UMIN-CTR Clinical Trial

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

dyslipidemia

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

YES

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

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)

Study type

Interventional

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

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

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

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

Email

nishihira@do-johodai.ac.jp

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

Email

nishihira@do-johodai.ac.jp

Institute

Hokkaido Information University

Institute

Department

Personal name

Organization

NOASTEC Foundation (Northern Advancement Center for Science and Technology)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan

Co-sponsor

Hokusho university

Name of secondary funder(s)

Tenshin farm

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道情報大学　保健センター(北海道)

Date of disclosure of the study information

2014

Year

12

Month

10

Day

URL releasing protocol

Publication of results

Published

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

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 related 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