HealthyNCT02636153
the Effects of Different Dietary Phosphorus Intake on the Circadian Pattern of Serum Phosphate in Normal Subjects
A study testing normal diet and restricted phosphate diet in people with Healthy, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- normal diet and restricted phosphate diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan hospital, Shanghai Medical College, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
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.
Read the detailed description
Emerging evidence show that 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 (without history of CKD or cardiovascular disease). The rise of serum phosphate will lead to the elevation of serum plasma fibroblast growth factor 23 (FGF23) and parathyroid hormone (PTH) in healthy people, contributing to bone disorders and left ventricle thickening. Therefore, maintaining normal serum phosphate and reducing postprandial fluctuation of serum phosphate are essential for CKD patients as well as healthy people.
As for serum phosphate modulation by diet, most evidence was focused on CKD patients, less focused on healthy people. An American study in 1980s indicated that phosphorus intake was significantly related with the level of 24-h serum phosphate and the circadian pattern of serum phosphate. However, this study failed to explore the underlying mechanisms and the diet in America is different from that in China. Nowadays, normal diet in China is inclined to having more calories and protein, which warrants high diet phosphorus intake, may contributing to huge fluctuation of serum phosphate and thus elevating the incidence and mortality of cardiovascular disease. Therefore, what is the level and circadian pattern of serum phosphate concentrations in normal subjects under our native normal diet in China? Is restricted phosphate diet able to alter the level and circadian pattern of serum phosphate? These questions are what the investigator sare eager to answer.
Accumulating evidence suggest that gastrointestinal tract has a vital effect in phosphate modulation. Berndt etc. suggested that in rat, epidermal cells of duodenum and jejunum could sense the gastrointestinal tract phosphate load, rapidly activating the type IIa Na/Pi-cotransporter in the renal tubule cells, leading to the increase of urinary phosphate, without any changes of serum FGF23, PTH and phosphate concentrations. So the author proposed that there had a gastro intestine-kidney axis in phosphate modulation. However, whether this axis exists in human body remains unclear.
Therefore, the investigators plan to conduct a crossover clinical study to evaluate the level and circadian pattern of serum phosphate concentrations modulated by native normal diet and restricted phosphate diet and then to explore the underlying mechanisms.
- Conditions
- Healthy
- Being tested
- normal diet, restricted phosphate diet
- Keywords
- phosphorus,dietary, circadian rhythm, phosphorus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal dietOther
Diet containing 1500mg of phosphorus
restricted phosphate dietOther
Diet containing 500mg of phosphorus
| Study group | Role | What they receive |
|---|---|---|
| Normal Phosphorus Diet | Experimental | Diet containing 1500mg of phosphorus per day Receives: Other: normal diet |
| Restricted Phosphorus Diet | Experimental | Diet containing 500mg of phosphorus per day Receives: Other: restricted phosphate diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian rhythm of serum phosphorus concentration
Measured: 24 hour
Secondary outcomes (4)
Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)
Measured: 24 hour
Circadian rhythm of parathyroid hormone (PTH)
Measured: 24 hour
Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)
Measured: 24 hour
Circadian rhythm of matrix extracellular phosphoglycoprotein (MEPE)
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startMay 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Jing, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636153
- Sponsor's protocol ID
- HuashanH
- Status last verified
- Aug 2016
- First submitted
- 9 Dec 2015
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Effects of Different Dietary Phosphorus Intake on the Circadian Pattern of Serum Phosphate in Normal Subjects
- ClinicalTrials.gov ID
- NCT02636153
- Acronym / sponsor ID
- HuashanH
- Conditions
- Healthy
- Keywords
- phosphorus,dietary, circadian rhythm, phosphorus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Emerging evidence show that 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 (without history of CKD or cardiovascular disease). The rise of serum phosphate will lead to the elevation of serum plasma fibroblast growth factor 23 (FGF23) and parathyroid hormone (PTH) in healthy people, contributing to bone disorders and left ventricle thickening. Therefore, maintaining normal serum phosphate and reducing postprandial fluctuation of serum phosphate are essential for CKD patients as well as healthy people.
As for serum phosphate modulation by diet, most evidence was focused on CKD patients, less focused on healthy people. An American study in 1980s indicated that phosphorus intake was significantly related with the level of 24-h serum phosphate and the circadian pattern of serum phosphate. However, this study failed to explore the underlying mechanisms and the diet in America is different from that in China. Nowadays, normal diet in China is inclined to having more calories and protein, which warrants high diet phosphorus intake, may contributing to huge fluctuation of serum phosphate and thus elevating the incidence and mortality of cardiovascular disease. Therefore, what is the level and circadian pattern of serum phosphate concentrations in normal subjects under our native normal diet in China? Is restricted phosphate diet able to alter the level and circadian pattern of serum phosphate? These questions are what the investigator sare eager to answer.
Accumulating evidence suggest that gastrointestinal tract has a vital effect in phosphate modulation. Berndt etc. suggested that in rat, epidermal cells of duodenum and jejunum could sense the gastrointestinal tract phosphate load, rapidly activating the type IIa Na/Pi-cotransporter in the renal tubule cells, leading to the increase of urinary phosphate, without any changes of serum FGF23, PTH and phosphate concentrations. So the author proposed that there had a gastro intestine-kidney axis in phosphate modulation. However, whether this axis exists in human body remains unclear.
Therefore, the investigators plan to conduct a crossover clinical study to evaluate the level and circadian pattern of serum phosphate concentrations modulated by native normal diet and restricted phosphate diet and then to explore the underlying mechanisms.
Study design
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Phosphorus Diet | Experimental | Other: normal dietDiet containing 1500mg of phosphorus per day |
| Restricted Phosphorus Diet | Experimental | Other: restricted phosphate dietDiet containing 500mg of phosphorus per day |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| normal dietDiet containing 1500mg of phosphorus | Other | Normal Phosphorus Diet |
| restricted phosphate dietDiet containing 500mg of phosphorus | Other | Restricted Phosphorus Diet |
Primary outcome
Circadian rhythm of serum phosphorus concentration
Time frame: 24 hour
4 secondary outcomes
Circadian rhythm of plasma fibroblast growth factor 23 (FGF23)
Time frame: 24 hour
Circadian rhythm of parathyroid hormone (PTH)
Time frame: 24 hour
Circadian rhythm of 1, 25-dihydroxyvitamin D (1,25(OH)2D3)
Time frame: 24 hour
Circadian rhythm of matrix extracellular phosphoglycoprotein (MEPE)
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal diet and restricted phosphate diet in people with Healthy, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian rhythm of serum phosphorus concentration (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2016.