Trial Outcomes & Findings for A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM) (NCT NCT04920084)
NCT ID: NCT04920084
Last Updated: 2025-09-09
Results Overview
Weight loss is defined as the average decrease in BMI at 12 weeks
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-09-09
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
Baseline characteristics by cohort
| Measure |
Plant-based Meals
n=23 Participants
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.
|
|---|---|
|
Age, Continuous
|
62 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksWeight loss is defined as the average decrease in BMI at 12 weeks
Outcome measures
| Measure |
Plant-based Meals
n=20 Participants
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.
|
|---|---|
|
Difference of Body Mass Index From Baseline to Week 12
BMI at baseline
|
34.30 kg/m^2
Interval 30.52 to 38.5
|
|
Difference of Body Mass Index From Baseline to Week 12
BMI at 12 weeks
|
32 kg/m^2
Interval 26.7 to 36.82
|
PRIMARY outcome
Timeframe: 12 weeksIntervention 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).
Outcome measures
| Measure |
Plant-based Meals
n=20 Participants
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.
|
|---|---|
|
Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks
Adherence at baseline
|
21 percentage of WFPBD meals consumed
Interval 10.0 to 38.0
|
|
Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks
Adherence at 12 weeks
|
93 percentage of WFPBD meals consumed
Interval 84.0 to 96.0
|
Adverse Events
Plant-based Meals
Serious events: 14 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Plant-based Meals
n=23 participants at risk
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.
|
|---|---|
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Gastrointestinal disorders
Small intestinal obstruction
|
4.3%
1/23 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
4.3%
1/23 • 12 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
1/23 • 12 weeks
|
|
Blood and lymphatic system disorders
Febrile autoimmune neutropenia
|
4.3%
1/23 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • 12 weeks
|
|
Nervous system disorders
Indigestion/Dysgeusia
|
8.7%
2/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Polyps
|
4.3%
1/23 • 12 weeks
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
1/23 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.3%
1/23 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Herpes simplex reactivation
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Thrush
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Shingles
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Tooth infection
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Skin changes (dry, rash, hyperpigmentation)
|
13.0%
3/23 • 12 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
4.3%
1/23 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion/Rhinorrhea/Allergic rhinitis
|
13.0%
3/23 • 12 weeks
|
|
Vascular disorders
Hot flashes
|
8.7%
2/23 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain (back/extremity/bone)
|
26.1%
6/23 • 12 weeks
|
|
General disorders
Fatigue/weakness/dizziness/fall
|
26.1%
6/23 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnea
|
4.3%
1/23 • 12 weeks
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • 12 weeks
|
Other adverse events
| Measure |
Plant-based Meals
n=23 participants at risk
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.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.3%
1/23 • 12 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
1/23 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
8.7%
2/23 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
26.1%
6/23 • 12 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.3%
1/23 • 12 weeks
|
|
General disorders
Fatigue
|
13.0%
3/23 • 12 weeks
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
8.7%
2/23 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
1/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Thrush
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Shingles
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
UTI
|
4.3%
1/23 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.3%
1/23 • 12 weeks
|
|
Nervous system disorders
Dysgeusia
|
4.3%
1/23 • 12 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
4.3%
1/23 • 12 weeks
|
|
Vascular disorders
Hot flashes
|
4.3%
1/23 • 12 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Polyps
|
8.7%
2/23 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Herpes simplex reactivation
|
4.3%
1/23 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.3%
1/23 • 12 weeks
|
|
Gastrointestinal disorders
Indigestion
|
4.3%
1/23 • 12 weeks
|
|
Infections and infestations
Tooth infection
|
4.3%
1/23 • 12 weeks
|
Additional Information
Dr. Urvi Shah, MD, MS
Memorial Sloan Kettering Cancer Center
Phone: 646-608-3713
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place