the Effects of Different Dietary Phosphorus Intake on the Circadian Pattern of Serum Phosphate in Normal Subjects

NCT02636153 | Completed DMC

• 1 other identifier: HuashanH
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of normal diet and low-phosphate diet on the level and the circadian pattern of serum phosphate concentration in normal subjects and to explore the underlying mechanisms.

Conditions

Healthy

Keywords

phosphorus,dietary; circadian rhythm; phosphorus

Outcome Measures

Primary Outcomes (1)

• Circadian rhythm of serum phosphorus concentration

  24 hour

Secondary Outcomes (4)

• 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

• Circadian rhythm of matrix extracellular phosphoglycoprotein (MEPE)

  24 hour

Study Arms (2)

Normal Phosphorus Diet

EXPERIMENTAL

Diet containing 1500mg of phosphorus per day

Other: normal diet

Restricted Phosphorus Diet

EXPERIMENTAL

Diet containing 500mg of phosphorus per day

Other: restricted phosphate diet

Interventions

normal diet OTHER

Diet containing 1500mg of phosphorus

Normal Phosphorus Diet

restricted phosphate diet OTHER

Diet containing 500mg of phosphorus

Restricted Phosphorus Diet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan hospital, Shanghai Medical College, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2015
• First Posted: December 21, 2015
• Study Start: May 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: August 17, 2016

Record last verified: 2016-08

Locations

CN (1)