Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
18 participants
Study Classification
INTERVENTIONAL
Study Start Date
2022-11-03
Study Completion Date
2024-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Chronic Kidney Disease
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
OTHER
Blinding Strategy
NONE
Study Groups
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All participants will receive the intervention
Group Type
OTHER
Multicultural Health Diet
Intervention Type
OTHER
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.
Interventions
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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.
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Sponsor Role
collaborator
Montefiore Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Tanya Johns, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center
Locations
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Montefiore Medical Center
The Bronx, New York, United States
Site Status
Countries
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United States
References
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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2021-12753
Identifier Type: -
Identifier Source: org_study_id
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