UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022015
Receipt number R000025369
Scientific Title A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the suppression of the elevation of postprandial serum triglyceride. -Randomised double-blind placebo-controlled trial
Date of disclosure of the study information 2016/04/22
Last modified on 2022/06/24 16:18:23

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Basic information

Public title

A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the suppression of the elevation of postprandial serum triglyceride. -Randomised double-blind placebo-controlled trial

Acronym

A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the suppression of the elevation of postprandial serum triglyceride. -Randomised double-blind placebo-controlled trial

Scientific Title

A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the suppression of the elevation of postprandial serum triglyceride. -Randomised double-blind placebo-controlled trial

Scientific Title:Acronym

A clinical study for evaluating the efficacy of soft drink containing reduced type of indigestible dextrin on the suppression of the elevation of postprandial serum triglyceride. -Randomised double-blind placebo-controlled trial

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the efficacy of soft drink containing reduced type of indigestible dextrin on the suppression of the elevation of postprandial serum triglyceride after ingesting high fat meal.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time course of serum triglyceride level and AUC (area under the curve)(0-6hrs)

Key secondary outcomes

Time course of serum RLP-cholesterol level and AUC (area under the curve)(0-6hrs).
Time course of serum level in total cholesterol, HDL cholesterol, LDL cholesterol, phospholipids, free fatty acids, beta-lipoprotein, glucose and insulin(0-6hrs)


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


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Soft drink containing reduced type of indigestible dextrin (1 day)

Interventions/Control_2

Soft drink not containing reduced type of indigestible dextrin (1 day)

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

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

(1) (Healthy) Individuals aged 20 to 64 years old
(2) Individuals whose fasting serum triglyceride levels are from 120 mg/dL to 199 mg/dL.
(3) Individuals giving written informed consent

Key exclusion criteria

(1) Individuals who use oral medication affecting lipid metabolism
(2) Individuals who constantly use supplements and/or functional foods, including food for specified health use and/or food with function claims, affecting lipid metabolism
(3) Individuals whose IBM is less than 18 or 30 and over at the screening checkup
(4) Individuals who can't stop drinking for 2 days until the screening checkup
(5) Individuals who declare the allergy symptoms against high-fat diets
(6) Individuals who are suffered from or under treatment of serious disease (e.g., diabetes, liver disease, kidney disease, and/or heart disease), thyroid gland disease, adrenal gland disease, and/or metabolic disorder
(7) Individuals who have a chronic disease and use medicines continuously
(8) Individuals who have a history of digestive disease and/or surgical history affecting digestion and absorption
(9) Individuals who are judged as unsuitable for the study based on the results of blood test
(10) Individuals who have donated over 200 mL of blood and/or blood component within the last one month prior to the current study or over 400 mL of blood and/or blood component within the last three months prior to the current study.
(11) Individuals who are diagnosed as familial hyperlipidemia
(12) Individuals who are diagnosed as severe anemia and not suitable for frequent collection of blood
(13) Individuals who are under treatment or have a history of drug/alcohol dependence
(14) Individuals who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics
(15) Individuals who are pregnant or breast-feeding, or have the will of pregnancy during the study period
(16) Individuals who are judged as unsuitable for the study by the investigator for the other reasons

Target sample size

90


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yoshitaka Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code


Address

13-4 Kodenmacho, Nihonbashi, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yoshika Komori

Organization

KSO Corporation

Division name

Sales department

Zip code


Address

1-9-7 Shibaura, Minato-ku, Tokyo

TEL

03-3452-7733

Homepage URL


Email

yoshi@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Coca-Cola(Japan) Co., Ltd.

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


Email



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



Other administrative information

Date of disclosure of the study information

2016 Year 04 Month 22 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


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

2016 Year 03 Month 23 Day

Date of IRB

2016 Year 04 Month 04 Day

Anticipated trial start date

2016 Year 04 Month 23 Day

Last follow-up date

2016 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 04 Month 21 Day

Last modified on

2022 Year 06 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025369


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name