Multicultural Healthy Diet in Chronic Kidney Disease
Primary Purpose
Chronic Kidney Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multicultural Health Diet
Sponsored by
About this trial
This is an interventional other trial for Chronic Kidney Disease
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 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
Sites / Locations
- Montefiore Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
All participants will receive the intervention
Arm Description
Outcomes
Primary Outcome Measures
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.
Acceptability
This will be assessed using questionnaires and structured interviews about the dietary intervention
Secondary Outcome Measures
Full Information
NCT ID
NCT05504850
First Posted
August 15, 2022
Last Updated
September 26, 2023
Sponsor
Montefiore Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT05504850
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
All participants will receive the intervention
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Multicultural Health Diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of dietary intervention
Description
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.
Time Frame
2 months post baseline
Title
Acceptability
Description
This will be assessed using questionnaires and structured interviews about the dietary intervention
Time Frame
2 months post baseline
Other Pre-specified Outcome Measures:
Title
Potassium level
Description
A serum potassium will be assessed 2 weeks after starting the diet as an added safety measure.
Time Frame
2 weeks after first session with nutritionist
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tanya Johns, MD
Phone
718-430-3301
Email
tjohns@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Lisandra Villalba
Phone
718-430-3301
Email
lisandra.ninonuevo@einsteinmed.edu
Facility Information:
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisandra Villaba, MD
Phone
718-430-3301
Email
lisandra.ninonuevo@einsteinmed.edu
12. IPD Sharing Statement
Learn more about this trial
Multicultural Healthy Diet in Chronic Kidney Disease
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