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Safety evaluation study of excessive intake beef cooked with soy sauce containing Salacia extract in adult men and women.

Safety evaluation study of excessive intake beef cooked with soy sauce containing Salacia extract in adult men and women. - Safety evaluation study of excessive intake of food containing plant extract in adult men and women.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026089
Enrollment
30
Registered
2018-03-06
Start date
2017-03-06
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

Intake of test food for 4 weeks, everyday Intake of placebo food for 4 weeks, everyday

Sponsors

QOL RD Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Healthy subjects aged from 20 to 64 years-old at the time of giving informed consent 2.Subjects whose fasting blood glucose is less than or equal to 125mg/dl at the time of giving informed consent 3.Subjects having no dietary restriction 4.Subjects neither attending the hospital as outpatients nor medicated 5.Subjects without serious liver disorder, renal disturbance, heart disease, cerebrovascular disease, organ derangement and allergic disease 6.Subjects who fully understand and agree with the objective of this study by prior oral explanation and are able to give informed consent written by themselves

Exclusion criteria

Exclusion criteria: 1.Subjects having allergies for drugs and foods 2.Subjects who drink alcohol more than in terms of 500ml beer in a day. 3.Subjects who smoke more than 20 cigarettes on average in a day 4.Pregnant women, or women intending to be pregnant, and lactating women 5.Subjects who donated more than 200ml of blood within 1 month or more than 400ml of blood within 3 months prior to the study 6.Subjects who are participating in the other clinical trial 7.Subjects who don't follow the instructions from the doctor or the staff

Design outcomes

Primary

MeasureTime frame
Incidence of side effect

Countries

Japan

Contacts

Public ContactHitomi Nasu

QOL RD Co.,Ltd. CRO Department Food Division

h-nasu@qol-rd.co.jp03-6386-8809

Outcome results

None listed

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