Identifying Mechanisms Underpinning the Impact of Daily Yogurt Supplementation on the Gut Microbiome, Inflammation and Bone Biomarkers in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Concentration of Bone Resorption Marker in Serum
研究概览
简要总结
Caribbean Latino adults are a vulnerable population at risk for developing osteoporosis. In addition to lifestyle factors, such as dietary intake, the investigators hypothesize that a unhealthy gut microbial environment coupled with high inflammation contributes to the risk of developing osteoporosis. There has been little research conducted on mechanisms underpinning how a low-intensity dietary intervention, including supplementation with daily yogurt, can affect the gut health of Caribbean Latino adults. The study objectives are to: 1) determine whether daily yogurt supplementation reduces bone turnover (biomarkers of overall bone health) and inflammation compared to a control group that maintains their usual diet (void of yogurt); and 2) collect preliminary data on the effects of daily yogurt supplementation on the gut microbiome compared to diet control group.
详细描述
Recruitment:
A total of 40 Caribbean Latino men and women ≥50 y will be recruited and enrolled from Greater Lawrence, MA, USA. Subjects will be recruited using flyers distributed throughout the communities including Senior Centers and other community organizations and agencies. The study team will also set up tables/booths at local festivals and community events. Interested participants will be directed to call a study-center call line to learn more about the study and to be screened for inclusion, if interested. For those who are eligible, the study team member will schedule the first interview, which will include obtaining consent.
Intervention Protocol:
40 study participants will undergo 12 study visits at the Lawrence Senior Center. They will first undergo a 4-week wash in baseline period. Participants will then undergo a two-month intervention (yogurt supplementation or control [maintenance of usual diet]). The study period will include weekly interviews (12 visits in total).
Baseline Month First interview (visit -3) in week 1 of the baseline month participants will be provided written informed consent. A trained bilingual interviewer will describe the study and answer any questions participants may have. The interviewer will also be available to read the consent form to participants in the event that he/she is unable to read. The consent forms will be stored in a locked file cabinet inside of a locked office at UMass Lowell.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •self-reported Caribbean Latino descent
- •at least 50 years of age
排除标准
- •usual yogurt intake (> 2 servings per week)
- •use of antibiotics in the past 6 months
- •regular weekly laxative use
- •self-reported osteoporosis
- •history of osteoporosis-related fracture
- •self-reported diagnosis of cancer
- •self-reported diagnosis of gastrointestinal diseases (Crohn's disease, ulcerative colitis, Clostridium difficile infection)
- •history of gastrointestinal alteration procedures (appendectomy, gastric bypass surgery)
- •use of osteoporosis drugs
- •use of steroids
- •use of chemotherapeutic agents
结局指标
主要结局
Concentration of Bone Resorption Marker in Serum
时间窗: 8 weeks
To evaluate bone health at baseline and at study completion, bone resorption marker, tartrate-resistant acid phosphatase subunit 5b (TRAP5b) in units/L will be measured in serum using ELISA kits.
Concentration of Bone Formation Markers in Serum
时间窗: 8 weeks
To evaluate bone health at baseline and at study completion, bone formation markers, pro-collagen I alpha 1 (P1NP) pg/mL and osteocalcin (OC) pg/mL will be measured in serum using ELISA kits.
次要结局
- Concentration of Fecal Short-Chain Fatty Acids(12 weeks)
- Concentration of Intestinal Integrity Biomarkers in Plasma(8 weeks)
- Concentration of C-Reactive Protein as a Marker of Systemic Inflammation in Serum(8 weeks)
- Aggregate Inflammatory Cytokine Score (ICS)(8 weeks)
- Profiling of the Gut Microbiota via Feces(12 weeks)
研究者
Kelsey Mangano
Associate Professor
University of Massachusetts, Lowell