Studies on the effect of dietary phosphorus loading on the physiological function and determination of tolerable upper intake level of phosphorus in human.

UMIN ID: UMIN000000803

Registered date:31/08/2007

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Chronic Kidney Disease, Cardiovascular disease, metabolic bone disease
• Date of first enrollment: 2008/07/01
• Target sample size: 30
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

high phosphorus diet (Phosphorus 1200mg/meal, bolus) -> wash out period (al least 1day) -> control phosphorus diet (Phosphorus 400mg/meal, bolus)
control phosphorus diet (Phosphorus 400mg/meal, bolus) -> wash out period (al least 1day) -> high phosphorus diet (Phosphorus 1200mg/meal, bolus)
high phosphorus diet (Phosphorus 800mg/meal, bolus) -> wash out period (al least 1day) -> control phosphorus diet (Phosphorus 400mg/meal, bolus)

Outcome(s)

• Primary Outcome: Serum P, serum Ca, intact PTH, intact FGF23, urinary P, urinary Ca, Flow-mediated dilation (FMD) before and after the meal ingestion (until 8h later).
• Secondary Outcome: Serum TG, serum glucose, serum creatinine, urinary creatinine before and after the meal ingestion (until 8h later).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 40years-old
• Gender: Male and Female
• Exclude criteria: hyperlipidemia, hypertension, kidney dysfunction, diabetes, cardiovascular disease

Related Information

• Primary Sponsor: Department of Clinical Nutrition, Institute of Health Biosciences, University of Tokushima
• Source(s) of Monetary Support: Ministry of Education, Culture, Sports Science, and Technology of Japan,Ministry of Agriculture, Forestry and Fisheries of Japan The Kidney Foundation, Japan