Plant-Based Diet With 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

Disqualifiers: Whole foods plant diet, Legume allergy, Severe nut allergies, Concurrent programs, Mental impairment, Other study enrollment, Pregnancy, Positive HBV/HCV/HIV, Electrolyte abnormalities, Heavy drinker, Illicit drug use, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how a plant-based diet, combined with omega-3 (from algae) and curcumin supplements, affects butyrate levels in the stool of participants with specific blood conditions. Butyrate is a compound linked to gut health. Participants will follow a plant-based diet for 12 weeks and may receive either the supplements or a placebo (a harmless pill with no active ingredients). This study targets individuals diagnosed with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM) who are interested in learning to cook plant-based meals. Participants should not already follow a whole foods plant-based diet and should not have severe nut allergies.

As an unphased trial, this study provides participants the opportunity to explore the potential health benefits of dietary changes in a supportive research environment.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, you cannot be enrolled in any other therapeutic investigational study concurrently or up to 180 days before the study starts.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a diet focused on whole plant foods is generally safe and may provide health benefits. Studies suggest that this type of diet can lower the risk of multiple myeloma, a kind of blood cancer, and there are no major reports of negative effects from following it.

Regarding the supplements in the trial, omega-3 fatty acids from algae are often used in products like baby formulas and are generally considered safe. Lab studies have indicated that these supplements might help fight myeloma cells without damaging normal cells. Curcumin, found in turmeric, is also commonly used in cooking and supplements. It is mostly safe but can sometimes cause mild issues like an upset stomach.

Overall, the treatments studied in this trial have a good safety record. Based on existing research, participants can generally expect these options to be well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for multiple myeloma because they offer a plant-based approach, focusing on diet and supplements, which is quite different from traditional chemotherapy and stem cell transplants. The Daily Harvest meal plan provides patients with whole, plant-based foods that are easy to prepare, potentially improving nutritional intake without the side effects typical of conventional drugs. Additionally, the supplement arm introduces algae omega-3 and curcumin, which are natural compounds known for their anti-inflammatory properties, offering a novel way to support the body’s fight against cancer. These treatments aim to enhance overall well-being and may offer a gentler alternative to existing therapies.

What evidence suggests that this trial's treatments could be effective for multiple myeloma?

Research has shown that a plant-based diet can positively affect conditions like multiple myeloma, a type of blood cancer. One study found that diets high in fiber from plants might slow the progression of this cancer. Consuming whole grains, fruits, and vegetables has shown promise in managing myeloma. In this trial, some participants will follow a Whole Foods Plant-based Diet, receiving premade meals from Daily Harvest.

Omega-3 fatty acids, found in algae supplements, have also been researched for their impact on myeloma. Lab studies indicate that these fatty acids can slow myeloma cell growth. They might even enhance the effectiveness of certain cancer drugs by helping to destroy myeloma cells. In this trial, another group of participants will receive algae omega-3 supplements, while a separate group will receive placebo supplements. ^{1 5 6 7 8}

Who Is on the Research Team?

Urvi Shah, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Adults diagnosed with MGUS or SMM who are interested in a plant-based diet and willing to follow study procedures can join. They must have specific blood protein levels based on their condition type, be able to cook plant-based recipes, and not already be on such a diet. Exclusions include drug use, other clinical trials participation, severe food allergies, heavy alcohol consumption, certain infections needing treatment first.

Inclusion Criteria

Your blood or bone marrow test results show specific abnormal levels related to a condition called MGUS or SMM.

This criterion seems to be unrelated to clinical trial exclusion criteria. Could you please provide more details or context for this criterion?

Willingness to comply with all study-related procedures

Exclusion Criteria

You currently use illegal drugs like heroin or cocaine (not marijuana).

You are currently pregnant.

I am mentally capable of cooperating with treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a plant-based diet, omega-3 and curcumin supplements, or placebo for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Algae omega 3
• Placebo supplements
• Whole Foods Plant-based Diet

Trial Overview The trial is testing the effects of a whole foods plant-based diet supplemented with omega-3 from algae and curcumin versus placebo supplements on butyrate levels in stool over at least 12 weeks for those with MGUS or SMM.

How Is the Trial Designed?

Group I: Supplements Experimental Treatment 1 Intervention

For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.

Group II: Daily Harvest weekly Experimental Treatment 1 Intervention

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.

Group III: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Daily Harvest

Collaborator

Plantable

Collaborator

Trials

1

Recruited

150+

Sabinsa pharmaceuticals

Collaborator

Trials

1

Recruited

150+

Paula and Rodger Riney Foundation

Collaborator

Trials

1

Recruited

150+

VeggieDoctor

Collaborator

Trials

1

Recruited

150+

M and M labs

Collaborator

Trials

1

Recruited

150+

Published Research Related to This Trial

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]

A survey of 668 medical students and family medicine residents revealed that only 22% felt they received adequate nutrition education, highlighting a significant gap in training.

41% of respondents believed that a whole-foods, plant-based (WFPB) diet should be emphasized in their education, suggesting that incorporating such dietary training could enhance future physicians' ability to address obesity-related chronic diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Place for Plant-Based Nutrition in US Medical School Curriculum: A Survey-Based Study. Morton, KF., Pantalos, DC., Ziegler, C., et al.[2022]

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]

A study involving 179 cases of multiple myeloma and 691 controls found that higher consumption of cooked tomatoes, cruciferous vegetables, fresh fish, and vitamin A is associated with a reduced risk of developing multiple myeloma.

Conversely, the intake of cream soups, jello, ice cream, and pudding was linked to an increased risk of multiple myeloma, suggesting that certain dietary choices may influence cancer risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diet and risk of multiple myeloma in Connecticut women. Hosgood, HD., Baris, D., Zahm, SH., 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 a study involving 69,751 women and 47,232 men over 2,792,257 person-years, a higher empirical dietary inflammatory pattern (EDIP) was linked to a 16% increased risk of multiple myeloma (MM) in men, suggesting that inflammatory diets may contribute to MM development.

No significant associations were found between dietary patterns and MM risk in women, indicating that the relationship between diet and MM may be more pronounced in men and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary Pattern and Risk of Multiple Myeloma in Two Large Prospective US Cohort Studies. Lee, DH., Fung, TT., Tabung, FK., et al.[2022]

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 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 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]

Over half of adults in the US use dietary supplements, which are less regulated than pharmaceuticals, leading to potential risks from unreported herbal products that may contain toxic substances and interact negatively with medications.

Physicians need to be knowledgeable about herbal supplements and functional foods, as many have proven health benefits and can play a role in disease prevention, particularly in relation to vascular diseases and cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dietary supplements and functional foods: 2 sides of a coin? Halsted, CH.[2022]

Citations

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Omega-3 fatty acids, EPA and DHA induce apoptosis ... Omega-3 fatty acids, EPA and DHA induce apoptosis and enhance drug sensitivity in multiple myeloma cells but not in normal peripheral mononuclear cells.

2. youtube.com youtube.com/watch?v=pSEuhTQZ7t8

What should individuals living with #myeloma and smoldering ... #HTUmyeloma Omega-3 fatty acids have been shown in the lab to inhibit the growth of myeloma cells. Although the clinical data is limited, ...

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Effects of the polyunsaturated fatty acids, EPA and DHA, on ... Omega-3 FAs have been shown to have strong anti-proliferative and differentiation promoting effects [21, 22]. A natural lipid preparation rich in EPA and DHA ( ...

4. researchgate.net researchgate.net/publication/344407853_The_efficacy_of_bortezomib_in_human_multiple_myeloma_cells_is_enhanced_by_combination_with_omega-3_fatty_acids_DHA_and_EPA_Timing_is_essential

The efficacy of bortezomib in human multiple myeloma ... The efficacy of bortezomib in human multiple myeloma cells is enhanced by combination with omega-3 fatty acids DHA and EPA: Timing is essential.

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The Effect of Algae Oil Supplements on Functional Immune ... The outcomes of this exploratorive study will provide insight into the variation between individuals and potential effect sizes, and will aim to conduct more ...

6. webmd.com webmd.com/vitamins/ai/ingredientmono-1565/algal-oil

Algal Oil - Uses, Side Effects, and More Algal oil is included as a source of DHA in some infant formula. It is generally recognized as safe for this use.

7. oncotarget.com oncotarget.com/article/24405/text/

Effects of the polyunsaturated fatty acids, EPA and DHA, on ... We performed a systematic review of the beneficial effects of EPA and DHA on hematological cell lines as well as the findings of related in vivo studies and ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10443185/

Dietary and microbiome evidence in multiple myeloma ... In this article, we provide a detailed review of dietary and microbiome factors involved in the pathogenesis of MM and their impact on outcomes.