Condition category
Nutritional, Metabolic, Endocrine
Date applied
14/07/2015
Date assigned
06/10/2015
Last edited
04/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Sponsor information

Organisation

University of Shizuoka (Japan)

Sponsor details

52-1
Yada
Suruga-ku
Shizuoka
422-8526
Japan

Sponsor type

University/education

Website

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

Publication citations

Additional files

Editorial Notes

04/11/2015: Publication reference added.