the Regulation of Phosphorus Homeostasis by Dietary Phosphorus Intake in Normal Men

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: normal diet; Other: low-phosphorus diet; Other: high-phosphorus diet

• Registration Number: NCT03208075
• Lead Sponsor: Huashan Hospital

Brief Summary

The investigators have conducted the study about the effects of normal diet and low-phosphorus diet on phosphorus homeostasis in healthy subjects, now this study is designed to explore further about the effect of high-phosphorus diet on phosphorus homeostasis.

Detailed Description

Serum phosphate concentrations are not only associated with cardiovascular and all-cause mortality in chronic kidney disease (CKD) patients, but also associated with the mortality in community population. Thus, maintaining normal serum phosphate and reducing postprandial fluctuation of serum phosphate are essential for healthy people.

The investigators have conducted a study about the effects of normal diet (phosphorus 1500mg) and low-phosphorus diet (phosphorus 500mg) on phosphorus homeostasis in healthy men. The results showed low-phosphorus diet could significantly reduce serum phosphorus and urine phosphorus level compared to normal diet. However, the levels of serum FGF23 and a-klotho were not different between these two groups.Thus, the investigators want to further explore the effects of high-phosphorus diet (phosphorus 2300mg)on phosphorus homeostasis in healthy men.

Therefore, the investigators plan to conduct a crossover clinical study to evaluate the phosphorus homeostasis modulated by native normal diet, restricted phosphorus diet, high phosphorus diet and then to explore the underlying mechanisms.

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2017-07-02
• Study First Submitted QC: 2017-07-02
• Study First Posted: 2017-07-05
• Status Verified: 2017-08
• Primary Completion: 2017-08-01
• Study Completion: 2017-08-01
• Last Update Submitted: 2017-08-11
• Last Update Posted: 2017-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 6

Inclusion Criteria

• Men aged 18-45 years
• Healthy volunteers: no history of chronic diseases; no active symptoms or physical signs; negative results of electrocardiogram and chest X-ray; biochemical indicators of regular medical examination are within 95%-105% of normal range.
• Willingness to sign the consent form approved by an Institutional Review Board and comply with the study protocol.
• Body mass index ranged within 18.5-24 kg/m2.

Exclusion Criteria

• Current history of drug or alcohol abuse as assessed by the principal Investigator.
• Subject has blood donations or blood loss more than 300ml within three months
• Allergic to more than two foods or drugs.
• Subject has psycho-disability or body disability.
• Subject has a condition that in the judgment of the Principal Investigator could potentially pose a health risk to the patient while involved in the study.
• Subject has participated in the other clinical trials at the same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal Phosphorus Diet	normal diet	Diet containing 1500mg of phosphorus per day
Low-phosphorus Diet	low-phosphorus diet	Diet containing 500mg of phosphorus per day
High-phosphorus Die	high-phosphorus diet	Diet containing 2300mg of phosphorus per day

Primary Outcome Measures

Name	Time	Method
Circadian rhythm of serum phosphorus concentration	24 hour

Secondary Outcome Measures

Name	Time	Method
Circadian rhythm of urine phosphorus concentration	24 hour
Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)	24 hour
Circadian rhythm of parathyroid hormone (PTH)	24 hour
Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)	24 hour

Trial Locations

Locations (1)

Huashan hospital, Shanghai Medical College, Fudan University; 🇨🇳 Shanghai, Shanghai, China