Multicultural Healthy Diet in Chronic Kidney Disease

Montefiore Medicine Academic Health System

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: Multicultural Health Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05504850

K23DK124644-01A1 (U.S. NIH Grant/Contract)

2021-12753

Details and patient eligibility

About

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.

Full 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 approximately 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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥18 years
• CKD stage 3 (estimated glomerular filtration rate (eGFR) ≥ 30 ml/min/1.73m^2 to < 60 ml/min/1.73m^2)
• Residency in the Bronx
• Sufficient hearing, vision, and proficiency in English or Spanish to comprehend dietary counseling and low-level printed educational materials
• Provide written informed consent

Exclusion criteria

• History of hyperkalemia, or baseline serum potassium (K) > 4.8
• CKD stage 4 or higher estimated Glomerular Filtration Rate (eGFR) <30 ml/min/1.73 m^2
• Unwillingness/inability to make dietary changes or if primarily interested in weight loss as judged by discussion with the participant
• History of kidney transplant
• Poorly controlled diabetes (HbA1c >9%) or insulin use
• Any severe chronic illness, low literacy, or other serious condition that precludes making dietary changes and requires strict dietary restrictions or completion of study activities
• Plans to relocate out of New York City in the next 2 months
• Visual, auditory, or motor impairment that precludes completion of the assessments

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

18 participants in 1 patient group

All participants will receive the intervention

Other group

Treatment:

Other: Multicultural Health Diet