UMIN-CTR Clinical Trial

Public title

Clinical trial to evaluate Capsicum annuum L intake on serum glucose level after glucose load in healthy human.

Acronym

Clinical trial with Capsicum annuum L

Scientific Title

Clinical trial to evaluate Capsicum annuum L intake on serum glucose level after glucose load in healthy human.

Scientific Title:Acronym

Clinical trial with Capsicum annuum L

Region

Japan

Condition

Healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study is to evaluate the efficacy of Capsicum annuum L intake on serum glucose level after meal.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

glucose level (at min-0, min-30, min-60 and min-120)

Key secondary outcomes

AUC of glucose level

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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

Cooked chilli peppers (Capsicum annuum L)
100 g/meal
Once a day

Interventions/Control_2

Placebo containing the three major nutrients
100 g/meal
Once a 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

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>

Gender

Male and Female

Key inclusion criteria

(1) Non smokers
(2) Persons who will generally be judged as healthy
(3) Persons who have never suffered from asthma
(4) Persons who have never developed any allegic reaction to medicines, foods, or other substances.
(5) Persons who will give written informed consent by theirselves

Key exclusion criteria

(1) Persons who have any dietary supplements, quasi drugs or medicines which cause same or similar efficacy with the effect evaluated in this study.
(2) Persons who changed their habitats of supplements within 4 weeks.
(3) Persons who work in night shift or in day and night shift.
(4) Persons who have been treated their illness or prevention in a clinic at their informed consent
persons with their medical histories as follows: serious diseases of Sugar metabolism,lipid metabolism, liver function, renal function, heart, circulatory, respiratory, endocrine system, immune system, or mental illness of the nervous system.
(6) Persons with the medical histories of alcoholism or drug dependence.
(7) Prsons who might be developed allergic reaction to foods.
(8) Persons who are pregnant, breast-feeding, or hope to be pregnant during the study period.
(9) Persons who had always participated in or will participate in any other clinical trial (to use foods/medicine/quasi medicine/medical device)
(10) Persons who will not be judged suitable to the participants by the investigator.

Target sample size

10

Name of lead principal investigator

1st name
Middle name
Last name	Koichiro Ohnuki

Organization

Kindai University

Division name

Department of Biological & Environmental

Zip code

Address

11-6, Kayanomori, Iizukacity, Fukuoka

TEL

0948-22-5655

Email

ohnuki@fuk.kindai.ac.jp

Name of contact person

1st name
Middle name
Last name	Koichiro Ohnuki

Organization

Kindai University

Division name

Department of Biological & Environmental

Zip code

Address

11-6, Kayanomori, Iizukacity, Fukuoka

TEL

0948-22-5655

Homepage URL

Email

ohnuki@fuk.kindai.ac.jp

Institute

Kinki University
Department of Biological & Environmental Chemistry
Faculty of Human-Oriented Science and Engineering

Institute

Department

Personal name

Organization

Pharmacy Solutions Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2017

Year

06

Month

13

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

2016

Year

06

Month

08

Day

Date of IRB

Anticipated trial start date

2016

Year

06

Month

20

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2016

Year

06

Month

13

Day

Last modified on

2017

Year

12

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026119