A study of effective dietary therapy to control of hyperphosphatemia
| ISRCTN | ISRCTN13160049 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13160049 |
| Secondary identifying numbers | University hospital Medical Information Network (UMIN)/UMIN000014380 |
- 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
| Study design | interventional randomized crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Other |
| Study type | Prevention |
| 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 | 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 study start date | 13/07/2013 |
| Completion date | 08/01/2015 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Male |
| Target number of participants | 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
Sponsor information
University/education
52-1, Yada, Suruga-ku
Shizuoka
422-8526
Japan
"ROR" |
https://ror.org/01w6wtk13 |
|---|
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | To be confirmed at a later date |
| 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.
