A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 16
- 主要终点
- Stool microbiome diversity at 12 weeks
研究概览
简要总结
The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.
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
- Double (Participant, Investigator)
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
- •If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
- •If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
- •If IgA MGUS/SMM then an IgA level >350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
- •If IgD MGUS/SMM then an IgD level >50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
- •Age ≥18 years
- •Willingness to comply with all study-related procedures
- •ECOG performance status of 0-3
- •Interested in learning to cook plant based recipes
排除标准
- •Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
- •Legume allergy
- •Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
- •Concurrent participation in weight loss/dietary/exercise programs
- •Mental impairment leading to inability to cooperate
- •Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
- •Concurrent pregnancy
- •Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
- •≥ 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 or any contraindications
- •Heavy drinker (defined as >2 drinks per day or >14 drinks per week)
- •Current self-reported illicit drug use (eg heroin, cocaine not marijuana)
- •Plan for prolonged travel during the study that would preclude adherence to prescribed diets
- •History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment
- •If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.
研究组 & 干预措施
Daily Harvest weekly
For 12 weeks, on the Daily Harvest weekly arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based company Daily Harvest weekly.
干预措施: Whole Foods Plant-based Diet (Other)
Supplements
For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.
干预措施: Algae Omega 3 + Curcumin (Dietary Supplement)
Placebo
For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).
干预措施: Placebo supplements (Other)
结局指标
主要结局
Stool microbiome diversity at 12 weeks
时间窗: 12 weeks
To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline
Stool microbiome diversity at 12 weeks
时间窗: 12 weeks
To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline
次要结局
未报告次要终点