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Behavioural Intervention

Intervention Group for Chronic Lymphocytic Leukemia

N/A

Recruiting

Led By Ariel Portera, DO

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients who have a diagnosis of low-risk CLL according to the modified Rai staging criteria for a minimum of 12 months and are currently undergoing observation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 year

Awards & highlights

Study Summary

This trial will test if a vegan diet can be followed by people with low risk CLL who are not undergoing treatment. Participants will attend online cooking classes and have individual meetings with health coaches to help them stick

Who is the study for?

This trial is for individuals with low-risk Chronic Lymphocytic Leukemia (CLL) who are currently not undergoing treatment but are being observed. Participants should be willing to attend weekly online cooking classes and meetings with health coaches for 8 weeks to adhere to a vegan whole-food, plant-based diet.Check my eligibility

What is being tested?

The study is testing the practicality of following an 8-week whole-food, plant-based diet among patients with CLL. It involves group cooking classes and personal coaching sessions each week to help participants stick to the dietary plan.See study design

What are the potential side effects?

Since this intervention involves a dietary change rather than medication, side effects may include changes in digestion or energy levels as the body adjusts to a new eating pattern.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have low-risk CLL and have been under observation for at least 12 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to the Dietary Intervention

Cooking Class Adherence

Recruitment

+2 more

Secondary outcome measures

Absolute lymphocyte count

Anthropometric Measures (height, weight, body mass index)

Anthropometric Measures (waist circumference)

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Intervention GroupExperimental Treatment1 Intervention

Subjects will be instructed to adopt a whole-food, plant-based diet for 8 weeks. They will attend weekly group cooking classes led by a RD and receive weekly health coaching sessions.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,126 Previous Clinical Trials

1,552,973 Total Patients Enrolled

Ariel Portera, DOPrincipal InvestigatorUC San Diego

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of participants currently under investigation in this clinical study?

"Indeed, records on clinicaltrials.gov affirm that this research investigation is presently enrolling participants. The study was initially disclosed on March 7th, 2023 and last revised on April 17th, 2024. Enrollment aims to recruit a total of 18 subjects from one designated site."

Answered by AI

Is the enrollment phase of this medical study currently ongoing?

"Indeed, according to the information presented on clinicaltrials.gov, this particular clinical trial is actively in need of volunteers. The initial posting date for the trial was 3/7/2023 with the most recent update noted as 4/17/2024. This investigation aims to recruit a total of 18 participants from a single designated site."

Answered by AI

What are the main goals and purposes of this clinical investigation?

"During the 8-week monitoring period, this study aims to assess Retention as its primary goal. Secondary objectives involve evaluating ferritin levels using conventional techniques, blood pressure (including systolic and diastolic readings) through standard measurements, and Anthropometric Measures such as waist circumference utilizing established methods. Additionally, BMI will be calculated by combining weight and height in kg/m^2."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)

Ariel Portera 2023. "Feasibility of a Whole-Food, Plant-Based Diet for Patients With Low-Risk Chronic Lymphocytic Leukemia (CLL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06377501.

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