Safety of Overconsumption of a Food Containing of Plant Extract

• Register: JPRN
• Last refreshed on: 17 October 2023
• Main ID: JPRN-UMIN000026686
• Date of registration: 24/03/2017
• Prospective Registration: Yes
• Primary sponsor: TES Holdings Co., Ltd
• Public title: Safety of Overconsumption of a Food Containing of Plant Extract
• Scientific title: Safety of Overconsumption of a Food Containing of Plant Extract - Safety of Overconsumption of a Food Containing of Plant Extract
• Date of first enrolment: 2017/03/27
• Target sample size: 36
• Recruitment status: Complete: follow-up complete
• URL: https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030564
• Study type: Interventional
• Study design: Parallel Randomized
• Phase: Not selected

Countries of recruitment

Japan

Contacts

• Name: Ryoma Shimizu
• Affiliation: TES Holdings Co., Ltd Administrative Department of Clinical Trials

• Name: Mamoru Oki
• Affiliation: Seishukai Medical Corporation Seishukai Hospital Head

Key inclusion & exclusion criteria

Inclusion criteria:
Exclusion criteria: [1]Individuals using medical products. [2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. [3]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis). [4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease. [5]Individuals who are a patient or have a history of or endocrine disease. [6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months. [7]Individuals who experienced unpleasant feeling during blood drawing. [8]Individuals who are sensitive to a test product or other foods, and medical products. [9]Individuals who habitually take the foods for specified health uses (FOSHU) or functional food. (Except for subjects who can stop consume them after informed consent). [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day). [11]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period. [12]Individuals who are or are possibly, or are lactating. [13]Individuals who participated in other clinical studies in the past 3 months. [14]Individuals who are or whose family is engaged in healthy or functional foods. [15]Individuals judged inappropriate for the study by the principal.

Age minimum: 20years-old
Age maximum: 65years-old
Gender: Male and Female

Health Condition(s) or Problem(s) studied

N/A(healthy adults)

Intervention(s)

Oral intake of the test product (containing plant extract; 300mL in a day for 4 weeks)
Oral intake of the placebo product (not containing plant extract; 300mL in a day for 4 weeks)

Primary Outcome(s)

[1]Existence and its contents of side effects: expression number and expression rate of side effects (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 2, Week 4)

Secondary Outcome(s)

*Secondary outcomes [1]Adverse events: number of cases and expression rate of adverse events (expression rate: number of cases/number of cases analyzed) (SCR, Week 0, Week 2, Week 4) [2]Blood pressure, pulsation (SCR, Week 0, Week 2, Week 4) [3]Weight, body fat percentage, BMI (SCR, Week 0, Week 2, Week 4) [4]Hematologic test (SCR, Week 0, Week 2, Week 4) [5]Blood biochemical test (SCR, Week 0, Week 2, Week 4) [6]Urine analysis (SCR, Week 0, Week 2, Week 4) [7]Doctor's questions (SCR, Week 0, Week 2, Week 4) *Other index [1]Subject's diary (each day during the test period)

Source(s) of Monetary Support

Ogawa & Co., Ltd

Ethics review

Status: YES
Approval date:
Contact: