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Multicultural Healthy Diet for Chronic Kidney Disease
N/A
Recruiting
Research Sponsored by Montefiore Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
CKD stage 3 (estimated glomerular filtration rate (GFR) < 60 - >30 ml/min/1.73m2)
Age ≥18 years
Must not have
CKD stage 4 or higher (eGFR <30 ml/min/1.73 m2)
Uncontrolled hypertension (BP >150 /90 mmHg)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months post baseline
Awards & highlights
No Placebo-Only Group
Summary
This trial will test whether a diet designed to reduce inflammation is feasible and acceptable for people with kidney disease.
Who is the study for?
This trial is for adults over 18 living in the Bronx who speak English or Spanish and have moderate chronic kidney disease (stage 3). They must be willing to change their diet, not have severe illnesses that would interfere with the study, and cannot have very high potassium levels or poorly controlled diabetes.
What is being tested?
The study is testing a culturally-tailored anti-inflammatory diet designed specifically for people from diverse backgrounds with chronic kidney disease. It aims to see if participants find this diet manageable and acceptable.
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments as the body adapts to new foods. Specific side effects will depend on individual health conditions and dietary responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My kidney function is moderately reduced.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is severely reduced.
Select...
My blood pressure is not higher than 150/90 mmHg.
Select...
I have had high potassium levels or my current potassium level is above 4.6.
Select...
My diabetes is not well-managed, with HbA1c over 9% or I use insulin.
Select...
I have had a kidney transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 months post baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months post baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability
Feasibility of dietary intervention
Other study objectives
Potassium
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: All participants will receive the interventionExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,464 Previous Clinical Trials
4,337,433 Total Patients Enrolled
Montefiore Medical CenterLead Sponsor
458 Previous Clinical Trials
588,594 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My kidney function is severely reduced.My blood pressure is not higher than 150/90 mmHg.You do not want to change your diet for the study.I have had high potassium levels or my current potassium level is above 4.6.My kidney function is moderately reduced.I speak English or Spanish.My diabetes is not well-managed, with HbA1c over 9% or I use insulin.I am 18 years old or older.You have a serious long-term illness or difficulty reading and understanding information, or you cannot make changes to your diet or complete the study tasks.I have had a kidney transplant.
Research Study Groups:
This trial has the following groups:- Group 1: All participants will receive the intervention
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.