Multicultural Healthy Diet in Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05504850
• Other study ID #: 2021-12753
• Secondary ID: K23DK124644
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2022
• Est. completion date: October 2024

Study information

• Verified date: May 2024
• Source: Montefiore Medical Center
• Contact: Tanya Johns, MD
• Phone: 718-430-3301
• Email: tjohns[@]montefiore.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

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.

Locations

Country	Name	City	State
United States	Montefiore Medical Center	Bronx	New York

Sponsors (2)

Lead Sponsor	Collaborator
Montefiore Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	Acceptability	This will be assessed using questionnaires and structured interviews about the dietary intervention	2 months post baseline