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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: normal diet; Other: low-phosphorus diet; Other: high-phosphorus diet

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Huashan hospital, Shanghai Medical College, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal Phosphorus Diet; Diet containing 1500mg of phosphorus per day	Other: normal diet; Diet containing 1500mg of phosphorus
Experimental: Low-phosphorus Diet; Diet containing 500mg of phosphorus per day	Other: low-phosphorus diet; Diet containing 500mg of phosphorus
Experimental: High-phosphorus Die; Diet containing 2300mg of phosphorus per day	Other: high-phosphorus diet; Diet containing 2300mg of phosphorus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Circadian rhythm of serum phosphorus concentration	24 hour

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Huashan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2017
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: July 2, 2017
• First Submitted That Met QC Criteria: July 2, 2017
• First Posted (Actual): July 5, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2017
• Last Update Submitted That Met QC Criteria: August 11, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: phosphorus; healthy subject; phosphorus,diet
• Other Study ID Numbers: HuashanH-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No