Prunes for Bone Health
Recruiting in Palo Alto (17 mi)
Age: Any Age
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: San Diego State University
Must not be taking: Glucocorticoids, Neuroactive drugs
Disqualifiers: Smoking, BMD below 2.5 SD, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
Will I have to stop taking my current medications?
The trial requires that you stop taking any drugs known to affect bone and calcium metabolism, such as certain endocrine or neuroactive drugs, before participating.
What data supports the effectiveness of the treatment Prunes, Dried Plums for bone health?
Research shows that eating prunes (dried plums) can help improve bone health by increasing bone mineral density and reducing bone loss, especially in postmenopausal women. Studies have found that prunes have anti-inflammatory and antioxidant effects, which may contribute to their ability to protect and strengthen bones.12345
Is it safe for humans to consume prunes for bone health?
How do prunes differ from other treatments for bone health?
Prunes (dried plums) are unique because they are a natural, non-pharmaceutical option that can both prevent and reverse bone loss, unlike many treatments that only prevent further deterioration. They contain phenolics that enhance bone formation and inhibit bone resorption, and they also have anti-inflammatory and antioxidant effects, which are not typical features of standard bone health treatments.12689
Eligibility Criteria
This trial is for postmenopausal women who have a bone mineral density (BMD) t-score between -0.5 and -2, indicating some loss of bone density but not severe osteoporosis. Participants should not be on hormone replacement therapy or other drugs affecting bone health for at least three months before the study starts.Inclusion Criteria
I am postmenopausal.
BMD t-score is between 0.5 and 2 SD below the mean
I haven't taken hormone therapy or bone-affecting drugs in the last 3 months.
Exclusion Criteria
Subjects who smoke cigarettes or vape
Regular consumption of dried plum or prune juice
Women whose BMD t-score at any site falls below 2.5 SD of the mean
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive 500 mg calcium and 400 IU vitamin D daily, with one group also receiving 30 g of prunes daily for 24 months
24 months
Visits at baseline, 12 months, and 24 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- Prunes (Other)
Trial OverviewThe study is testing whether prunes, in combination with calcium and vitamin D supplements, can help prevent further bone loss in postmenopausal women compared to just taking the supplements alone.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: 30 g prune/dayExperimental Treatment1 Intervention
Participants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.
Group II: Control (0 g prune/day)Active Control1 Intervention
Participants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.
Prunes is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Prunes/Dried Plums for:
- General health supplement
- Supports bone health
🇪🇺 Approved in European Union as Prunes/Dried Plums for:
- General health supplement
- Supports bone health
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
San Diego State UniversitySan Diego, CA
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Who Is Running the Clinical Trial?
San Diego State UniversityLead Sponsor
References
The Role of Prunes in Modulating Inflammatory Pathways to Improve Bone Health in Postmenopausal Women. [2023]The prevalence of osteoporosis among women aged 50 y and older is expected to reach 13.6 million by 2030. Alternative nonpharmaceutical agents for osteoporosis, including nutritional interventions, are becoming increasingly popular. Prunes (dried plums; Prunus domestica L.) have been studied as a potential whole-food dietary intervention to mitigate bone loss in preclinical models of osteoporosis and in osteopenic postmenopausal women. Sixteen preclinical studies using in vivo rodent models of osteopenia or osteoporosis have established that dietary supplementation with prunes confers osteoprotective effects both by preventing and reversing bone loss. Increasing evidence from 10 studies suggests that, in addition to antiresorptive effects, prunes exert anti-inflammatory and antioxidant effects. Ten preclinical studies have found that prunes and/or their polyphenol extracts decrease malondialdehyde and NO secretion, increase antioxidant enzyme expression, or suppress NF-κB activation and proinflammatory cytokine production. Two clinical trials have investigated the impact of dried plum consumption (50-100 g/d for 6-12 mo) on bone health in postmenopausal women and demonstrated promising effects on bone mineral density and bone biomarkers. However, less is known about the impact of prune consumption on oxidative stress and inflammatory mediators in humans and their possible role in modulating bone outcomes. In this review, the current state of knowledge on the relation between inflammation and bone health is outlined. Findings from preclinical and clinical studies that have assessed the effect of prunes on oxidative stress, inflammatory mediators, and bone outcomes are summarized, and evidence supporting a potential role of prunes in modulating inflammatory and immune pathways is highlighted. Key future directions to bridge the knowledge gap in the field are proposed.
Viewpoint: dried plum, an emerging functional food that may effectively improve bone health. [2019]Osteoporosis is a debilitating disorder that affects both female and male, albeit to a greater extent in women than men. As the demographic shift to a more aged population continues, a growing number of men and women will be afflicted with osteoporosis and a search for potential non-pharmacological alternative therapies for osteoporosis is of prime interest. Aside from existing drug therapies, certain lifestyle and nutritional factors are known to reduce the risk of osteoporosis. Among nutritional factors, recent observations suggest that dried plum, or prunes (Prunus domestica L.) is the most effective fruit in both preventing and reversing bone loss. Animal studies and a 3-month clinical trial conducted in our laboratories have shown that dried plum has positive effects on bone indices. The animal data indicate that dried plum not only protects against but more importantly reverses bone loss in two separate models of osteopenia. Our initial animal study indicated that dried plum prevented the ovariectomy-induced reduction in bone mineral density (BMD) of the femur and lumbar vertebra. In another study, to mimic established osteoporosis, rats were ovariectomized and allowed to lose bone before the initiation of treatment. Dried plum as low as 5% (w/w) restored BMD to the level of intact rats. More importantly, dried plum reversed the loss of trabecular architectural properties such as trabecular number and connectivity density, and trabecular separation. We have also shown the effectiveness of dried plum in reversal of bone loss due to skeletal unloading. Analysis of BMD and trabecular bone structure by microcomputed tomography (microCT) revealed that dried plum enhanced bone recovery during reambulation following skeletal unloading and had comparable effects to parathyroid hormone. In addition to the animal studies, our 3-month clinical trial indicated that the consumption of dried plum daily by postmenopausal women significantly increased serum markers of bone formation, total alkaline phosphatase, bone-specific alkaline phosphatase and insulin-like growth factor-I by 12, 6, and 17%, respectively. This review summarizes the findings of studies published to date which examine the beneficial effects of dried plum on bone in both female and male animal models of osteoporosis as well as the only published clinical study.
The Short-Term Effect of Prunes in Improving Bone in Men. [2022]Osteoporosis is a major health concern in aging populations, where 54% of the U.S. population aged 50 and older have low bone mineral density (BMD). Increases in inflammation and oxidative stress play a major role in the development of osteoporosis. Men are at a greater risk of mortality due to osteoporosis-related fractures. Our earlier findings in rodent male and female models of osteoporosis, as well as postmenopausal women strongly suggest the efficacy of prunes (dried plum) in reducing inflammation and preventing/reversing bone loss. The objective of this study was to examine the effects of two doses of prunes, daily, on biomarkers of inflammation and bone metabolism in men with some degree of bone loss (BMD; t-score between -0.1 and -2.5 SD), for three months. Thirty-five men between the ages of 55 and 80 years were randomized into one of three groups: 100 g prunes, 50 g prunes, or control. Consumption of 100 g prunes led to a significant decrease in serum osteocalcin (p < 0.001). Consumption of 50 g prunes led to significant decreases in serum osteoprotegerin (OPG) (p = 0.003) and serum osteocalcin (p = 0.040), and an increase in the OPG:RANKL ratio (p = 0.041). Regular consumption of either 100 g or 50 g prunes for three months may positively affect bone turnover.
Comparative effects of dried plum and dried apple on bone in postmenopausal women. [2016]Aside from existing drug therapies, certain lifestyle and nutritional factors are known to reduce the risk of osteoporosis. Among the nutritional factors, dried plum or prunes (Prunus domestica L.) is the most effective fruit in both preventing and reversing bone loss. The objective of the present study was to examine the extent to which dried plum reverses bone loss in osteopenic postmenopausal women. We recruited 236 women, 1-10 years postmenopausal, not on hormone replacement therapy or any other prescribed medication known to influence bone metabolism. Qualified participants (n 160) were randomly assigned to one of the two treatment groups: dried plum (100 g/d) or dried apple (comparative control). Participants received 500 mg Ca plus 400 IU (10 μg) vitamin D daily. Bone mineral density (BMD) of lumbar spine, forearm, hip and whole body was assessed at baseline and at the end of the study using dual-energy X-ray absorptiometry. Blood samples were collected at baseline, 3, 6 and 12 months to assess bone biomarkers. Physical activity recall and 1-week FFQ were obtained at baseline, 3, 6 and 12 months to examine physical activity and dietary confounders as potential covariates. Dried plum significantly increased BMD of ulna and spine in comparison with dried apple. In comparison with corresponding baseline values, only dried plum significantly decreased serum levels of bone turnover markers including bone-specific alkaline phosphatase and tartrate-resistant acid phosphatase-5b. The findings of the present study confirmed the ability of dried plum in improving BMD in postmenopausal women in part due to suppressing the rate of bone turnover.
Effects of Short-Term Dried Plum (Prune) Intake on Markers of Bone Resorption and Vascular Function in Healthy Postmenopausal Women: A Randomized Crossover Trial. [2020]Osteoporosis and cardiovascular disease are global health burdens, with postmenopausal women being at great risk. Dried plums/prunes (DPs) have been reported to provide bone health benefits in animal models, which is consistent with in vitro models. Data from human studies suggest that DP intake can enhance lipid metabolism, anti-inflammatory, and oxidant defense systems, which can impact cardiovascular health. We tested the hypothesis that short-term consumption of low and reasonable levels of DPs augments bone resorption and vascular function. Twenty-seven healthy, postmenopausal women were randomly assigned to consume six DPs (∼42 g) or two DPs (∼14 g) per day for 2 weeks, then a 2-week washout period and then crossed over. Serum C-telopeptide, beta-crosslinked (CTX) was used as a measure of bone resorption. Peripheral artery tonometry (PAT) was used to assess microvascular function. The pattern of changes in CTX in the second 2-week period (no change or decline) differed significantly from the pattern in the first 2 weeks (increases in both groups; F = 9.26, P = .006), suggesting a trend in CTX reduction (i.e., a decrease in bone resorption) in those consuming six DPs per day in the second phase. No effects on vascular function were noted. A significant interaction was observed for the augmentation index, a measure of arterial stiffness, between treatment and years after menopause (P = .045). The results suggest a potentially favorable impact of DPs on bone health when assessed with a short-term, crossover study design in postmenopausal women. Given the novel assessments used in this study, follow-up studies are warranted.
Dried Plums, Prunes and Bone Health: A Comprehensive Review. [2018]The 2015-2020 Dietary Guidelines for Americans advocate for increasing fruit intake and replacing energy-dense foods with those that are nutrient-dense. Nutrition across the lifespan is pivotal for the healthy development and maintenance of bone. The National Osteoporosis Foundation estimates that over half of Americans age 50+ have either osteoporosis or low bone mass. Dried plums, also commonly referred to as prunes, have a unique nutrient and dietary bioactive profile and are suggested to exert beneficial effects on bone. To further elucidate and summarize the potential mechanisms and effects of dried plums on bone health, a comprehensive review of the scientific literature was conducted. The PubMed database was searched through 24 January 2017 for all cell, animal, population and clinical studies that examined the effects of dried plums and/or extracts of the former on markers of bone health. Twenty-four studies were included in the review and summarized in table form. The beneficial effects of dried plums on bone health may be in part due to the variety of phenolics present in the fruit. Animal and cell studies suggest that dried plums and/or their extracts enhance bone formation and inhibit bone resorption through their actions on cell signaling pathways that influence osteoblast and osteoclast differentiation. These studies are consistent with clinical studies that show that dried plums may exert beneficial effects on bone mineral density (BMD). Long-term prospective cohort studies using fractures and BMD as primary endpoints are needed to confirm the effects of smaller clinical, animal and mechanistic studies. Clinical and prospective cohort studies in men are also needed, since they represent roughly 29% of fractures, and likewise, diverse race and ethnic groups. No adverse effects were noted among any of the studies included in this comprehensive review. While the data are not completely consistent, this review suggests that postmenopausal women may safely consume dried plums as part of their fruit intake recommendations given their potential to have protective effects on bone loss.
Rationale and study design of Randomized Controlled Trial of Dietary Supplementation with prune (dried plums) on bone density, geometry, and estimated bone strength in postmenopausal women: The Prune study. [2022]The use of non-pharmacological alternatives to pharmacological interventions, e.g., nutritional therapy, to improve or maintain bone mineral density (BMD) in postmenopausal women has gained traction over the past decade, but limited data exist regarding its efficacy. This paper describes the design of the Prune Study, a randomized controlled trial (RCT) that explored the effectiveness of a 12-month intervention of daily prune consumption on bone density, bone structure and strength estimates, bone turnover, various biomarkers of immune function, inflammation, and cardiovascular health, as well as phenolic and gut microbiota analyses. Postmenopausal women between the ages of 55-75 years were randomized into either control group (no prune consumption; n = 78), 50g prune (50g prune/day; n = 79), or 100g prune (100g prune/day; n = 78). All participants received 1200 mg calcium +800 IU vitamin D3 daily as standard of care. The Prune Study is the largest and most comprehensive investigation of a dose response of prune consumption on bone health, biomarkers of immune function, inflammation, and cardiovascular health, as well as detailed phenolic and gut microbiota analyses in postmenopausal women. 235 women were randomized and 183 women completed the entire study. The findings of this study will help expand our current understanding of clinical implications and mechanisms underlying the resultant health effects of prune as a functional food therapy.
The effect of two doses of dried plum on bone density and bone biomarkers in osteopenic postmenopausal women: a randomized, controlled trial. [2018]Daily consumption of 50 g of dried plum (equivalent to 5-6 dried plums) for 6 months may be as effective as 100 g of dried plum in preventing bone loss in older, osteopenic postmenopausal women. To some extent, these results may be attributed to the inhibition of bone resorption with the concurrent maintenance of bone formation.
Dried Plum Polyphenolic Extract Combined with Vitamin K and Potassium Restores Trabecular and Cortical Bone in Osteopenic Model of Postmenopausal Bone Loss. [2020]Dried plum has unique anabolic effects on bone, but the responsible bioactive components have remained unclear. This study investigated components of dried plum with potential osteoprotective activity utilizing aged, osteopenic Sprague Dawley rats fed diets supplemented with a crude polyphenol extract, potassium, vitamin K or their combination. Whole body and femoral bone mineral density were restored with the polyphenol and combination treatments to a similar extent as the dried fruit. The combination treatment reversed trabecular bone loss in the spine and cortical bone in the femur mid-diaphysis in a similar manner. Biomarkers of bone resorption were reduced by the polyphenol and combination treatments. The polyphenol extract accounted for most of the anabolic effect of dried plum on bone. This study is the first to show the bioactive components in dried plum responsible for restoring bone in vivo.