Randomized, Placebo-controlled, Clinical Study to Investigate the Anti-Metabolic Syndrome Effect of the Functional Food in humans

Randomized, Placebo-controlled, Clinical Study to Investigate the Anti-Metabolic Syndrome Effect of the Functional Food in humans - Box Lunch Study at Kanagawa Prefecture

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019041

Enrollment

160

Registered

2015-09-16

Start date

2015-09-09

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

Obesity

Interventions

The subjects take the test food(rice) during 12 weeks (non-holiday). The subjects take the test food(Japanese tea) during 12 weeks (non-holiday). The subjects take the test food(Side dish) during 12

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Aged 20-65 years at informed consent 2) Visceral fat area >=100cm2 for male, >=80cm2 for female 3) Body-mass index (BMI) 25-30 kg/m2 for male, 23-30 kg/m2 for female 4)Fasting blood glucose =<125mg/dL 5) Obtained written informed consent from the subjects for the study participation

Exclusion criteria

Exclusion criteria: 1) Pregnancy, nursing or planning to become pregnant during the study (female only) 2) Any other significant medical conditions 3) Uncontrolled metabolic syndrome, or diabetes with insulin treatment 4) Severe allergies to wheat, soy, egg, milk, crustacean shellfish 5) Severe sensitivity to caffeine 6) Implantable electronic medical devices 7) Wearable electronic medical devices 8) Mechanical life support equipment 9) Metals as implantable materials 10) Dialysis patients 11) Participation in other clinical trials at enrollment 12) Any other considered by a study physician to be inappropriate for inclusion

Design outcomes

Primary

Measure	Time frame
Visceral fat area The start of the test after 6 weeks, 12 weeks after the start of the test	—

Countries

Japan

Contacts

Public ContactHidekazu Saito

Not-for profit Organization Japan Clinical Research Support Unit Clinical Research Department

bento@crsu.org03-5842-7480

Outcome results

None listed

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