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A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverage containing plant extract (Ex.no.14154)

A double-blind, randomized, placebo-controlled clinical trial to investigate the effect of the beverage containing plant extract (Ex.no.14154) - A clinical trial to investigate the effect of the beverage containing plant extract

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000016455
Enrollment
140
Registered
2016-03-31
Start date
2015-02-06
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 Adult

Interventions

Food containing plant extract for 12 weeks Food without plant extract for 12 weeks

Sponsors

New drug research center, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Healthy males and females equal to or more than 25kg/m^2 and less than 30kg/m^2 of BMI

Exclusion criteria

Exclusion criteria: 1)Subjects with a history of allergy to medicine and food 2)Subjects who have serious historical disease or have marked impairment of heart, lung,liver, kidney, heart, or gastrointestinal tract functions (excluding extirpation of vermiform appendix). Subjects who have above one relevance to the following conditions 1.TG is above 400 mg/dL 2.total-cholesterol is above 300 mg/dL 3.Fast Blood Glucose is above 126 mg/dL and HbA1c(NGSP)is above 6.5 % 4.AST(GOT)is above 100 U/L 5.ALT(GPT)is above 100 U/L 6.gamma-GTP is above 200 U/L 7.Hemoglobin is below 11.9 g/dL(male), 10.9 g/dL(female) 8.Creatinine is below 1.30 mg/dL(male), 1.00 mg/dL(female) 9.Subjects who don't empty the bowels more than 3 days, or who feel a sense of incomplete evacuation even if who empty the bowels every day 3)Subjects who donated 400 mL of blood within 12 weeks before starting of administration, or who donated 200 mL of blood within 4 weeks or donated blood component within 2 weeks 4)Subjects with systolic blood pressure under 90 mmHg 5)Subjects who smoke excessively and drink alcohol habitually 6)Subjects whose eating habits are extremely irregular or who are midnight and irregular shift workers 7)Subjects who regularly use medicine (depressor drugs, hypolipidemic agents, hypoglycemic drugs, polyene phosphatidylcholine, linoleic acid derivatives, clofibrate, nicomol, unsaponified soybean oil, elastase, artoron, probucol, cholestyramine, HMG-CoA reductase inhibitor, anorexiant drug, etc.), Food for Specified Health Uses, special health-promoting foods known to alter this trial. 8)Subjects who plan to become pregnant, who are during pregnancy, or who are nursing 9)Subjects who participate in other clinical trials or whose participation finishes within 4 weeks prior to the current clinical trial 10)Subjects who are ineligible due to physician's judgment

Design outcomes

Primary

MeasureTime frame
Visceral fat area before intake ,at 8, 12 weeks after intake

Secondary

MeasureTime frame
Total fat area, subcutaneous fat area, body weight, BMI, body fat ratio, waist size measurement, hip size measurement, skinfold thickness measurement

Countries

Japan

Contacts

Public ContactYuji Matsui

Kao Corporation Biological Science Research

Matsui.yuji@kao.com+81-3-5630-7268

Outcome results

None listed

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