Chronic Kidney Disease
Conditions
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 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.
Interventions
OTHERMulticultural 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.
Sponsors
Montefiore Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Dietary Intervention | From baseline (pre-intervention) to 2 months (post-intervention) | Feasibility will be assessed using the Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool and the Energy-Adjusted Dietary Inflammatory Index (E-DII®). 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 (i.e., food diaries). The Energy Adjusted Dietary Inflammatory Index (E-DII®) quantifies the inflammatory potential of a person's diet while adjusting for total energy intake. Scores range from -8.87 (maximally anti-inflammatory) to +7.98 (maximally pro-inflammatory). Higher (positive) scores indicate greater adherence to a pro-inflammatory dietary pattern (e.g., highly processed or fried foods, sugary beverages) and are associated with poorer health outcomes, whereas lower (negative) scores indicate greater adherence to an anti-inflammatory dietary pattern (e.g., leafy greens, fruits, fish) and are associated with better health outcomes. |
| Acceptability of Dietary Intervention | 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; 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTanya Johns, MD
Montefiore Medical Center
Participant flow
Pre-assignment details
All 18 participants who were consented were enrolled into the study.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 65.0 years STANDARD_DEVIATION 2.84 |
| Angiotensin converting enzyme inhibitors (ACEi) and Angiotensin Receptor Blockers (ARBs) usage | 12 Participants |
| Estimated Glomerular Filtration Rate (eGFR) | 48.0 mL/min/1.73m^2 STANDARD_DEVIATION 1.64 |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 6 Participants |
| Race/Ethnicity, Customized Multiracial/Biracial | 1 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized White | 0 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 18 |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
None listed