Clinical trial NCT05504850: Multicultural Healthy Diet in Chronic Kidney Disease
Official title: The Feasibility and Acceptability of a Multicultural Healthy Diet (Anti-inflammatory Dietary Pattern) in Racial/Ethnic Minorities With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2022-08-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of dietary intervention
timeFrame: 2 months post baseline
measure: Acceptability
timeFrame: 2 months post baseline
Secondary outcomes:
Other outcomes:
measure: Potassium level
timeFrame: 2 weeks after first session with nutritionist
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Tanya Johns, MD
role: PRINCIPAL_INVESTIGATOR
References:
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