The proposed pilot feeding study aims to explore novel pathways in phosphate metabolism and identify new biomarkers, as well as to develop a compound index for assessing phosphate overload with high validity and reliability. Investigators will address the following specific aims: 1). To explore novel pathways of phosphate metabolism and assess the influence of CKD status on these metabolic pathways. 2). To identify novel biomarkers for phosphate overload that reflect changes in dietary phosphorus intake. 3). To develop a compound phosphate overload index that measures dietary phosphorus intake with high validity and reliability. This study will provide novel insights into phosphate metabolism and the assessment of phosphate overload in CKD patients. This investigation aims to provide preliminary data to further studies for the development of reliable biomarkers in CKD patients, which could contribute significantly to early interventions and improve health outcomes.
Specifically, study team propose recruiting 30 participants with CKD and 30 without CKD to investigate the responses of blood metabolites and known biomarkers to a 21-day diet intervention. The intervention will consist of a dietary phosphorus intake of about 777 mg/day for 7 days, followed by an increase to about 1,277mg/day for another 7 days, and a further increase to about 1,777 mg/day for the subsequent 7 days. 1200 mg/day and 1700 mg/day phosphorus diets will be achieved by providing participants with sodium phosphate capsules and 777 mg/day meals. The meal plan will maintain consistent intake of calories, sodium, potassium, and calcium throughout the 21-day intervention. Sodium, calcium, and potassium content will not change significantly throughout the intervention. The overnight fasting blood and 24-hour and random urine samples will be collected at the baseline and end of each phase.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
60
Dietary phosphorus intake of about 777 mg/day for 7 days, followed by an increase to about 1,277mg/day for another 7 days, and a further increase to about 1,777 mg/day for the subsequent 7 days. The meal plan will maintain consistent intake of calories, sodium, potassium, and calcium throughout the 21-day intervention. 1200 mg/day and 1700 mg/day phosphorus diets will be achieved by providing participants with sodium phosphate capsules and 777 mg/day meals.
University of Texas Southwestern Medical Center
Dallas, Texas, United States
RECRUITINGChange in serum phosphate levels
Circulating serum phosphate levels (mg/dL) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Change in parathyroid hormone (PTH) levels
Circulating PTH levels (pg/mL) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Change in C-terminal Fibroblast Growth Factor 23 (FGF23) levels
Circulating C-terminal FGF23 levels (RU/mL) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Change in Fibroblast Growth Factor 23 (FGF23) levels
Circulating FGF23 levels (pg/mL) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Phosphate burden indices
Phosphate burden indices, developed using machine learning methods to systematically incorporate both known biomarkers and novel biomarkers. No units have been identified, we anticipate creating a score.
Time frame: Baseline, week 1, week 2, week 3
Change in serum calcium levels
Circulating serum calcium levels (mg/dL) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Change in Alkaline Phosphatase (ALP) levels
Circulating serum ALP levels (U/L) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Change in 1,25-dihydroxyvitamin D levels
Circulating serum 1,25-dihydroxyvitamin D levels (pg/mL) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Change in Bone-Specific Alkaline Phosphatase (BALP) levels
Circulating serum BALP levels (U/L) will be measured using standard clinical laboratory assays
Time frame: Baseline, week 1, week 2, and week 3
Change in urinary calcium levels
Circulating urinary calcium excretion levels (mg/day) will be measured using standardized laboratory urine assays
Time frame: Baseline, week 1, week 2, and week 3
Change in urinary phosphorus levels
Circulating urinary phosphorus excretion levels (mg/day) will be measured using standardized laboratory urine assays
Time frame: Baseline, week 1, week 2, and week 3
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