A Dietary Study for People With Clonal Hematopoiesis
12 maj 2026 uppdaterad av: Memorial Sloan Kettering Cancer Center
A Decentralized High-Fiber Dietary Intervention Trial in Clonal Hematopoiesis - NUTRIVENTION-CH
The researchers are doing this study to find out whether a high-fiber plant-based diet (HFPBD) can improve quality of life for people with CH.
A HFPBD includes foods that are mainly from plants (for example, fruits,vegetables, nuts, beans, and whole grains).
The researchers will measure quality of life by having participants complete questionnaires/surveys.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
36
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Urvi Shah, MD
- Telefonnummer: 646-608-3713
- E-post: ShahNutrivention@mskcc.org
Studera Kontakt Backup
- Namn: Tamanna Haque, MD
- Telefonnummer: 646-608-4166
Studieorter
-
-
New Jersey
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Basking Ridge, New Jersey, Förenta staterna, 07920
- Rekrytering
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
-
Kontakt:
- Urvi Shah, MD
- Telefonnummer: 646-608-3713
-
Middletown, New Jersey, Förenta staterna, 07748
- Rekrytering
- Memorial Sloan Kettering Monmouth (All Protocol Activities)
-
Kontakt:
- Urvi Shah, MD
- Telefonnummer: 646-608-3713
-
Montvale, New Jersey, Förenta staterna, 07645
- Rekrytering
- Memorial Sloan Kettering Bergen (All Protocol Activities)
-
Kontakt:
- Urvi Shah, MD
- Telefonnummer: 646-608-3713
-
-
New York
-
Commack, New York, Förenta staterna, 11725
- Rekrytering
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
-
Kontakt:
- Urvi Shah, MD
- Telefonnummer: 646-608-3713
-
Harrison, New York, Förenta staterna, 10604
- Rekrytering
- Memorial Sloan Kettering Westchester (All Protocol Activities)
-
Kontakt:
- Urvi Shah, MD
- Telefonnummer: 646-608-3713
-
New York, New York, Förenta staterna, 10065
- Rekrytering
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)
-
Kontakt:
- Urvi Shah, MD
- Telefonnummer: 646-608-3713
- E-post: ShahNutrivention@mskcc.org
-
Kontakt:
- Tamanna Haque, MD
- Telefonnummer: 646-608-4166
-
Uniondale, New York, Förenta staterna, 11553
- Rekrytering
- Memorial Sloan Kettering Nassau (All Protocol Activities)
-
Kontakt:
- Urvi Shah, MD
- Telefonnummer: 646-608-3713
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Patients must have confirmed clonal hematopoiesis via next generation sequencing (NGS) of blood or bone marrow biopsy sample
- Patients with clonal cytopenias of undetermined significance (CCUS) are eligible if a bone marrow biopsy is done to exclude other causes.
- Variant allele frequency must be ≥2% for mutation as measured by (NGS)
- Treatment at MSK or at sites listed below that uses EPIC for electronic medical records and willing to share records with MSK through EPIC's care everywhere or through MSK's shared care network. If not meeting this criterion, decision to allow for participation is per PI discretion.
- Age ≥ 18 years
- BMI ≥25 kg/m^2
- Participant or caregiver must be able to complete surveys and have interest in trying new recipes or cooking.
- Screening 24-hour dietary recall must consume <30 grams dietary fiber per day to be eligible (any one of two 24-hour screening dietary recalls).
- For patients at MSK, require bone marrow biopsy at screening in the past 24 weeks with collection of research biobanking sample. Bone marrow at other sites is optional.
Exclusion Criteria:
- Prior MDS/AML directed therapy
- Chemotherapy, radiation, or immunotherapy within the past year (surgical- resection only or other cancer/precancer on observation is eligible)
- Patients with a concurrent malignancy whose natural history or treatment may compromise completion of this trial are excluded.
- Concurrent pregnancy will make a participant ineligible to participate
- Patients that already follow a minimally processed (whole food) plant-based diet in the last 3 months are not eligible (ovo-lacto-vegetarian or processed junk food vegan diets are eligible).
- Patients on GLP-1 drugs are eligible if it has been started at least 3 months prior to study and on stable dose. If it has been started more recently for diabetes mellitus control but not weight loss they are eligible. If it is medically indicated and started for diabetes mellitus control while on trial they will not be removed/excluded from trial.
- Mental impairment leading to inability to cooperate will lead to exclusion from trial participation.
- 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.
- Concurrent weight loss or dietary programs will be ineligible if require a specific diet or weight loss supplements.
- Plan for prolonged travel during the study that would preclude adherence to prescribed diet. Willingness to comply during travel is not an exclusion.
- Severe allergy to any legume (such as anaphylactic shock) or allergies to multiple legumes or if cross-contamination is a risk are not eligible.
- Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews are not eligible.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: High Fiber Plant-Based Diet
Participants will have a phone call or video call with a dietitian every 2 weeks for the first 12 weeks, every 4 weeks from Weeks 13-24, and every 8 weeks from Weeks 25-52. Participants will receive high-fiber plant-based meals for 12 weeks |
A meal service will ship 12 frozen prepared meals per week to your home.
Fermented foods will be encouraged on the diet.
Fermented foods contain probiotics that help support a balanced gut microbiome and might improve overall digestion.
Patients will be recommended by research dietitian to take a weekly vitamin B12 supplement (at least 500 mcg weekly)
QOL will be measured with the EORTC QLQ C30
|
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Aktiv komparator: Usual care arm
Participants will have phone calls with a member of the study team every 4 weeks for the first 12 weeks.
After the first 12 weeks, participants will have a phone call or video call with a dietitian at Weeks 13 and 53 (end of study).
|
QOL will be measured with the EORTC QLQ C30
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
compare the rates of improvement in Quality Of Life
Tidsram: up to 12 weeks
|
using the Quality of Life Global Health Status at W13D1 Scoring will be based on standard EORTC criteria
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up to 12 weeks
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Urvi Shah, MD, Memorial Sloan Kettering Cancer Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
4 maj 2026
Primärt slutförande (Beräknad)
1 maj 2027
Avslutad studie (Beräknad)
1 maj 2027
Studieregistreringsdatum
Först inskickad
7 maj 2026
Först inskickad som uppfyllde QC-kriterierna
12 maj 2026
Första postat (Faktisk)
15 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
15 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26-086
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
JA
IPD-planbeskrivning
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.
Läkemedels- och apparatinformation, studiedokument
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Nej
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Nej
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