Multicultural Healthy Diet in Chronic Kidney Disease

December 30, 2025 updated by: Montefiore Medical Center

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

Completed

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From baseline to 2 months post baseline
Feasibility of the dietary intervention will be assessed using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index Diet (E-DII®) platform. The ASA24® is a web-based tool that enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries. The EE-DII® is a scientific tool that quantifies the potential of a person's diet to cause inflammation, adjusting for total calorie intake for better accuracy. It assigns higher (positive) scores to pro-inflammatory diets (processed meats, sugary drinks) and lower (negative) scores to anti-inflammatory diets (leafy greens, fruits, fish). For this study scores at baseline (pre-intervention) will be compared to scores at 2 months using the E-DII®. The intervention will be considered feasible if ≥ 65% participants have a 2-point or more reduction from their baseline dietary inflammation score.
From baseline to 2 months post baseline
Acceptability of dietary intervention
Time Frame: 2 months post baseline
Acceptability of the dietary intervention will be assessed using the Acceptability of the Multicultural Healthy Diet (MHD) in CKD questionnaire. Participants will be asked to rate acceptability based on five items regarding whether the dietary intervention met their approval; was appealing, whether they liked the diet, in general, and liked using herbs/spices that they had not used before; and would recommend the diet to family/friends. Responses to each item are rated on a 5-point ordinal scale: (Completely disagree, Disagree, Neither agree nor disagree, Agree or Completely agree). The number/percentage of participants selecting each category will be tabulated.
2 months post baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potassium level
Time Frame: 2 weeks after first session with nutritionist
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

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Tanya Johns, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2022

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 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 (Estimated)

January 12, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-12753
  • K23DK124644-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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