A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)

Conditions

• Monoclonal Gammopathy of Undetermined Significance
• Smoldering Multiple Myeloma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Whole Foods Plant-based Diet — OTHER
  The meals will have a low glycemic index and contain legumes, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to education materials. Patients will also receive dietary education and counselling from a research dietitian every 4 weeks for the 12-week intervention period. They will have access to the team for questions and support as needed
• Algae Omega 3 + Curcumin — DIETARY_SUPPLEMENT
  For 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily
• Placebo supplements — OTHER
  For 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals).

Study Details

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.

Key Dates

Start date

Nov 29, 2022

Status verified

Apr 2026

Primary completion

Nov 30, 2026

Completion

Nov 30, 2026

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: 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.
• Experimental: 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.
• Placebo Comparator: Placebo
  For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).

Primary Outcome Measure

Stool microbiome diversity at 12 weeks [ Time Frame: 12 weeks ]

Central Contacts

• Urvi A Shah, MD, MS
  646-608-3713
  [email protected]
• Alexander Lesokhin, MD
  646-608-3717

Locations (8)

Find similar trials in Atlanta, GA

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