Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage - Randomized placebo-controlled double-blind parallel group comparison study -

Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage - Randomized placebo-controlled double-blind parallel group comparison study - - Study on abdominal visceral fat reducing action by indigestible dextrin-containing tea beverage

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032508

Enrollment

140

Registered

2018-05-08

Start date

2018-04-16

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(350mL)of 3 bottles of test beverage per day for 12 weeks Intake of placebo food(350mL)of 3 bottles of test beverage per day 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 old 2 Subjects with equal to or more than 23 and less than 30 kg/m^2 of BMI at the 1st screening test

Exclusion criteria

Exclusion criteria: 1 Subjects who received medication treatment or surgery due to serious illness or injury within 1 months from the start of this study 2 Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 3 Subjects who medicine for glycometabolism, lipidmetabolism, or reducing high blood pressure 4 Subjects who regularly use over-the-counter medicine, health foods, supplements which are suggested causal relationship from the screening test 5 Pregnant and lactating female, or who wish to get pregnant during the study period 6 Heavy drinkers 7 Individual donated 400 ml of blood within 12weeks or component blood donation 200 ml of blood within 4weeks prior to the study 8 Subjects who are planned to change their life style or maitain irregular life during study period 9 Subjects who cannot follow test sample intake condition by the protocol 10 Subjects already participating in other clinical trials, subjects planning to participate during this examination period 11 Subjects who are ineligible due to physician's judgment

Design outcomes

Primary

Measure	Time frame
Efficacy Visceral fat area	—

Secondary

Measure	Time frame
Efficacy Total fat area, subcutaneous fat area, body weight, BMI, Triglycerides, glycometabolism relation items Safety Side effect incidence,Adverse event incidence, clinical examination items excluding efficacy evaluation items, and physiological examination items excluding efficacy evaluation items	—

Countries

Japan

Contacts

Public ContactYoshitaka Hatakeyama

New Drug Research Center, Inc. Clinical Research Dept.

y-hatakeyama@ndrcenter.co.jp0123-34-0412

Outcome results