UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031023
Receipt number R000035427
Scientific Title Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study
Date of disclosure of the study information 2019/01/01
Last modified on 2023/08/01 09:05:50

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Basic information

Public title

Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study

Acronym

Effects of Lactic acid bacteria R037 on
triglyceride elevation after high fat loading

Scientific Title

Effects of Lactic acid bacteria R037 on trigryceride elevation: randomized, double blind, placebo-controlled crossover study

Scientific Title:Acronym

Effects of Lactic acid bacteria R037 on
triglyceride elevation after high fat loading

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of lactic acid bacteria R037 on triglyceride level after high fat loading in subjects under normal high triglyceride level

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Efficacy:
1.Area under the triglyceride level-time curve
2.Changes of triglyceride level

Safety:
1. Doctor's questions
2. Subjective/Objective symptoms
3. Adverse events/Side effects
4. Blood pressures, Heart rate
5. Clinical laboratory tests at the end of the study

Key secondary outcomes

Efficacy:
1.Area under the RLP-cholesterol level-time curve
2.Changes of RLP-cholesterol level
3.Total cholesterol
4.HDL-cholesterol
5.LDL-cholesterol


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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Single ingestion of placebo tablets, and high fat loading

Interventions/Control_2

Single ingestion of active tablets containing 100 mg of lactic acid bacteria R037, and high fat loading

Interventions/Control_3

Single ingestion of active tablets containing 200 mg of lactic acid bacteria R037, and high fat loading

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1.Healthy men and women between 30 and 65 years of age
2.Fasting triglyceride level is between 80 and 149 mg/dL
3.Subject who don't have heavy drink habit
4.Agreed the informed consent

Key exclusion criteria

01.Under medication
02.Who can't stop to take supplements which may affect lipid metabolism during the study
03.Who can't stop drinking two days before screening and each examination
04.Who have an allergy to test substance
05.Who have severe disease(s) including diabetes, kidney/liver disease, heart disease, or who have metabolic disease(s) including thyroid gland disease, adrenal disease or who is under medical treatment
06.Who have chronic disease and is under medication
07.Who have digestive disease or surgery history of digestive organ(s) affecting digestion and absorption of foods
08.Inadequate subject judged by screening
09.Judged anemia by screening and cannot tolerate frequent blood sampling
10.Who has diarrhea within 1 week from date of screening
11.Blood drawing over 200 mL within 1 month or over 400 mL within 3 months from date of informed consent
12.Familial hyperlipidemia
13.Drug addict and alcohol addict
14.Who is attending another study using different food supplement(s), pharmaceutical(s), and cosmetic(s). Or who will attend another study
15.Under pregnant, or nursing, willing to become pregnant during the study
16.Person who is inappropriate for the study judged by medical doctor

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Yoshitaka
Middle name
Last name Iwama

Organization

Nihonbashi Cardiology Clinic

Division name

Director

Zip code

103-0001

Address

Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo

TEL

03-5641-4133

Email

yiwama@well-sleep.jp


Public contact

Name of contact person

1st name Yoshika
Middle name
Last name Komori

Organization

KSO Corporation

Division name

Sales department

Zip code

105-0023

Address

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

TEL

03-3452-7733

Homepage URL


Email

yoshikawa@kso.co.jp


Sponsor or person

Institute

KSO Corporation

Institute

Department

Personal name



Funding Source

Organization

Kaneka corporation

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

KOBUNA ORTHOPEDIC SURGERY

Address

311-2, Gokan-machi, Maebashi, Gunma

Tel

027-261-7600

Email

info@kobunaseikei.jp


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

2019 Year 01 Month 01 Day


Related information

URL releasing protocol

Under preparation

Publication of results

Unpublished


Result

URL related to results and publications

Under preparation

Number of participants that the trial has enrolled

24

Results

Under preparation

Results date posted

2020 Year 01 Month 30 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Under preparation

Participant flow

Under preparation

Adverse events

Under preparation

Outcome measures

Under preparation

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Preinitiation

Date of protocol fixation

2017 Year 12 Month 20 Day

Date of IRB

2018 Year 01 Month 11 Day

Anticipated trial start date

2018 Year 01 Month 29 Day

Last follow-up date

2018 Year 07 Month 03 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 26 Day

Last modified on

2023 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035427


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name