Plain English Summary
Background and study aims
Phosphorus is an essential mineral that is required by every cell in the body for normal function, but high phosphorus levels can lead to cardiovascular (heart) disease. Shift workers have an increased risk of coronary heart disease, suggesting that eating at night may affect how the body uses phosphorus (phosphorus metabolism), but this has not been investigated. The purpose of this study was to investigate the effects of nocturnal eating on phosphorus metabolism.
Who can participate?
Healthy men aged 20-40.
What does the study involve?
Participants were served test meals three times a day (breakfast at 07:30, lunch at 12:30, dinner at either 17:30 or 22:30). Blood and urine samples were collected to assess phosphorus levels until the following morning.
What are the possible benefits and risks of participating?
Participants will find out their health status. There is a risk of side effects from the blood sample collection.
Where is the study run from?
University of Shizuoka (Japan).
When is the study starting and how long is it expected to run for?
July 2013 to January 2015.
Who is funding the study?
Ministry of Education, Culture, Sports, Science and Technology (Japan).
Who is the main contact?
Dr Masae Sakuma
sakuma@u-shizuoka-ken.ac.jp
Trial website
Contact information
Type
Scientific
Primary contact
Dr Masae Sakuma
ORCID ID
Contact details
52-1
Yada
Suruga-ku
Shizuoka
422-8526
Japan
+81 (0)54 264 5596
sakuma@u-shizuoka-ken.ac.jp
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
University hospital Medical Information Network (UMIN)/UMIN000014380
Study information
Scientific title
Effect of nocturnal eating on phosphorus excretion in young subjects: a randomized crossover trial
Acronym
Study hypothesis
To assess the effects of nocturnal eating on phosphorus metabolism.
Ethics approval
The Ethics Committee of the University of Shizuoka, 25/06/2013, ref: University of Shizuoka 25-9
Study design
interventional randomized crossover trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Condition
Hyperphosphatemia
Intervention
The subjects were served test meals three times a day (breakfast 07:30 h, lunch 12:30 h, dinner 17:30 or 22:30 h). Blood and urine samples were collected to assess diurnal variation until the following morning.
Intervention type
Other
Phase
Drug names
Primary outcome measures
Serum phosphorus level, measured at baseline (0 hours) and 2.5, 5.0, 7.5, 10.0, 12.5, 15.0, 24.0 hours after
Secondary outcome measures
1. Urinary phosphorus excretion, measured at four times over the 24 hours: between 07:30 h to 12:30 h (morning); 12:30 h to 17:30 h (afternoon); 17:30 h to 22:30 h (evening); and 22:30 h to 07:30 h, the following morning (night)
2. Serum parathyroid hormone level, measured at baseline (0 hours) and 2.5, 5.0, 7.5, 10.0, 12.5, 15.0, 24.0 hours after
3. Serum FGF23 level, measured at baseline (0 hours) and 2.5, 5.0, 7.5, 10.0, 12.5, 15.0, 24.0 hours after
Overall trial start date
13/07/2013
Overall trial end date
08/01/2015
Reason abandoned
Eligibility
Participant inclusion criteria
1. 20-40 years old
2. Male
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
14
Participant exclusion criteria
1. Smoking
2. History or medication use for glucose tolerance, renal or hepatic dysfunction
Recruitment start date
13/07/2013
Recruitment end date
31/10/2014
Locations
Countries of recruitment
Japan
Trial participating centre
University of Shizuoka
422-8526
Japan
Funders
Funder type
Government
Funder name
Ministry of Education, Culture, Sports, Science and Technology (Japan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
To be confirmed at a later date
Intention to publish date
Participant level data
Available on request
Results - basic reporting
Publication summary
2015 results in http://www.ncbi.nlm.nih.gov/pubmed/26450680