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A study on the effect of continuous intake of test food on body composition in mildly obese adults - A randomized, placebo-controlled, double-blind, fixed-dose, parallel-group comparative trial -

A study on the effect of continuous intake of test food on body composition in mildly obese adults - A randomized, placebo-controlled, double-blind, fixed-dose, parallel-group comparative trial - - A study on the effect of continuous intake of test food on body composition in mildly obese adults

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000053920
Enrollment
75
Registered
2024-03-23
Start date
2024-03-24
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 adults

Interventions

Intake of test food A with water or lukewarm water, 1 tablet at a time, once a day after dinner, for 12 weeks. Intake of test food B with water or lukewarm water, 1 tablet at a time, once a day after

Sponsors

IMEQRD Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Age: 20 or more, and under 65 2. Mele or female 3. BMI 23.0kg/m^2 or more, and under 30.0kg/m^2 4. Subjects who can use smartphones or PC to record a digital diary 5. Subjects who received a sufficient explanation for the study objective, and voluntarily joined the study with the agreement to informed consent

Exclusion criteria

Exclusion criteria: Subjects -- 1. currently receiving medical treatment with any drugs, except required single-use 2. receiving a diet therapy or physiotherapy under medical supervision 3. continuously taking quasi-medicine, food for specified health uses (FOSHU), foods with functional claim, or nutritional supplements / foods that affect obesity, hyperlipidemia, lipid metabolism, or hypertension, in three months before informed consent. 4. daily (4 or more times a week) taking quasi-medicine, FOSHUs, foods with functional claim, nutritional supplements / foods other than criteria 3. 5. regularly (4 or more times a week) taking foods rich in lactic acid bacteria 6. who have received weight loss treatment or have attended a beauty salon or gym within 1 year before informed consent 7. disable to stop drinking liquor on the day before the inspection date 8. who currently have or have a history of severe diseases 9. who had a gastrointestinal operation (except appendicitis) 10. who currently have or have a history of food/drug allergies 11. who currently have or have a history of alcoholism or drug addiction 12. who have metal parts inserted into their bodies due to surgery 13. using cardiac pacemaker or with implantable devices in their bodies 14. who have claustrophobia 15. taking alcohol more than 40 g/day 16. with excessive daily smoking: 20 or more cigarettes a day 17. working night shift 18. having plans of major change on their lifestyle(e.g., diet, sleep, and exercise) during the study period 19. planning to travel abroad during the study period 20. currently pregnant, breast-feeding or planning to get pregnant during the study period 21. who received positive test result after infectious disease testing at a start of the trial 22. who have participated another clinical study or have ingested test foods for other trials within 1 month. 23. judged by the physician to be unsuitable for this study

Design outcomes

Primary

MeasureTime frame
Body weight, BMI, Body fat percentage

Secondary

MeasureTime frame
Abdominal fat area (Visceral fat area, Subcutaneous fat area, Total fat area), Waist circumference, Plasma acetate, Mood 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