A Randomized, Double-Blind, Placebo-Controlled, Clinical Food Trial of Probiotic/Prebiotic Medical Food for the Dietary Management of Age Related Bone Loss
概览
- 阶段
- 不适用
- 干预措施
- SBD111 medical food
- 疾病 / 适应症
- Osteoporosis
- 发起方
- Hebrew SeniorLife
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Lumbar spine BMD (g/cm2)
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
This randomized, double blind, placebo controlled clinical trial will test the efficacy of a probiotic/prebiotic combination ("synbiotic") on the skeleton in older women.
详细描述
There are currently no consistent guidelines on how middle aged and older adults can maintain healthy bone mass as they age. Hence, there is an unmet need for safe and effective dietary interventions for the metabolic processes underlying bone loss. The objective of this project, is to test the efficacy of a probiotic/prebiotic combination or synbiotic i.e. Solarea Bio defined microbial assemblage 111 (SBD111) medical food on the skeleton of older women. Aim 1: To determine the effect of 18 months of daily intake of SBD111 medical food on the primary outcome of lumbar spine dual energy x-ray absorptiometry (DXA) bone mineral density (BMD) and secondary outcomes (Biomechanical Computed Tomography analysis (BCT)-derived vertebral compressive strength, volumetric BMD (vBMD), and markers of bone turnover) in women. Hypothesis 1a: BMD, vertebral compressive strength, and vBMD will be greater in women randomized to SBD111 medical food compared to placebo. Hypothesis 1b: Biochemical markers of bone turnover will decrease with SBD111 medical food use compared to placebo. Aim 2: To determine the effect of 18 months of daily intake of SBD111 medical food on markers of inflammation and gut microbiome function (secondary outcomes) in women. Hypothesis 2a: Markers of inflammation \[interleukin 17A (IL17A) and tumor necrosis factor alpha (TNF-α)\] will be reduced with SBD111 medical food use compared to placebo. Hypothesis 2b: Functional genes and pathways related to fiber breakdown (glycosyl hydrolases), menaquinone 7 production, and short chain fatty acid (SCFA) production, will be enriched in stool metagenomes and upregulated in stool metatranscriptomes from those receiving SBD111 medical food compared to placebo. Eligible women will be randomized to SBD111 medical food versus placebo capsules for 18 months. Assessments will be made at the in-person baseline visit, 9-month and 18-month follow-up visits as well as monthly telephone calls. The primary outcome is lumbar spine BMD (g/cm2) and secondary outcomes include vertebral compressive strength (N), vBMD (g/cm3), and bone biomarkers. Intent-to-treat analysis will be conducted for all endpoints.
研究者
入排标准
入选标准
- •1\. Provided written informed consent.
- •2\. Stated availability throughout entire study period and willingness to fulfill all details of the protocol.
- •3\. Age 60 years and above.
- •4\. DXA-BMD of the hip and spine (T-score) \> -2.
- •Women with a BMD T score ≤ -2.5 (i.e. women with low BMD indicating osteoporosis) will also be considered if they have decided not to accept the standard of care use of osteoporosis medications for the entire duration of their participation in the study.
- •5\. Women with a history of major low-trauma fragility fractures (hip, forearm, humerus, spine) since the age of 50 years will be considered if they are not currently using osteoporosis medications, or if they have decided not to accept the standard of care osteoporosis medications, even if diagnosed with osteoporosis during the screening procedure.
- •6\. Serum 25-hydroxyvitamin D ≥ 20 ng/mL.
- •7\. Normal renal function (eGFR \>50 ml/min).
- •8\. Have chosen to not accept the standard of care use of osteoporosis medications for the duration of the study.
- •9\. Willing to comply with protocol and report on compliance and side effects during the study period.
排除标准
- •1\. BMI greater than 40 kg/m
- •2\. Participants consuming dietary supplements (fish oil, probiotics/prebiotics, and fiber) in the prior month, and unwilling to avoid these supplements for the duration of the study.
- •3\. Participants using osmotic laxatives \>1 per week and unwilling to avoid use for the duration of the study.
- •4\. Known or suspected allergies to probiotics, rice, edible fruit extract or berries.
- •5\. Antibiotic use in the past 3 months. Participants placed on an antibiotic after enrollment will be retained.
- •6\. History of drug and/or alcohol abuse at the time of enrolment.
- •7\. Presence of any of the following:
- •a. History of other bone disorders (e.g. Paget's disease).
- •b. History of moderate to severe scoliosis.
- •c. History of cancer other than skin cancer \<5 years in remission, autoimmune disease, immune problems such as AIDS, type 1 or 2 diabetes.
研究组 & 干预措施
SBD111 medical food
This group will receive SBD111 medical food capsules to be consumed over 18 months.
干预措施: SBD111 medical food
Placebo
This group will receive placebo capsules to be consumed over 18 months.
干预措施: Placebo
结局指标
主要结局
Lumbar spine BMD (g/cm2)
时间窗: Change over 18 months
BMD of the lumbar spine (L1-L4) will be measured at the baseline exam, 9-month, and 18-month final follow-up visit
次要结局
- Vertebral compressive strength (N)(Change over 18 months)
- volumetric BMD(Change over 18 months)
- Procollagen Type I Intact N-terminal Propeptide (P1NP)(Change over 18 months)
- C-terminal cross-linked telopeptide of type I collagen (β-CTX)(Change over 18 months)