Multicultural Healthy Diet in Chronic Kidney Disease

Study Overview
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Brief Summary
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This is a pilot intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention in participants with chronic kidney disease.

Detailed Description
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This is a pilot pre-post comparison intervention study to evaluate the feasibility and acceptability of a culturally-tailored anti-inflammatory diet intervention. The study will recruit 20 adult participants with chronic kidney disease (CKD) from nephrology clinics in the Bronx. The diet emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention will be delivered by an experienced nutritionist with expertise providing dietary counseling to patients with CKD. The investigative team will assess whether the diet is feasible, acceptable, and safe in patients with CKD through dietary intake assessments, questionnaires and serum biomarkers. Information from study will help inform the study design and intervention of a future large-scale, study aimed at improving CKD outcomes. The clinical site for the proposed study is at the Albert Einstein College of Medicine and Montefiore Medical Center.

Official Title
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The Feasibility and Acceptability of a Multicultural Healthy Diet (Anti-inflammatory Dietary Pattern) in Racial/Ethnic Minorities With Chronic Kidney Disease

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: Multicultural Health Diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 years CKD stage 3 (estimated glomerular filtration rate (GFR) < 60 - >30 ml/min/1.73m2) Residency in the Bronx English or Spanish speaking Provide written informed consent Exclusion Criteria: History of hyperkalemia, or baseline serum K > 4.6 CKD stage 4 or higher (eGFR <30 ml/min/1.73 m2) Unwillingness to make dietary changes History of kidney transplant Poorly controlled diabetes (HbA1c >9%) or insulin use Uncontrolled hypertension (BP >150 /90 mmHg) Any severe chronic illness, low literacy, or other condition that precludes making dietary changes or completion of study activities

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: All participants will receive the intervention<br> | Other: Multicultural Health Diet<br>* The food-based components will be similar to the anti-inflammatory diet of the ongoing MHD study (NCT03240406), which emphasizes limiting animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participant. The diet will also be tailored to needs of the CKD population including a focus on lowering sodium intake. The intervention (dietary counseling) will be delivered by experienced kidney disease nutritionist.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of dietary intervention | Change in dietary inflammatory score (Dietary intake will be scored using a dietary inflammation index). The scores at baseline (pre-intervention) will be compared to scores at 2 months. A lower score indicates a more anti-inflammatory dietary pattern. The intervention will be considered feasibile if ≥65% participants have a 2-point or more reduction from their baseline dietary inflammation score. | 2 months post baseline | 
| Acceptability | This will be assessed using questionnaires and structured interviews about the dietary intervention | 2 months post baseline |