A study of effective dietary therapy to control of hyperphosphatemia
| ISRCTN | ISRCTN13160049 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13160049 |
| Protocol serial number | University hospital Medical Information Network (UMIN)/UMIN000014380 |
| Sponsor | University of Shizuoka (Japan) |
| Funder | Ministry of Education, Culture, Sports, Science and Technology (Japan) |
- Submission date
- 14/07/2015
- Registration date
- 06/10/2015
- Last edited
- 04/11/2015
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
52-1, Yada, Suruga-ku
Shizuoka
422-8526
Japan
| Phone | +81 (0)54 264 5596 |
|---|---|
| sakuma@u-shizuoka-ken.ac.jp |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | interventional randomized crossover trial |
| Secondary study design | Randomised cross over trial |
| Scientific title | Effect of nocturnal eating on phosphorus excretion in young subjects: a randomized crossover trial |
| Study objectives | To assess the effects of nocturnal eating on phosphorus metabolism. |
| Ethics approval(s) | The Ethics Committee of the University of Shizuoka, 25/06/2013, ref: University of Shizuoka 25-9 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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 |
| Key secondary outcome measure(s) |
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) |
| Completion date | 08/01/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target sample size at registration | 14 |
| Key inclusion criteria | 1. 20-40 years old 2. Male |
| Key exclusion criteria | 1. Smoking 2. History or medication use for glucose tolerance, renal or hepatic dysfunction |
| Date of first enrolment | 13/07/2013 |
| Date of final enrolment | 31/10/2014 |
Locations
Countries of recruitment
- Japan
Study participating centre
Japan
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 08/10/2015 | Yes | No |
Editorial Notes
04/11/2015: Publication reference added.
