Multicultural Healthy Diet in Chronic Kidney Disease

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: Multicultural Health Diet

• Registration Number: NCT05504850
• Lead Sponsor: Montefiore Medical Center

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-08-15
• Study First Submitted QC: 2022-08-15
• Study First Posted: 2022-08-17
• Study Start: 2022-11-03
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 potassium (K) > 4.8
• CKD stage 4 or higher (eGFR <30 ml/min/1.73 m^2)
• Unwillingness to make dietary changes
• History of kidney transplant
• Poorly controlled diabetes (HbA1c >9%) or insulin use
• Any severe chronic illness, low literacy, or other condition that precludes making dietary changes or completion of study activities

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants will receive the intervention	Multicultural Health Diet	-

Primary Outcome Measures

Name	Time	Method
Acceptability	2 months post baseline	This will be assessed using questionnaires and structured interviews about the dietary intervention
Feasibility of dietary intervention	2 months post baseline	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.

Trial Locations

Locations (1)

Montefiore Medical Center; 🇺🇸 Bronx, New York, United States