Examination study on abdominal visceral fat reducing action by functional food intake -Randomized placebo-controlled double-blind parallel group comparison study-

Examination study on abdominal visceral fat reducing action by functional food intake -Randomized placebo-controlled double-blind parallel group comparison study- - Examination study on abdominal visceral fat reducing action by functional food intake

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026291

Enrollment

Registered

2017-04-07

Start date

2017-04-07

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

None listed

Interventions

Intake of test food for 12 weeks Intake of placebo food for 12 weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Males and females equal to or more than 20 years and less than 65 years of age 2. Subjects equal to or more than 24 and less than 30 kg/m^2 of BMI 3. Subjects who recognize the object and contents of the study and submit the written informed consent

Exclusion criteria

Exclusion criteria: 1. Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 2. Subjects who fall under the diagnostic criteria of metabolic syndrome 3. Subjects who received medication treatment or surgery due to serious illness or injury within 2 months from the start of this study 4. Subjects who use drugs of glycometabolism, lipidmetabolism, or reducing high blood pressure 5. Subjects who regularly use drugs, health foods, supplements which are suggested causal relationship from the study except who agree to quit taking them 6. Pregnant and lactating female, or who wish to get pregnant during the study period 7. Heavy dinkers 8. Subjects who feel bad mood by blood collection in past 9. Subjects who donated 200 mL or more of blood within 1 month from the start of the test or subjects who plan to do so during the test period 10. Subjects who have been constipated for more than 5 days 11. Shift worker 12. Subjects who have allergy related to the test foods 13. Subjects already participating in other clinical trials, subjects planning to participate during this examination period 14. Subjects who can not agree with the purpose of this test conducted in advance 15. Subjects who are ineligible due to physician's judgment

Design outcomes

Primary

Measure	Time frame
<Efficacy> Abdominal visceral fat area, at 8 and 12 weeks after intake <Safety> Side effect incidence	—

Secondary

Measure	Time frame
<Efficacy> Abdominal subcutaneous fat area and abdominal whole fat area, at 8 and 12 weeks after intake Waist circumference diameter, hip circumference diameter, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, and fasting blood glucose at 4,8 and 12 weeks after intake HbA1c and adiponectin at 12 weeks after intake <Safety> Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items	—

Measure

Time frame

<Efficacy> Abdominal subcutaneous fat area and abdominal whole fat area, at 8 and 12 weeks after intake Waist circumference diameter, hip circumference diameter, body weight, BMI, total cholesterol, HDL-cholesterol, LDL-cholesterol, and fasting blood glucose at 4,8 and 12 weeks after intake HbA1c and adiponectin at 12 weeks after intake <Safety> Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items

—

Countries

Japan

Contacts

Public ContactTomita Shimpei

New drug research center, Inc. Clinical Research Dept.

s-tomita@ndrcenter.co.jp0123-34-0412

Outcome results