UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of subacute ingestion of chlorogenic acids on sleep architecture and energy metabolism through activity of autonomic nervous system. A randomized, placebo-controlled, double-blind, crossover trial.
Title of the study (Brief title)	Effects of subacute ingestion of chlorogenic acids on sleep architecture and energy metabolism through activity of autonomic nervous system.
Region	Japan

Condition
Condition	Obesity.
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Present study evaluates the effects of 600mg CGAs ingestion on sleep architecture, energy metabolism and autonomic nervous function in healthy male and female subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	To evaluate the energy metabolism in human calorimeter, 5 days continuously intake of chlorogenic acids 600mg.
Key secondary outcomes	To evaluate the quality of sleep in human calorimeter, 5 days continuously intake of chlorogenic acids 600mg.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	During the each session of 5-day, the test beverage containing 600 mg of Chlorogenic acids was consumed 10 min before bedtime.
Interventions/Control_2	During the each session of 5-day, the test beverage containing 0 mg (placebo) was consumed 10 min before bedtime.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Good sleeper and healthy male or female. 2) Body mass index (BMI) is more than 18.5 and less than 30. 3) Age is more than 18 and less than 59 years old.
Key exclusion criteria	1) Change body weight plus or minus 2.0kg before a month. 2) Pregnant. 3) Severe problem in the menstrual cycle. 4) Engaged in regular exercise more than twice a week. 5) Use any regular or temporary medication. 6) Smokers. 7) Drinking more than a bottle of alcohol (350 ml) per day. 8) clinical diagnosis (apnea sleep hypopnea) or medical/psychiatric condition. 9) shift workers.
Target sample size	10

Research contact person
Name of lead principal investigator	Kumpei Tokuyama
Organization	University of Tsukuba
Division name	Graduate school of comprehensive human sciences
Address	Laboratory of Advanced Research D508, 1-1-1 Tennodai, Tsukuba, Ibaraki, JAPAN
TEL	029-853-3963
Email	tokuyama@taiiku.tsukuba.ac.jp

Public contact
Name of contact person	Insung PARK
Organization	University of Tsukuba
Division name	Graduate school of comprehensive human sciences
Address	Laboratory of Advanced Research D506, 1-1-1 Tennodai, Tsukuba, Ibaraki, JAPAN
TEL	090-9238-9996
Homepage URL
Email	tsukubapark@gmail.com

Sponsor
Institute	Human Health Care of Product Development Research, Kao Corporation
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Human Health Care of Product Development Research, Kao Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	筑波大学（茨城県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 01 Day
Anticipated trial start date	2013 Year 01 Month 21 Day
Last follow-up date	2013 Year 07 Month 30 Day
Date of closure to data entry	2013 Year 08 Month 01 Day
Date trial data considered complete	2013 Year 08 Month 07 Day
Date analysis concluded	2013 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Fat oxidation was significantly higher in trials with chlorogenic ingestion compared to that of control trial. Sleep latency was shorter in trials with chrologenic ingestion.
Other related information

Management information
Registered date	2016 Year 06 Month 26 Day
Last modified on	2016 Year 06 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026330