UMIN-ICDS Clinical Trial

Unique ID issued by UMIN UMIN000060773
Receipt number R000069530
Scientific Title A study to verify the suppressive effect of the test food on postprandial blood glucose elevation: a randomized, placebo-controlled, double-blind, crossover comparison study
Date of disclosure of the study information 2026/02/27
Last modified on 2026/02/27 09:06:04

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Basic information

Public title

A study to verify the suppressive effect of the test food on postprandial blood glucose elevation: a randomized, placebo-controlled, double-blind, crossover comparison study

Acronym

A study to verify the suppressive effect of the test food on postprandial blood glucose elevation: a randomized, placebo-controlled, double-blind, crossover comparison study

Scientific Title

A study to verify the suppressive effect of the test food on postprandial blood glucose elevation: a randomized, placebo-controlled, double-blind, crossover comparison study

Scientific Title:Acronym

A study to verify the suppressive effect of the test food on postprandial blood glucose elevation

Region

Japan


Condition

Condition

Healthy Japanese

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effect of the test food consumption on suppressing postprandial blood glucose elevation in healthy Japanese.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

1. The incremental area under the curve (IAUC) for glucose (GLU)

Key secondary outcomes

1. The maximum blood concentration (Cmax) of GLU, and the measured values of GLU at each time point (before and 30, 60, 90, and 120 minutes after the load) and their changes from before the load

2. The IAUC and Cmax of insulin, and the measured values of insulin at each time point (before and 30, 60, 90, and 120 minutes after the load) and their changes from before the load

3. Individuals who experienced adverse events

4. Systolic and diastolic blood pressure in Test 1, Test 2, and Test 3


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

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

Central registration


Intervention

No. of arms

3

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Food

Interventions/Control_1

<Duration>
Single ingestion (three times)

<Test product>
Test 1: Green rooibos HCP active capsule + Green rooibos HCP placebo capsule
Test 2: Green rooibos HCP active capsule
Test 3: Green rooibos HCP placebo capsule

<Carbohydrate load>
Trelan(R) G 75 g

<Administration>
Test 1: Four capsules per intake (2 green rooibos HCP active capsules + 2 green rooibos HCP placebo capsules)
Test 2: Four capsules per intake (4 green rooibos HCP active capsules)
Test 3: Four capsules per intake (green rooibos HCP placebo capsules)

*The intervention sequence is Test 1, Test 2, and Test 3.
*The washout period is at least one week.

Interventions/Control_2

<Duration>
Single ingestion (three times)

<Test product>
Test 1: Green rooibos HCP active capsules
Test 2: Green rooibos HCP placebo capsules
Test 3: Green rooibos HCP active capsules + Green rooibos HCP placebo capsules

<Carbohydrate load>
Trelan(R) G 75 g

<Administration>
Test 1: Four capsules per intake (4 green rooibos HCP active capsules)
Test 2: Four capsules per intake (green rooibos HCP placebo capsules)
Test 3: Four capsules per intake (2 green rooibos HCP active capsules + 2 green rooibos HCP placebo capsules)

*The intervention sequence is Test 1, Test 2, and Test 3.
*The washout period is at least one week.

Interventions/Control_3

<Duration>
Single ingestion (three times)

<Test product>
Test 1: Green rooibos HCP placebo capsules
Test 2: Green rooibos HCP active capsules + Green rooibos HCP placebo capsules
Test 3: Green rooibos HCP active capsules

<Carbohydrate load>
Trelan(R) G 75 g

<Administration>
Test 1: Four capsules per intake (green rooibos HCP placebo capsules)
Test 2: Four capsules per intake (2 green rooibos HCP active capsules + 2 green rooibos HCP placebo capsules)
Test 3: Four capsules per intake (4 green rooibos HCP active capsules)

*The intervention sequence is Test 1, Test 2, and Test 3.
*The washout period is at least one week.

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

40 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Japanese

2. Men or women

3. Individuals aged >=40 and <=64 years

4. Healthy individuals

5. Individuals whose fasting blood glucose level is <=125 mg/dL
and whose 2-hour blood glucose level during a 75 g OGTT is <=199 mg/dL

6. Individuals whose Cmax of blood glucose following a 75 g OGTT is >=140 mg/dL and <=199 mg/dL

7. Individuals whose IAUC for blood glucose during a 75 g OGTT load at screening is relatively high

8. Individuals whose BMI is >=18.5 kg/m2 and <30 kg/m2

Key exclusion criteria

1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

5. Individuals who are taking or using medications (including herbal medicines) or supplements

6. Individuals who are allergic to medicines or foods related to the test product

7. Individuals who are smokers or have not yet completed one year since quitting smoking

8. Individuals who are pregnant, lactating, or planning to become pregnant during this study

9. Individuals who have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study

10. Individuals who are judged as ineligible to participate in this study by the physician

Target sample size

18


Research contact person

Name of lead principal investigator

1st name Tsuyoshi
Middle name
Last name Takara

Organization

Medical Corporation Seishinkai, Takara Clinic

Division name

Director

Zip code

141-0022

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

TEL

03-5793-3623

Email

t-takara@takara-clinic.com


Public contact

Name of contact person

1st name Naoko
Middle name
Last name Suzuki

Organization

ORTHOMEDICO Inc.

Division name

R&D Department

Zip code

112-0002

Address

2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan

TEL

03-3818-0610

Homepage URL


Email

nao@orthomedico.jp


Sponsor or person

Institute

Nikken Foods Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Nikken Foods 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

The ethical committee of the Takara Clinic, Medical Corporation Seishinkai

Address

9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan

Tel

03-5793-3623

Email

IRB@takara-clinic.com


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

医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)


Other administrative information

Date of disclosure of the study information

2026 Year 02 Month 27 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

Open public recruiting

Date of protocol fixation

2026 Year 02 Month 18 Day

Date of IRB

2026 Year 02 Month 18 Day

Anticipated trial start date

2026 Year 02 Month 27 Day

Last follow-up date

2026 Year 06 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2026 Year 02 Month 27 Day

Last modified on

2026 Year 02 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069530