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A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism -parallel-group, dose-comparison study-

A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism -parallel-group, dose-comparison study- - A study on the effect of continuous intake of the test food on body weight-related QOL and lipid metabolism

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000044860
Enrollment
20
Registered
2021-07-30
Start date
2021-08-28
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 one packet the test food (250 mg/packet) at once a day. Take two packets the test food (250 mg/packet) at once a day.

Sponsors

IMEQRD Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age between 30 to 59 years old. 2.Japanese males and females 3.Those who have high BMI. 4.Those who have defecation at least every day. 5.Those who can use smartphones or PC to record a diary. 6.Those who were given sufficient explanations of the trial information, and signed the document of the informed consent with well understanding for the trial objective; also, those who voluntarily joined the trial.

Exclusion criteria

Exclusion criteria: 1.Those who are currently given any medical treatment with drugs or traditional Chinese medications. 2.Those who have medical treatments such a diet therapy and/or an exercise therapy. 3.Those who had been experiencing a severe disease. 4.Those who have currently been taking yogurts, Lactobacillus containing beverages, or Lactobacillus containing foods and supplements, which have health claims, for being healthy. However, those who can discontinue taking these foods during the trial period after obtaining informed consent will be allowed to join the trial. 5.Those who have currently been taking drugs, quasi-drug products, or foods and supplements which have health claims for promoting metabolism, improving fatigue and stress, and reducing blood pressure. However, those who can discontinue taking these materials during the trial period after obtaining informed consent will be allowed to join the trial. 6.Those who have a drug allergy or a food allergy, or those who had been experiencing these diseases. 7.Heavy drinkers who drink over 60 g alcohol/day. 8.Those who have a smoking habit (over 21 cigarettes/day). 9.Those who are planning extremely change their lifestyle (such as diet, sleep, or exercise) during the trial period. 10.Those who work on night shift jobs and the shiftwork. 11.Those who are planning travels to foreign countries during the trial period. 12.Those who are currently pregnant or breastfeeding, or those who are planning to pregnant during the trial period. 13.Those who joined other clinical trials from 1 month before obtaining informed consent in this trial, or those who have currently been joined other clinical trials. Also, those who are planning to join other clinical trials. 14.Those who are unsuitable for this trial that judged by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Questionnaire for body weight-related QOL

Secondary

MeasureTime frame
Body mass, waist circumference, blood pressure, total cholesterol, HDL, LDL, triglycerides, insulin, fasting blood glucose, gut microbiota (16S rRNA-seq), free fatty acids

Countries

Japan

Contacts

Public ContactHirokuni Kayama

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