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Completed

NCT Number: NCT03208075

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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Huashan hospital, Shanghai Medical College, Fudan University

Shanghai, Shanghai Municipality, 200040, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Normal Diet

Other

Diet containing 1500mg of phosphorus

low-phosphorus diet

Other

Diet containing 500mg of phosphorus

high-phosphorus diet

Other

Diet containing 2300mg of phosphorus

Primary outcomes

  1. Circadian rhythm of serum phosphorus concentration

    Time frame: 24 hour

Secondary outcomes

  1. Circadian rhythm of urine phosphorus concentration

    Time frame: 24 hour

  2. Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)

    Time frame: 24 hour

  3. Circadian rhythm of parathyroid hormone (PTH)

    Time frame: 24 hour

  4. Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)

    Time frame: 24 hour

Sponsors and collaborators

Lead sponsor

Huashan Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 5, 2017
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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