunes Attenuate Bone Loss?

About This Trial

Dietary interventions of prune consumption during the transmenopausal period are innovative methods to prevent bone loss. Modern medicine does not intervene to prevent or attenuate this highly vulnerable period of bone loss which, if successfully attenuated, can potentially prevent/delay osteoporosis in women. The transmenopausal period represents an opportunistic window for the study because bone loss is at its greatest at this time, with females losing as much as 6-7% of bone. If this project is successful at attenuating bone loss, it can immediately be disseminated to the public to promote prune consumption to slow down and attenuate perimenopausal bone loss. As such, this project could improve the long-term bone health of females and avoid or delay osteoporosis and improve quality of life. The long-term goal of this study is to test the novel hypothesis that prune consumption for 18 months during the 3-year transmenopausal period prevents the dramatic rate of bone loss in perimenopausal females during a window of heightened physiological vulnerability. At Penn State University, the study will compare the effects of 18 months of daily dietary consumption of 50 g of prunes (5-6) versus a no-prune control group on bone outcomes (bone mineral density, bone geometry), mechanistic factors (bone and inflammatory markers, inflammatory response of ex vivo cultured peripheral blood mononuclear cells, monocytes), and gut microbiome.

Who May Be Eligible (Plain English)

Who May Qualify: - Age 44 to 55 years - Not severely obese (BMI \<35 kg/m\^2) - Healthy (determined by a screening questionnaire, physical and medical history by a certified nurse practitioner, complete metabolic panel, and complete blood count) - Willing to include prunes in their daily diet - Not taking any natural dietary supplement containing phenolics, i.e.,\< 1 cup/day of blueberries or apples for at least 2 months prior to study entry - Non-smoking - Ambulatory - No menses for ≥60 days but not more than 18 months post final menstrual period - Only participants who have a determinable natural (not surgical) final menstrual period date are eligible Who Should NOT Join This Trial: - Subjects who regularly consume prunes, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day) - History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 45 yr) - Untreated hyper- or hypothyroidism - Current hyper- or hypoparathyroidism - Significantly impaired renal function - Current hypo- or hypercalcemia - History of spinal stenosis - History of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, or 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; 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 - Hormonal contraception within the past three months - Subjects who will not consume study provided dietary items or who will not stop taking their own natural product supplements Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Age 44 to 55 years * Not severely obese (BMI \<35 kg/m\^2) * Healthy (determined by a screening questionnaire, physical and medical history by a certified nurse practitioner, complete metabolic panel, and complete blood count) * Willing to include prunes in their daily diet * Not taking any natural dietary supplement containing phenolics, i.e.,\< 1 cup/day of blueberries or apples for at least 2 months prior to study entry * Non-smoking * Ambulatory * No menses for ≥60 days but not more than 18 months post final menstrual period * Only participants who have a determinable natural (not surgical) final menstrual period date are eligible Exclusion Criteria: * Subjects who regularly consume prunes, dried apples, prune juice, or heavy consumers of blueberries (1 cup or more/day) * History of vertebral fracture or fragility fracture of the wrist, humerus, hip or pelvis after age 45 yr) * Untreated hyper- or hypothyroidism * Current hyper- or hypoparathyroidism * Significantly impaired renal function * Current hypo- or hypercalcemia * History of spinal stenosis * History of heart attack, stroke, thromboembolism, kidney disease, malabsorption syndrome, or 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; 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 * Hormonal contraception within the past three months * Subjects who will not consume study provided dietary items or who will not stop taking their own natural product supplements

Treatments Being Tested

DIETARY_SUPPLEMENT

Prunes

Participants randomized to the 50g prune group will consume 6 prunes per day for the duration of the 18-month intervention.

DIETARY_SUPPLEMENT

Calcium supplement

All participants will consume calcium supplements daily for a baseline period and for the duration of the 18-month intervention.

DIETARY_SUPPLEMENT

Vitamin D Supplement

All participants will consume Vitamin D supplements daily for a baseline period and for the duration of the 18-month intervention.

Locations (1)

Women's Health and Exercise Laboratory, The Pennsylvania State University

University Park, Pennsylvania, United States