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A study of the effect of continuous intake of test food on fat metabolism and other state of human body. - randomized, placebo-controlled, double-blind, parallel-group trial -

A study of the effect of continuous intake of test food on fat metabolism and other state of human body. - randomized, placebo-controlled, double-blind, parallel-group trial - - A study of the effect of continuous intake of test food on fat metabolism and other state of human body.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000048342
Enrollment
60
Registered
2022-07-12
Start date
2022-08-09
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 adults

Interventions

Take test food A with water or warm water for 12 weeks. Take test food B with water or warm water for 12 weeks. Take placebo food with water or warm water for 12 weeks.

Sponsors

IMEQRD Co., Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Those who are aged between 20 and 65 years at the time of informed consent 2. Japanese males or females 3. Those who have no history of smoking within a year 4. Those who can record the electronic diary using smartphones or PCs. 5. BMI less than 30.0 kg/m2. 6. Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement

Exclusion criteria

Exclusion criteria: 1. Those who have been currently visiting a hospital or treated with any drug or herbal remedy for any disease 2. Those who are on diet / exercise therapy under the guidance of a doctor 3. Those who currently have or have history of severe diseases 4. Those who daily use machines or take medicine, quasi-medicine, food for specified health uses or nutritional supplements / foods on the market that have health claims related to fatigue, stress relief, cold intolerance, blood pressure, glycemia, or fat 5. Those who daily have drinks and foods contains bellows (excluding individuals who can refrain from ingestion after receiving informed consent until the end of the study) - any part (extract, pulp or peel) of citrus fruits such as mandarins, lemons, grapefruits and sudachis - any kinds of herb 6. Those who currently have or have a history of drug and/or food allergies 7. Those who are engaged in night work or spilt shift 8. Those who routinely take alcohol more than 60 g/day 9. Those who have unstable menstrual cycle or those who have prospect to have menstruation on the test date 10. Those who have habits of daily exercise such as jogging and muscle training 11. Those who have plans of major change on their lifestyle (e.g., diet, sleep and exercise) during the study period 12. Those who are planning to travel abroad during the study period 13. Those who are currently pregnant, breastfeeding or planning to get pregnant during the study period 14. Those who joined other clinical trials within 1 month before receiving informed consent in this study, or those who are currently joining other clinical trials 15. Those who are judged by the physician to be unsuitable for this study

Design outcomes

Primary

MeasureTime frame
lipid metabolism related tests body fat related tests swelling skin color blood test QoL questionnaire

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd Planning and Sales Department

clinical-trial@imeqrd.co.jp03-6704-5968

Outcome results

None listed

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