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Safety evaluation of the consumption of plant-derived processed product in healthy adults: a double-blind, randomized controlled trial with parallel group design.

Safety evaluation of the consumption of plant-derived processed product in healthy adults: a double-blind, randomized controlled trial with parallel group design. - Safety evaluation of plant-derived processed product

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000020271
Enrollment
30
Registered
2016-01-20
Start date
2016-01-24
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 subjects

Interventions

Control food(product code,C-002), administration period = 4 weeks, dosage = 30g/day Test food(product code,A-002), administration period = 4 weeks, dosage = 30g/day

Sponsors

New Drug Research Center, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -BMI>=22.0 and<30.0 kg/m2 -BMI>=20 and<65 years old -Person who provides inforrned consent by a document

Exclusion criteria

Exclusion criteria: 1) individual with liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases, 2) individual given surgery within 2 months before the trial, 3) medicine user for hyperglycaemia, lipidemia, or hypertension, 4) individual intakes supplements or the food for specific use of health authorized the government, 5) individual experienced unpleasant feeling during blood drawing, 6) individual donated 200 mL or more blood within 1 month before the trial, 7) individual changed his/her weight 2 kg or more within 1 month before the trial, 8) shiftworker, 9) individual plans bussiness trip for 10 consecutive days or more, 10) individual had allergy against any constituents in the test diet, 11) individual can not conform to alcohol limitation, 12) individual can not conform to record of daily life in a format, 13) individual can not conform to record of daily diet for 9 days (3 days x 3 times), 14) individual cannot allow operator to consult his/her data of the past health check, 15) individual have already participated other clinical trial and will participate, 16) individual cannot accept content of this trial, 17) pregnant women or breast-feeding women, 18) individual who was judged ineligibles by clinician in this trial

Design outcomes

Primary

MeasureTime frame
frequency of adverse events at 4 weeks after intervention.

Countries

Japan

Contacts

Public ContactShinpei Tomita

New Drug Research Center, Inc. Clinical Research Dept.

s-tomita@ndrcenter.co.jp0123-34-0412

Outcome results

None listed

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