Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060773) titled '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' on Feb. 27.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Nikken Foods Co., Ltd.

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effect of the test food consumption on suppressing postprandial blood glucose elevation in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Single ingestion (three times)

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

Trelan(R) G 75 g

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 - Single ingestion (three times)

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

Trelan(R) G 75 g

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.

Eligibility: Age-lower limit - 40 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men or women

3. Individuals aged >=40 and =140 mg/dL and =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 Size - 18

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069530

Disclaimer: Curated by HT Syndication.