- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07829991
Development of a Precision Nutrition Expert System Combining AI Dietary Image Recognition and Big Data Analysis: A Case Study on Kidney Disease (CKDCare)
The goal of this interventional study is to evaluate a smartphone-based precision nutrition system for patients with chronic kidney disease (CKD).
The main questions it aims to answer are:
- Do patients with CKD find the CKDCare system easy to use?
- Does using the system change patients' dietary intake, including the proportion of ultra-processed foods they consume?
The system, called CKDCare, runs inside the LINE messaging app. It uses artificial intelligence to recognize food from photos, a chatbot to answer everyday diet questions, and a back-end dashboard that lets dietitians review each person's dietary records.
Participants will:
- Use the CKDCare system in the LINE app for three months
- Take photos of their meals and record what they eat
- Complete a questionnaire about how easy the system is to use
Have their routine clinic blood test results and nutritional assessment reviewed as part of their usual care.
Some participants will also take part in a short interview about their experience. Dietitians and physicians who care for CKD patients will use the back-end management system and give feedback on it.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
CKD patients:
- Aged 20 years or older
- Physician-diagnosed chronic kidney disease
- Available dietary records from the outpatient nutrition clinic
Healthcare professionals:
- Clinical dietitian certified in CKD nutrition, CKD outpatient dietitian, or nephrologist
Exclusion Criteria:
- Younger than 20 years of age
- No available dietary records from the outpatient nutrition clinic
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: CKD patients
Adults aged 20 years or older with a physician-diagnosed chronic kidney disease, recruited from the outpatient nutrition clinic. Participants used the CKDCare LINE chatbot to record their meals and receive personalized dietary advice for three months. |
Participants will use the CKDCare system, a dietitian-led LINE chatbot integrating dietary self-monitoring, personalized nutrition feedback, and nutrition education for CKD self-management. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
System Usability Scale (SUS) score
Time Frame: At 3 months (end of the system trial period)
|
Usability of the CKDCare system measured by the 10-item System Usability Scale. Total score ranges from 0 to 100, with higher scores indicating better perceived usability. |
At 3 months (end of the system trial period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Estimated glomerular filtration rate (eGFR)
Time Frame: Baseline and after the intervention (at 3 months)
|
Estimated glomerular filtration rate (eGFR) will be obtained from routine clinical laboratory records and expressed in mL/min/1.73 m². Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Blood urea nitrogen (BUN)
Time Frame: Baseline and after the intervention (at 3 months)
|
Blood urea nitrogen (BUN) will be obtained from routine clinical laboratory records and expressed in mg/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum creatinine
Time Frame: Baseline and after the intervention (at 3 months)
|
Serum creatinine will be obtained from routine clinical laboratory records and expressed in mg/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum albumin
Time Frame: Baseline and after the intervention (at 3 months)
|
Serum albumin will be obtained from routine clinical laboratory records and expressed in g/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum potassium
Time Frame: Baseline and after the intervention (at 3 months)
|
Serum potassium will be obtained from routine clinical laboratory records and expressed in mmol/L. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Serum phosphorus
Time Frame: Baseline and after the intervention (at 3 months)
|
Serum phosphorus will be obtained from routine clinical laboratory records and expressed in mg/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Hemoglobin (Hb)
Time Frame: Baseline and after the intervention (at 3 months)
|
Hemoglobin will be obtained from routine clinical laboratory records and expressed in g/dL. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily energy intake
Time Frame: Baseline and after the intervention (at 3 months)
|
Daily energy intake will be assessed using dietary records and expressed in kilocalories per day (kcal/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily protein intake
Time Frame: Baseline and after the intervention (at 3 months)
|
Daily protein intake will be assessed using dietary records and expressed in grams per day (g/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily sodium intake
Time Frame: Baseline and after the intervention (at 3 months)
|
Daily sodium intake will be assessed using dietary records and expressed in milligrams per day (mg/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily potassium intake
Time Frame: Baseline and after the intervention (at 3 months)
|
Daily potassium intake will be assessed using dietary records and expressed in milligrams per day (mg/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Daily phosphorus intake
Time Frame: Baseline and after the intervention (at 3 months)
|
Daily phosphorus intake will be assessed using dietary records and expressed in milligrams per day (mg/day). Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Subjective Global Assessment (SGA)
Time Frame: Baseline and after the intervention (at 3 months)
|
Nutritional status will be assessed by a dietitian using the Subjective Global Assessment (SGA), classified as well nourished (A), moderately malnourished (B), or severely malnourished (C). Changes in nutritional status from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
|
Proportion of ultra-processed food intake
Time Frame: Baseline and after the intervention (at 3 months)
|
The proportion of ultra-processed food intake will be assessed using the NOVA food classification system. Kidney disease-specific therapeutic nutritional supplements will be excluded from the calculation. Changes from baseline to 3 months will be evaluated. |
Baseline and after the intervention (at 3 months)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- CMUH114-REC1-021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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