Multicultural Healthy Diet in Chronic Kidney Disease

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Other: Multicultural Health Diet

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tanya Johns, MD; Phone Number: 718-430-3301; Email: tjohns@montefiore.org
• Study Contact Backup: Name: Lisandra Villalba; Phone Number: 718-430-3301; Email: lisandra.ninonuevo@einsteinmed.edu

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10461
      • Recruiting
      • Montefiore Medical Center
      • Contact: Lisandra Villaba, MD; Phone Number: 718-430-3301; Email: lisandra.ninonuevo@einsteinmed.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: All participants will receive the intervention

Other: Multicultural Health Diet; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Potassium level	A serum potassium will be assessed 2 weeks after starting the diet as an added safety measure.	2 weeks after first session with nutritionist

Collaborators and Investigators

• Sponsor: Montefiore Medical Center
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2022
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: August 15, 2022
• First Submitted That Met QC Criteria: August 15, 2022
• First Posted (Actual): August 17, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Renal Insufficiency; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: 2021-12753; K23DK124644 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No