UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015908 |
|---|---|
| Receipt number | R000018517 |
| Scientific Title | Double-blind, placebo-controlled study for the effects of the extract from roasted chicory root on lipid metabolism. |
| Date of disclosure of the study information | 2014/12/10 |
| Last modified on | 2015/10/06 09:07:06 |
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Basic information
Public title
Double-blind, placebo-controlled study for the effects of the extract from roasted chicory root on lipid metabolism.
Acronym
Effects of the extract from roasted chicory root on lipid metabolism.
Scientific Title
Double-blind, placebo-controlled study for the effects of the extract from roasted chicory root on lipid metabolism.
Scientific Title:Acronym
Effects of the extract from roasted chicory root on lipid metabolism.
Region
| Japan |
Condition
Condition
dyslipidemia
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The main purpose is to evaluate the effectiveness of continuous ingestion (300ml/day for 4 weeks) of the extract from roasted chicory root on lipid dyslipidemia in a double-blind, placebo-controlled study. Additionally to evaluate the benefits of chicory root in glucose metabolism and fecal property.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
LDL-Cho,serum adiponectin
Key secondary outcomes
Lipid metabolism (T-cho, TG, HDL-cho), blood glucose (FBG, HbA1c, Insulin), VAS questionnaire (defecation frequency etc.) , Body composition (weight, BMI, fat percentage)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Ingesting 300 ml of the effects of roasted chicory root daily for 4 weeks.
Interventions/Control_2
Ingesting 300 ml of barley tea containing 10% coffee (placebo) for 4 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
(1)Subjects who are under medication for chronic ailments.
(2) Subjects with serious diseases and infections.
(3) Subjects with clinical history of gastrointestinal surgery.
(4) Subjects having a family history
of hypercholesterolemia
(5) Subjects with frequent complaints of post-menopausal symptoms.
(6) Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
(7) Subjects with serious anemia.
(8) Subjects with a history of allergy to medicine and food, especially dairy products.
(9) Subjects routinely on supplementation which would affect the lipid metabolism.
(10) Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
(11) Subjects who donate 400ml whole blood within 12 weeks or who donate plasma or platelets within 4 weeks prior to supplementation.
(12) Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
(13) Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
(14) Subjects who are not eligible due to physician's judgment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido Japan.
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido Japan
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
NOASTEC Foundation (Northern Advancement Center for Science and Technology)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Hokusho university
Name of secondary funder(s)
Tenshin farm
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
北海道情報大学 保健センター(北海道)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.sciencedirect.com/science/article/pii/S2225411014000303
Number of participants that the trial has enrolled
Results
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
| 2013 | Year | 08 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 30 | Day |
Last follow-up date
| 2014 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2014 | Year | 02 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 10 | Day |
Last modified on
| 2015 | Year | 10 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018517
