Trial Outcomes & Findings for Multicultural Healthy Diet in Chronic Kidney Disease (NCT NCT05504850)
NCT ID: NCT05504850
Last Updated: 2026-08-11
Results Overview
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.
COMPLETED
NA
18 participants
From baseline (pre-intervention) to 2 months (post-intervention)
2026-08-11
Participant Flow
All 18 participants who were consented were enrolled into the study.
Participant milestones
| Measure |
All Participants Will Receive the Intervention
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.
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|---|---|
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Overall Study
STARTED
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18
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Overall Study
COMPLETED
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17
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
| Measure |
All Participants Will Receive the Intervention
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.
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|---|---|
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Overall Study
Protocol Violation
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1
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Baseline Characteristics
Multicultural Healthy Diet in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
All Participants Will Receive the Intervention
n=17 Participants
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.
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|---|---|
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Age, Continuous
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65.0 years
STANDARD_DEVIATION 2.84 • n=54 Participants
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Sex: Female, Male
Female
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10 Participants
n=54 Participants
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Sex: Female, Male
Male
|
7 Participants
n=54 Participants
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|
Race/Ethnicity, Customized
Black or African American
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9 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Hispanic
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6 Participants
n=54 Participants
|
|
Race/Ethnicity, Customized
Multiracial/Biracial
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1 Participants
n=54 Participants
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Race/Ethnicity, Customized
Asian
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0 Participants
n=54 Participants
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Race/Ethnicity, Customized
White
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0 Participants
n=54 Participants
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Race/Ethnicity, Customized
Other
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1 Participants
n=54 Participants
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Region of Enrollment
United States
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17 participants
n=54 Participants
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Estimated Glomerular Filtration Rate (eGFR)
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48.0 mL/min/1.73m^2
STANDARD_DEVIATION 1.64 • n=54 Participants
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Angiotensin converting enzyme inhibitors (ACEi) and Angiotensin Receptor Blockers (ARBs) usage
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12 Participants
n=54 Participants
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PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
All Participants Will Receive the Intervention
n=17 Participants
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.
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|---|---|
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Feasibility of Dietary Intervention
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-0.61 score on a scale
Interval -1.51 to 0.29
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PRIMARY outcome
Timeframe: 2 months post baselineAcceptability 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.
Outcome measures
| Measure |
All Participants Will Receive the Intervention
n=17 Participants
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.
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|---|---|
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Acceptability of Dietary Intervention
Met their approval · Completely disagree
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0 Participants
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Acceptability of Dietary Intervention
Met their approval · Disagree
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0 Participants
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Acceptability of Dietary Intervention
Met their approval · Neither agree nor disagree
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4 Participants
|
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Acceptability of Dietary Intervention
Met their approval · Agree
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6 Participants
|
|
Acceptability of Dietary Intervention
Met their approval · Completely agree
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7 Participants
|
|
Acceptability of Dietary Intervention
Was appealing · Completely disagree
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0 Participants
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Acceptability of Dietary Intervention
Was appealing · Disagree
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0 Participants
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Acceptability of Dietary Intervention
Was appealing · Neither agree nor disagree
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4 Participants
|
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Acceptability of Dietary Intervention
Was appealing · Agree
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11 Participants
|
|
Acceptability of Dietary Intervention
Was appealing · Completely agree
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2 Participants
|
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Acceptability of Dietary Intervention
Whether they liked the diet, in general · Completely disagree
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0 Participants
|
|
Acceptability of Dietary Intervention
Whether they liked the diet, in general · Disagree
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0 Participants
|
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Acceptability of Dietary Intervention
Whether they liked the diet, in general · Neither agree nor disagree
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0 Participants
|
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Acceptability of Dietary Intervention
Whether they liked the diet, in general · Agree
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11 Participants
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Acceptability of Dietary Intervention
Whether they liked the diet, in general · Completely agree
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6 Participants
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Acceptability of Dietary Intervention
Liked using herbs/spices that they had not used before · Completely disagree
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0 Participants
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Acceptability of Dietary Intervention
Liked using herbs/spices that they had not used before · Disagree
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1 Participants
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Acceptability of Dietary Intervention
Liked using herbs/spices that they had not used before · Neither agree nor disagree
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6 Participants
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Acceptability of Dietary Intervention
Liked using herbs/spices that they had not used before · Agree
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8 Participants
|
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Acceptability of Dietary Intervention
Liked using herbs/spices that they had not used before · Completely agree
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2 Participants
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Acceptability of Dietary Intervention
Would recommend the diet to family/friends · Completely disagree
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0 Participants
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Acceptability of Dietary Intervention
Would recommend the diet to family/friends · Disagree
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0 Participants
|
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Acceptability of Dietary Intervention
Would recommend the diet to family/friends · Neither agree nor disagree
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0 Participants
|
|
Acceptability of Dietary Intervention
Would recommend the diet to family/friends · Agree
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12 Participants
|
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Acceptability of Dietary Intervention
Would recommend the diet to family/friends · Completely agree
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5 Participants
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OTHER_PRE_SPECIFIED outcome
Timeframe: 2-4 weeks after first session with nutritionist (onset of intervention)A serum potassium will be assessed 2-4 weeks after starting the diet as an added safety measure. Results are summarized in milliequivalents/liter (mEq/L).
Outcome measures
| Measure |
All Participants Will Receive the Intervention
n=17 Participants
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.
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|---|---|
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Potassium Level
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4.12 mEq/L
Standard Deviation 0.13
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Adverse Events
All Participants Will Receive the Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place