UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022889 |
|---|---|
| Receipt number | R000026330 |
| Scientific Title | 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. |
| Date of disclosure of the study information | 2016/06/27 |
| Last modified on | 2016/06/26 12:04:07 |
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Basic information
Public title
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.
Acronym
Effects of subacute ingestion of chlorogenic acids on sleep architecture and energy metabolism through activity of autonomic nervous system.
Scientific Title
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.
Scientific Title:Acronym
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.
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
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
| 1st name | |
| Middle name | |
| Last name | Kumpei Tokuyama |
Organization
University of Tsukuba
Division name
Graduate school of comprehensive human sciences
Zip code
Address
Laboratory of Advanced Research D508, 1-1-1 Tennodai, Tsukuba, Ibaraki, JAPAN
TEL
029-853-3963
tokuyama@taiiku.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Insung PARK |
Organization
University of Tsukuba
Division name
Graduate school of comprehensive human sciences
Zip code
Address
Laboratory of Advanced Research D506, 1-1-1 Tennodai, Tsukuba, Ibaraki, JAPAN
TEL
090-9238-9996
Homepage URL
tsukubapark@gmail.com
Sponsor or person
Institute
Human Health Care of Product Development Research, Kao Corporation
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
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.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
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 |
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026330
