Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will test whether a plant-based diet is practical (feasible) for overweight people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The researchers will decide how practical the diet is by looking at how much weight participants lose and how well they are able to stick to the diet. The researchers will also determine whether the diet is effective in preventing multiple myeloma in participants. In addition, they will look at how safe the plant-based diet is for participants, and see if the diet affects participants' quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant-based meals | Experimental | Patients who will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.Participants will be asked to complete a survey via MSK Engage and a notification will be sent via email notification. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant based meals | Other | For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. 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 coach daily for 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference of Body Mass Index From Baseline to Week 12 | Weight loss is defined as the average decrease in BMI at 12 weeks | 12 weeks |
| Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks | Intervention defined as ≥70% of participants consuming a whole food, plant-based diet/WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey). | 12 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Urvi A Shah, MD, MS | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan Kettering Monmouth |
Not provided
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
Not provided
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Plant-based Meals | Patients who will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.Participants will be asked to complete a survey via MSK Engage and a notification will be sent via email notification. Plant based meals: For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. 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 coach daily for 24 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 27, 2024 |
Not provided
This is a single-arm, single-center pilot.
Not provided
Not provided
Not provided
Not provided
|
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Bergen | Montvale | New Jersey | 07645 | United States |
| Memorial Sloan Kettering Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Nassau | Uniondale | New York | 11553 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Plant-based Meals | Patients who will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.Participants will be asked to complete a survey via MSK Engage and a notification will be sent via email notification. Plant based meals: For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. 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 coach daily for 24 weeks. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Difference of Body Mass Index From Baseline to Week 12 | Weight loss is defined as the average decrease in BMI at 12 weeks | Posted | Median | Inter-Quartile Range | kg/m^2 | 12 weeks |
|
|
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks | Intervention defined as ≥70% of participants consuming a whole food, plant-based diet/WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey). | Posted | Median | Inter-Quartile Range | percentage of WFPBD meals consumed | 12 weeks |
|
|
12 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plant-based Meals | Patients who will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.Participants will be asked to complete a survey via MSK Engage and a notification will be sent via email notification. Plant based meals: For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. 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 coach daily for 24 weeks. | 1 | 23 | 14 | 23 | 15 | 23 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Febrile autoimmune neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Indigestion/Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Polyps | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Herpes simplex reactivation | Infections and infestations | Systematic Assessment |
| ||
| Thrush | Infections and infestations | Systematic Assessment |
| ||
| Shingles | Infections and infestations | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
| ||
| Urinary tract infection | Infections and infestations | Systematic Assessment |
| ||
| Skin changes (dry, rash, hyperpigmentation) | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Nasal congestion/Rhinorrhea/Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Anxiety | Psychiatric disorders | Systematic Assessment |
| ||
| Pain (back/extremity/bone) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Fatigue/weakness/dizziness/fall | General disorders | Systematic Assessment |
| ||
| Sleep apnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile Neutropenia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Acute kidney injury | Renal and urinary disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Sinus pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Thrush | Infections and infestations | Systematic Assessment |
| ||
| Shingles | Infections and infestations | Systematic Assessment |
| ||
| UTI | Infections and infestations | Systematic Assessment |
| ||
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Dysgeusia | Nervous system disorders | Systematic Assessment |
| ||
| Tinnitus | Ear and labyrinth disorders | Systematic Assessment |
| ||
| Hot flashes | Vascular disorders | Systematic Assessment |
| ||
| Polyps | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Herpes simplex reactivation | Infections and infestations | Systematic Assessment |
| ||
| Rash acneiform | Skin and subcutaneous tissue disorders | Systematic Assessment |
| ||
| Indigestion | Gastrointestinal disorders | Systematic Assessment |
| ||
| Tooth infection | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Urvi Shah, MD, MS | Memorial Sloan Kettering Cancer Center | 646-608-3713 | shahu@mskcc.org |
| Aug 23, 2024 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 11, 2022 | Aug 27, 2025 | ICF_001.pdf |
| ID | Term |
|---|---|
| D008998 | Monoclonal Gammopathy of Undetermined Significance |
| D000075122 | Smoldering Multiple Myeloma |
| ID | Term |
|---|---|
| D006942 | Hypergammaglobulinemia |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D010265 | Paraproteinemias |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|