Effects of consumption of the test food containing black turmeric (Kaempferia parviflora) extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial

Effects of consumption of the test food containing black turmeric (Kaempferia parviflora) extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, parallel-group trial - Effects of consumption of the test food containing black turmeric (Kaempferia parviflora) extract on fasting blood glucose level, and a verification study for safety evaluation of excessive the test food ingestion

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000033426

Enrollment

Registered

2018-07-18

Start date

2018-07-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Japanese subjects

Interventions

Duration: 12 weeks Test material: Tablet containing black turmeric (Kaempferia parviflora) extract &lt

from the starting date to intake through the examination at 8 weeks after consumption&gt

Dose: Take 2 tablets per day Administration: Take 2 tablets with water or warm water after breakfast &lt

from the examination at 8 weeks after consumption through the examination at 12 weeks after consumption&gt

Dose: Take 10 tablets per day Administration: Take 10 tablets any time during the day with water or warm water * If you forget to take tablets, take these as soon as you remember within the day. D

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy Japanese adult subjects who are anxious in blood glucose level 2. Subjects who are judged as eligible to participate in the study by the physician 3. Within the subjects who met the 1st and 2nd inclusion criteria, subjects between 110 mg/dL or more and 125 mg/dL or less in fasting blood glucose at screening (before consumption) 4. When number of subjects who passed the inclusion criteria are below the sample size, select those whose fasting blood glucose levels are in a relatively high normal range (less than 110 mg/dL)

Exclusion criteria

Exclusion criteria: 1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, myocardial infarction 2. Currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily *Particularly taking food/beverage effective in lowering blood sugar in daily 4. Subjects who are currently taking medications (including herbal medicines) and supplement *Particularly taking antihypertensive drugs in daily 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are pregnant, breast-feeding, or planning to become pregnant 7. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 8. Subjects who are judged as ineligible to participate in the study by the physician

Design outcomes

Primary

Measure	Time frame
1. Fasting blood glucose level * Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change.	—

Secondary

Measure	Time frame
1. Hemoglobin A1c (HbA1c) level 2. Serum glycoalbumin level 3. Serum insulin level 4. Plasma pentosidine level 5. Vascular age 6. Vascular age score 7. Value of Schirmer's test (right eye, left eye, the average in both eyes, dominant eye, and non-dominant eye) 1-7 Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change. 5,6 Measure the items by Medical Analyzer. 7 Measure the item by Schirmer tear test strips. <Safety evaluation items> 1. Physical examination 2. Urinalysis 3. Blood test 1-3 Measure the values at 8 and 12 weeks after consumption and calculate the amount of change. *2 Measure the values at 8 and 12 weeks after consumption.	—

Measure

Time frame

1. Hemoglobin A1c (HbA1c) level 2. Serum glycoalbumin level 3. Serum insulin level 4. Plasma pentosidine level 5. Vascular age 6. Vascular age score 7. Value of Schirmer's test (right eye, left eye, the average in both eyes, dominant eye, and non-dominant eye) *1-7 Measure the values at screening (before consumption) and 8 and 12 weeks after consumption and calculate the amount of change. *5,6 Measure the items by Medical Analyzer. *7 Measure the item by Schirmer tear test strips. <Safety evaluation items> 1. Physical examination 2. Urinalysis 3. Blood test *1-3 Measure the values at 8 and 12 weeks after consumption and calculate the amount of change. *2 Measure the values at 8 and 12 weeks after consumption.

—

Countries

Japan

Contacts

Public ContactNaoko SUZUKI

ORTHOMEDICO Inc. R&D Department

nao@orthomedico.jp03-3818-0610

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026