UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000048306
Receipt number R000055027
Scientific Title A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -
Date of disclosure of the study information 2022/07/06
Last modified on 2024/05/20 15:47:17

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Basic information

Public title

A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -

Acronym

A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -

Scientific Title

A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -

Scientific Title:Acronym

A study of the effect of continuous intake of test food on ketone body and lipid concentration. - an open-label trial -

Region

Japan


Condition

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This trial aims to investigate the effect of 2 weeks intake of the test food on blood and breath levels of ketone body and blood level of lipids.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Concentration of ketone bodies

Key secondary outcomes

Blood levels of triglycerides, total cholesterol, and LDL-cholesterol


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Take test food once a day at breakfast for 2 weeks.

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



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

50 years-old >

Gender

Female

Key inclusion criteria

1. Japanese females with aged 30 and 50 years at the time of informed consent
2. Those who regularly have three meals a day
3. Those who have no history, within 1 month, of intake of MCT oil or oils contains MCT at 60% or more
4. Those who fit to any of bellows,
- gained 10 kg or more of weight after 20th birthday and with current BMI between 25.0 and 30.0 kg/m^2.
- no significant change in the weight after 20th birthday and with current BMI between 18.0 and 25.0 kg/m^2.
5. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement

Key exclusion criteria

1. Those who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease
2. Those who are on diet/exercise therapy under the guidance of a doctor
3. Those who currently have or have history of severe diseases
4. Those who have serious anemia
5. Those who daily take medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods on the market that have health claims related to fatigue, stress relief, cold intolerance, blood flow, blood pressure or calefacient (excluding individuals who can refrain from ingestion after receiving informed consent until the end of the study)
6. Those who currently have or have a history of drug and/or food allergies
7. Those who have donated 200 mL of the blood, including ingredient blood, within 1 months before start of the study
8. Those who have donated 400 mL of the blood within 4 months before start of the study
9. Those who joined other clinical trials within 1 month before receiving informed consent in this study, or those who are currently joining other clinical trials
10. Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period.
11. Those who routinely take alcohol more than 60 g/day
12. Those who have smoked within a year
13. Those who cannot agree to abandon daily exercise from 3 days before start of food intake until end of the study
14. Those who have habits of irregular meals, or those who have irregular life rhythm such as night work or spilt shift
15. Those who are judged by the physician to be unsuitable for this study.

Target sample size

12


Research contact person

Name of lead principal investigator

1st name Hiroyuki
Middle name
Last name Shimizu

Organization

Medical corporation Seishukai
Hasegawa Hospital

Division name

Hospital director

Zip code

116-0014

Address

5-45-7 Higashinippori, Arakawa-ku, Tokyo, Japan

TEL

03-3807-8866

Email

clinical-trial@imeqrd.co.jp


Public contact

Name of contact person

1st name Yoshitada
Middle name
Last name Hira

Organization

IMEQRD Co., Ltd

Division name

Planning and Sales Department

Zip code

104-0061

Address

6-2-1 Ginza Chuo-ku Tokyo Japan

TEL

03-6704-5968

Homepage URL

https://imeqrd.co.jp/

Email

clinical-trial@imeqrd.co.jp


Sponsor or person

Institute

IMEQRD Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Integrate 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

Suda Clinic institutional review board

Address

2-8-14,Takadanobaba,Shinjuku-ku,Tokyo

Tel

03-6704-5968

Email

jimukyoku@imeqrd.co.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

2022 Year 07 Month 06 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

2022 Year 06 Month 25 Day

Date of IRB

2022 Year 06 Month 28 Day

Anticipated trial start date

2022 Year 07 Month 07 Day

Last follow-up date

2022 Year 08 Month 04 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2022 Year 07 Month 06 Day

Last modified on

2024 Year 05 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055027