UMIN-ICDS Clinical Trial

Public title

The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-

Acronym

The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-

Scientific Title

The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-

Scientific Title:Acronym

The evaluation of suppressive effect of a supplement containing complex ingredients on absorption of triglyceride.-A randomized double-blind, placebo-controlled crossover trial-

Region

Japan

Condition

Healthy subjects with normal level or slightly higher than normal level of fasting serum triglyceride

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of a supplement containing complex ingredients on postprandial serum triglyceride (TG) and its safety.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Comparison of area under the concentration curve (AUC) in the change of triglyceride levels between groups after single ingestion.

Key secondary outcomes

Comparison of area under the concentration curve (AUC) in the triglyceride levels as is between groups after single ingestion.
Between group comparison of triglyceride levels using measured values, or change values from before lipid load, at each blood collection time point after single ingestion.
Between group comparison of remnant-like lipoprotein cholesterol levels using measured values, or change values from before lipid load, at each blood collection time point after single ingestion as well as comparison for those for the area under the concentration curve (AUC).
Effects on the intestinal microflora after 7 days consecutive ingestion of test food.

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ingestion of the placebo food(7 days) - washout period (3 weeks or more) - ingestion of the test food(7 days)

Interventions/Control_2

Ingestion of the test food (7 days) - washout period (3 weeks or more) - ingestion of the placebo food(7 days)

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

20

years-old

<=

Age-upper limit

65

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Japanese males and females between the ages of 20 and 64 years old at the time of giving consent to participate in the study.
(2) Subjects whose fasting triglyceride level is less than 200 mg/dL before lipid load at screening.
(3) Subjects who can be available to the test site on the visit dates.
(4) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.

Key exclusion criteria

(1) Subjects with history of hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious illness.
(2) Subjects with a surgical history of digestive system (except appendicectomy).
(3) Subjects with chronic diseases under treatment.
(4) Subjects with food allergies to the food ingredients used in the study.
(5) Subjects who are pregnant or intend to become pregnant during the study or are lactating.
(6) Subjects who are lactose intolerant or are susceptible to high-fat foods to show gastrointestinal symptoms.
(7) Heavy drinkers (average amount of intake as pure alcohol is 60 g or more per day) or excessive smokers (smoke more than 20 cigarettes per day).
(8) Subjects who always take drugs or supplements which claim the effects such as suppressive absorption of sugar or lipid, or reduction of triglyceride, etc.
(9) Subjects who participate in other clinical trial.
(10) Subjects who may feel unwell or deteriorate due to repeated blood collection.
(11) Subjects who have donated or plan to donate 200 ml or more of blood separately from this study from 1 month before the primary screening to the end of the study.
(12) Subjects who have a habit of skipping meals.
(13) Subjects who work from 22:00 to 6:00 (shift workers, late night workers, etc., including part-time workers)
(14) Subjects who due to religious or other reasons need to avoid consuming foods whose origin is not clearly indicated.
(15) Subjects judged as unsuitable for this study by the investigator with other reasons.

Target sample size

50

Name of lead principal investigator

1st name	Hideyuki
Middle name
Last name	Kunishige

Organization

Medical Corporation Shoureikan Shin-Sapporo Seiryou Hospital

Division name

Internal medicine

Zip code

004-0004

Address

2-1-30, Atubetsuhigashi4jo, Atubetsu-ku, Sapporo, Hokkaido, Japan

TEL

011-898-2151

Email

ishikawa@hpgr.jp

Name of contact person

1st name	Isao
Middle name
Last name	Takehara

Organization

Clinical Support Corporation, Limited

Division name

Food Service Division

Zip code

060-0061

Address

4-1, South 1 West 8, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-223-3130

Homepage URL

Email

takehara@csc-smo.co.jp

Institute

Medical Corporation Shoureikan Shin-Sapporo Seiryou Hospital

Institute

Department

Personal name

Organization

FUJIFILM Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical corporation Hokubukai UtsukushigaokaHospital Ethics Review Committee

Address

No. 61, Maeda, Kiyota-ku, Sapporo, Hokkaido

Tel

011-882-0111

Email

matsuda@ughp-cpc.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

12

Month

31

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2023

Year

01

Month

24

Day

Date of IRB

2023

Year

01

Month

26

Day

Anticipated trial start date

2023

Year

03

Month

24

Day

Last follow-up date

2023

Year

06

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

03

Month

15

Day

Last modified on

2024

Year

03

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057575