Plant-Based Diet + Supplements for Multiple Myeloma

Recruiting at 7 trial locations

Overseen By Urvi Shah, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Supplements, Weight loss drugs

Disqualifiers: Legume allergy, Severe allergies, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to look at how butyrate levels change in participants' stool after they are on a plant-based diet or dietary supplements (omega-3, curcumin or probiotics) for 2 weeks. All participants will have smoldering multiple myeloma (SMM). The researchers will compare how the different dietary changes affect butyrate levels in participants' stool.

Will I have to stop taking my current medications?

The trial requires participants to stop taking certain supplements like curcumin, probiotics, and omega-3 for 2 weeks before joining. However, it does not specify stopping other medications, so you may not need to stop your current medications unless they fall under specific exclusions like prescription weight loss drugs or therapeutic myeloma drugs.

What data supports the effectiveness of this treatment for multiple myeloma?

Research suggests that healthier dietary patterns, including plant-based diets, may improve survival in multiple myeloma patients by reducing inflammation. Additionally, plant-based diets can positively affect the gut microbiome, potentially enhancing immune function and contributing to better outcomes in multiple myeloma. ^{1 2 3 4 5}

Is a whole-food plant-based diet generally safe for humans?

A whole-food plant-based diet is generally considered safe for most people and is associated with improved health outcomes. However, it may not meet the recommended levels of vitamin B12, vitamin D, and calcium for older women without supplementation. ^{6 7 8 9 10}

How does a plant-based diet differ from other treatments for multiple myeloma?

A plant-based diet for multiple myeloma is unique because it focuses on dietary changes that may reduce inflammation and improve gut health, potentially influencing disease outcomes. Unlike traditional drug treatments, this approach emphasizes consuming whole foods and high fiber, which can enhance the gut microbiome and produce beneficial compounds like butyrate, possibly leading to better disease management. ^{1 2 3 5 11}

Research Team

Urvi Shah, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults over 18 with smoldering multiple myeloma who are willing to follow a plant-based diet or take dietary supplements. They must be able to prepare meals, send stool samples, and use the Keenoa app. Exclusions include those on certain medications, following a whole foods plant-based diet already, with severe allergies or gastrointestinal issues, heavy alcohol or illicit drug users.

Inclusion Criteria

This criterion is not related to clinical trial exclusion criteria. If you have any other clinical trial exclusion criteria that you would like me to simplify, feel free to share them with me.

I am 18 years old or older.

I can do, or have someone to help with, study tasks like cooking and sending samples.

Exclusion Criteria

My electrolyte levels (sodium and potassium) are now normal.

You are already following a specific healthy diet, but not junk food vegan or ovo-lactovegetarian diets.

You are allergic to legumes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants follow a plant-based diet or receive dietary supplements (omega-3, curcumin, or probiotics) for 2 weeks

2 weeks

Telehealth visits for dietary guidance and data collection

Follow-up

Participants are monitored for adherence and changes in stool butyrate levels

2 weeks

Telehealth visits for adherence assessment and stool sample collection

Treatment Details

Interventions

• Curcumin
• Omega-3
• Probiotic
• Whole food, plant-based diet (WFPBD)

Trial Overview The study tests how a whole food plant-based diet and supplements like Omega-3, Curcumin, and Probiotics affect butyrate levels in stool of people with smoldering multiple myeloma over two weeks. Participants will document their experience using an app.

Participant Groups

Group I: Whole food, plant-based diet (WFPBD) Experimental Treatment 1 Intervention

For 2 weeks, on the WFPBD arm, patients will receive 14 items weekly, prepared and shipped by U.S. based company, Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch/dinners, 1 snack (provided Week 1), and whole grains items (provided Week 2). The meals will contain legumes, fruits, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for additional meals outside those given by Daily Harvet meeting the standard of a WFPBD will also be given to supplement their individual daily calorie needs through the guidance of the research dietitian. Patients will receive a varied menu created by Daily Harvest and the study team on a weekly basis.

Group II: Probiotic Experimental Treatment 1 Intervention

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily from Vita Miracle pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

Group III: Omega-3 Experimental Treatment 1 Intervention

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily Qwell™ Omega 3 by The Veggie Doctor™. Each 820 mg omega 3 supplement capsule contains 700 mg Docosohexaenoic acid, 100 mg Docosapentaenoic acid, and 20 mg Eicosapentaenoic acid. No dietary changes will be made but data on dietary intake will be collected.

Group IV: Curcumin Experimental Treatment 1 Intervention

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily from Sabinsa pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

HealthTree Foundation

Collaborator

Trials

2

Recruited

1,600+

Findings from Research

A study of 423 multiple myeloma patients showed that healthier dietary patterns, such as those reflected in the Alternate Healthy Eating Index, are associated with a 15-24% lower risk of MM-specific mortality, suggesting that diet may influence survival outcomes.

Conversely, patients with less healthy dietary habits, indicated by higher scores in the Western dietary pattern, experienced a 16-24% increase in MM-specific mortality, highlighting the potential impact of diet on disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediagnosis dietary pattern and survival in patients with multiple myeloma. Lee, DH., Fung, TT., Tabung, FK., et al.[2022]

In a study of 61 patients with multiple myeloma, those with low carbohydrate intake showed significant improvements in clinical parameters like hemoglobin and albumin compared to those with medium carbohydrate intake, suggesting that diet quality may influence disease outcomes.

Despite the observed effects of diet on clinical parameters, patients' nutrition knowledge did not correlate with their clinical status or nutrient intake, indicating a need for better nutritional education and personalized dietary advice for improving patient health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High Carbohydrate Diet Is Associated with Severe Clinical Indicators, but Not with Nutrition Knowledge Score in Patients with Multiple Myeloma. Borsi, E., Serban, CL., Potre, C., et al.[2021]

In the NIH-AARP Diet and Health study, which included 392,589 participants and identified 1,366 cases of multiple myeloma (MM), a healthful plant-based diet was associated with a reduced risk of developing MM, suggesting dietary choices may influence cancer risk.

While the association between a healthful plant-based diet and reduced MM risk was significant, it became less clear in sensitivity analyses, indicating that further research is needed to confirm these findings, especially since MM is a rare disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pre-Diagnosis Dietary Patterns and Risk of Multiple Myeloma in the NIH-AARP Diet and Health Study. Castro, F., Parikh, R., Eustaquio, JC., et al.[2023]

In a study of 5,764 participants, consuming fruit at least three times a week during adolescence was linked to a lower risk of developing monoclonal gammopathy of undetermined significance (MGUS), with an odds ratio of 0.62.

Additionally, higher fruit intake in late life was associated with a significantly reduced risk of progression from MGUS to multiple myeloma (MM), with a hazard ratio of 0.34, suggesting that diet may play a role in both the development and progression of these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary intake is associated with risk of multiple myeloma and its precursor disease. Thordardottir, M., Lindqvist, EK., Lund, SH., et al.[2019]

Higher levels of stool butyrate and butyrate-producing bacteria, as well as greater microbiome diversity, were linked to sustained minimal residual disease (MRD) negativity in multiple myeloma patients, suggesting a potential role of gut health in cancer outcomes.

A plant-based diet rich in healthy proteins and flavonoids was associated with increased stool butyrate levels and sustained MRD negativity, indicating that dietary factors may influence treatment effectiveness in multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sustained Minimal Residual Disease Negativity in Multiple Myeloma is Associated with Stool Butyrate and Healthier Plant-Based Diets. Shah, UA., Maclachlan, KH., Derkach, A., et al.[2023]

A healthful diet should focus on a variety of whole, unprocessed foods, emphasizing fresh fruits, vegetables, whole grains, nuts, seeds, and legumes, while minimizing additives and harmful agricultural chemicals.

Vegetarians can have a lower risk of chronic diseases compared to omnivores, but they need to plan their diets carefully to avoid nutritional deficiencies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the fundamentals of diet. Gaby, A.[2021]

A community-based dietary program using a whole food plant-based (WFPB) diet resulted in a significant reduction in BMI after 6 months, with an average decrease of 4.4 kg/m² compared to only 0.4 kg/m² in the control group.

Participants following the WFPB diet also experienced a meaningful reduction in cholesterol levels, achieving a significant decrease at 12 months, with no serious harms reported, indicating the diet's safety and potential efficacy for improving health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. Wright, N., Wilson, L., Smith, M., et al.[2018]

Whole-food plant-based (WFPB) meal plans scored 88 out of 100 on the Healthy Eating Index (HEI-2015), indicating a high overall dietary quality with significantly more vegetables, fruits, and whole grains compared to typical US diets.

However, WFPB diets do not meet the Recommended Dietary Allowances (RDAs) for vitamin B12 and D without supplementation, and calcium intake is insufficient for women aged 51-70, highlighting the need for careful nutrient management in these diets.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theoretical Food and Nutrient Composition of Whole-Food Plant-Based and Vegan Diets Compared to Current Dietary Recommendations. Karlsen, MC., Rogers, G., Miki, A., et al.[2020]

A new Plant-Based Diet (PBD) scoring system was developed to evaluate adherence to PBDs in Japanese patients with inflammatory bowel disease (IBD), showing significant differences in scores based on dietary types.

Patients with Crohn disease who maintained a high PBD score (25 or greater) were more likely to achieve long-term remission and have normal C-reactive protein levels, indicating a potential link between PBD adherence and improved health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Application of a Plant-Based Diet Scoring System for Japanese Patients with Inflammatory Bowel Disease. Chiba, M., Nakane, K., Takayama, Y., et al.[2019]

A study involving 200 medical trainees and 52 patients found that nearly half of the patients were open to trying a whole-foods, plant-based (WFPB) diet for managing chronic diseases, indicating a potential for dietary intervention in improving health outcomes.

While over half of the trainees were willing to recommend a WFPB diet, they expressed concerns about its acceptability and feasibility, highlighting the need for medical providers to address their assumptions and provide better support for patients considering dietary changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Whole-Foods, Plant-Based Diet Perceptions of Medical Trainees Compared to Their Patients: A Cross-Sectional Pilot Study. Morton, KF., Pantalos, DC., Ziegler, C., et al.[2023]

In a study of 30 multiple myeloma patients undergoing autologous stem cell transplantation, a significant loss of gut microbiome diversity was observed at the engraftment stage, which was linked to the use of intravenous antibiotics.

Lower gut microbiome diversity at engraftment correlated with a poorer response to therapy, suggesting that maintaining a diverse gut microbiome may be important for improving treatment outcomes in multiple myeloma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perturbation of the gut microbiome and association with outcomes following autologous stem cell transplantation in patients with multiple myeloma. D'Angelo, C., Sudakaran, S., Asimakopoulos, F., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Prediagnosis dietary pattern and survival in patients with multiple myeloma. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

High Carbohydrate Diet Is Associated with Severe Clinical Indicators, but Not with Nutrition Knowledge Score in Patients with Multiple Myeloma. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Pre-Diagnosis Dietary Patterns and Risk of Multiple Myeloma in the NIH-AARP Diet and Health Study. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Dietary intake is associated with risk of multiple myeloma and its precursor disease. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Sustained Minimal Residual Disease Negativity in Multiple Myeloma is Associated with Stool Butyrate and Healthier Plant-Based Diets. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

A review of the fundamentals of diet. [2021]

7. England pubmed.ncbi.nlm.nih.gov

The BROAD study: A randomised controlled trial using a whole food plant-based diet in the community for obesity, ischaemic heart disease or diabetes. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Theoretical Food and Nutrient Composition of Whole-Food Plant-Based and Vegan Diets Compared to Current Dietary Recommendations. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Development and Application of a Plant-Based Diet Scoring System for Japanese Patients with Inflammatory Bowel Disease. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Whole-Foods, Plant-Based Diet Perceptions of Medical Trainees Compared to Their Patients: A Cross-Sectional Pilot Study. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Perturbation of the gut microbiome and association with outcomes following autologous stem cell transplantation in patients with multiple myeloma. [2023]