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

Not Applicable

• Conditions: Healthy Adult

• Registration Number: JPRN-UMIN000016455
• Lead Sponsor: ew drug research center, Inc.

Brief Summary

There was a significant difference in primary outcome

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-03-31
• Study Completion: 2016-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified