UMIN-CTR Clinical Trial

Public title

Effect of a Functional Food for Postprandial Triglyceride.

Acronym

Effect of a Functional Food for Postprandial Triglyceride.

Scientific Title

Effect of a Functional Food for Postprandial Triglyceride.

Scientific Title:Acronym

Effect of a Functional Food for Postprandial Triglyceride.

Region

Japan

Condition

N/A (healthy adults)

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine effect of a functional food for postprandial triglyceride.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Efficacy evaluation (changes, increase and decrease, Cmax, delta Cmaxm AUC and iAUC of TG and NEFA⁽¹⁾; blood viscosity and lipid composition analysis⁽²⁾).
⁽¹⁾: Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 2, 3, 4, 6 hours after ingestion of a challenge diet).
⁽²⁾: Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet).

Key secondary outcomes

*Safety
[1]Blood pressure, pulsation⁽¹⁾.
[2]Weight, body fat percentage, BMI⁽²⁾.
[3]Doctor's questions⁽¹⁾.
[4]Subject's diary⁽³⁾.

*Other indexes
[1]Hematologic test⁽⁴⁾.
[2]Blood biochemical test⁽²⁾.
[3]Urine analysis⁽⁴⁾.
[4]Anti-Aging QOL Common Questionnaire⁽²⁾.

⁽¹⁾:Screening; Week 0, Week 4 (before ingestion of a challenge diet, and 6 hours after ingestion of a challenge diet).
⁽²⁾:Screening; Week 0, Week 4 (before ingestion of a challenge diet).
⁽³⁾:From two days before ingestion of a challenge diet in observation period I to one day before ingestion of a challengediet in Week 4.
⁽⁴⁾:Screening.
⁽⁵⁾: Week 0, Week 4 (before ingestion of a challenge diet).

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

[1]Oral Fat Tolerance Test (1 time).
[2]Oral intake of the tes food (6 tablets in a day; 4 weeks).
[3]Oral Fat Tolerance Test (1 time).

Interventions/Control_2

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 aged 20-64 years.
[2]Individuals who are healthy and are not suffered from a chronic malady including skin disease.
[3]Individuals whose triglyceride level is high-normal (120-149 mg/dL) or who are mild hyperlipemia
(150-199mg/dL).
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can visit an inspection facility and be inspected in designated days.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who are or are under treatment or have a history of hyperlipidemia, hypertension, diabetes, mental disabilities, sleep disorder or the other serious dysfunctions.
[3]Individuals who used a drug to treat in the past 1 month (One-shot medicine of a headache, menstrual pain and a cold removes it).
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung disease, or blood disease.
[5]Individuals who have digestive organ disease (disease of an appendix is removed).
[6]Individuals whose menstrual period is during the test period and with serious anemia or poor physical condition during the period (only for females).
[7]Individuals whose BMI is over 30kg/m².
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals with serious anemia.
[10]Individuals who are difficult to conduct blood collections over time.
[11]Individuals who are sensitive to test products or causes severe allergy in a food and medical supplies.
[12]Individuals who cannot intake every diet the day before the inspection day or every loading food.
[13]Individuals who are based on average alcohol per 1 day and exceeds 60g/day.
[14]Individuals whose life style will change during the test period (ex. travel for a long time).
[15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements which adopt to improve lipid metabolism or glucose metabolism in the past 3 months or will ingest those foods during the test period.
[16]Individuals who are or are possibly pregnant, or are lactating.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individuals judged inappropriate for the study by the principal.

Target sample size

17

Name of lead principal investigator

1st name	Hiroaki
Middle name
Last name	Kondo

Organization

Medical Corporation Meiseikai, Higashi Shinjuku Clinic

Division name

Head

Zip code

169-0072

Address

3F Daito Bldg. 1-11-3 Okubo Shinjuku-ku Tokyo 169-0072, JAPAN

TEL

+81-3-6233-8583

Email

h.kondo@meiseikai-cl.com

Name of contact person

1st name	Ryoma
Middle name
Last name	Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

KOBAYASHI Pharmaceutical Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

i.takahashi@tes-h.co.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

2020

Year

11

Month

06

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

2020

Year

10

Month

23

Day

Date of IRB

2020

Year

10

Month

26

Day

Anticipated trial start date

2020

Year

11

Month

18

Day

Last follow-up date

2020

Year

12

Month

23

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

11

Month

05

Day

Last modified on

2021

Year

06

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048321