A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat-Randomized, double-blind, placebo-controlled parallel group study-

A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat-Randomized, double-blind, placebo-controlled parallel group study- - A study to evaluate the effects of intake with food containing multiple ingredients on the reduction of including visceral fat

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000046535

Enrollment

Registered

2023-03-01

Start date

2022-01-07

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 1 Intake of test food 2 Intake of placebo food

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Males and females aged of 20-64 years 2) Subjects with BMI >=23 kg/m2 and <30 kg/m2 at the time of screening test 3) Subjects who can visit on schedule days 4) Subjects who recognize the object and contents of the study and submit the written informed consent

Exclusion criteria

Exclusion criteria: 1) Subjects who fall under the diagnostic criteria of metabolic syndrome 2) Subjects who are under treatment of liver disease, kidney disease, heart disease, respiratory disease, endocrine disease, metabolic disease, neurological disease, consciousness disease, diabetes disease, other disorders 3) Subjects who are have a history of cardiovascular disease 4) Subjects who do not intakecarbohydrates (rice, bread, noodles) for all three meals a day 5) Subjects who use oral medication or supplements which may affect this study 6) Subjects who are sensitive to medical products, and other foods 7) Subjects who have experienced sickness due to blood collection 8) Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period 9) Subjects who participated in other clinical studies in the past 1 months 10) Subjects who usually intake heavy amount of alcohol (40g alcohol/day>=) and who are excessive smoker(21 cigarettes/day>=) 11) Subjects who with irregular eating habits. (Night shift worker) 12) Subjects who wish to become pregnant during the study periods( including the possibility of pregnant) or who are lactation. 13) Subjects who can not agree with preliminary explanation 14) Subjects who gained or lost 5% or more of weight within 6 month from the study 15) Subjects who are ineligible due to physician's judgment

Design outcomes

Primary

Measure	Time frame
Visceral fat area	—

Secondary

Measure	Time frame
Subcutaneous fat area, Total fat area, Body weight, BMI, Body fat percentage, Waist circumference, Intestinal flora, Fecal organic acid, Breath gas (O2, CO2)	—

Countries

Japan

Contacts

Public ContactToyotada Ashino

New drug research center, Inc. Clinical Research Dept.

t-ashino@ndrcenter.co.jp0123-34-0412

Outcome results