A Pilot Plant-Based Dietary Intervention in Overweight and Obese Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION) Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 23
- 试验地点
- 14
- 主要终点
- Difference of Body Mass Index From Baseline to Week 12
研究概览
简要总结
This study will test whether a plant-based diet is practical (feasible) for overweight people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The researchers will decide how practical the diet is by looking at how much weight participants lose and how well they are able to stick to the diet. The researchers will also determine whether the diet is effective in preventing multiple myeloma in participants. In addition, they will look at how safe the plant-based diet is for participants, and see if the diet affects participants' quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of MGUS or SMM
- •M spike (immunoglobulin) ≥0.2 g/dL or abnormal free light chain ratio with increased level of the appropriate involved light chain
- •Secretory disease
- •Age ≥18 years
- •Willingness to comply with all study-related procedures
- •ECOG performance status of 0-3
- •Interest to learn to cook plant based recipes
排除标准
- •Patients that already follow a whole foods plant based or vegan diet (ovo-lactovegetarian diets are not excluded)
- •Legume allergy
- •Severe allergies, such as anaphylactic shock to peanuts
- •Concurrent participation in weight loss/dietary/exercise programs
- •Mental impairment leading to inability to cooperate
- •Enrollment onto any other therapeutic investigational study
- •Concurrent pregnancy
- •Patients with a known diagnosis of diabetes mellitus will not be excluded but will need to be followed regularly with an endocrinologist/primary care physician during the trial period.
- •Positive HBV, HCV, HIV PCR testing
- •Non English speaking
- •≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
- •If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely
结局指标
主要结局
Difference of Body Mass Index From Baseline to Week 12
时间窗: 12 weeks
Weight loss is defined as the average decrease in BMI at 12 weeks
Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks
时间窗: 12 weeks
Intervention defined as ≥70% of participants consuming a whole food, plant-based diet/WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey).
次要结局
未报告次要终点