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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05640843
Other study ID # 22-175
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 29, 2022
Est. completion date November 2026

Study information

Verified date May 2024
Source Memorial Sloan Kettering Cancer Center
Contact Urvi Shah, MD
Phone 646-608-3713
Email shahu@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Whole Foods Plant-based Diet
The meals will have a low glycemic index and contain 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 an online portal from Plantable which contains education materials and access to a health coach daily. 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
Dietary Supplement:
Algae omega 3
Algae omega 3 given twice daily.
Other:
Placebo supplements
Placebo supplements given twice daily.

Locations

Country Name City State
United States Memorial Sloan Kettering Basking Ridge (All Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (All Protocol Activities) Harrison New York
United States Memorial Sloan Kettering Monmouth (All Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (All Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (All Protocol Activities) Uniondale New York

Sponsors (6)

Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center M and M labs, Paula and Rodger Riney Foundation, Plantable, Sabinsa pharmaceuticals, VeggieDoctor

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in stool butyrate levels change in stool butyrate levels on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline 12 weeks
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