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Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study-

Study on evaluation of reduction effect of test supplement on body weight -a randomized, double blind, placebo controlled, parallel group comparison study- - Body weight reduction effect of test supplement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000037107
Enrollment
100
Registered
2019-06-20
Start date
2019-07-01
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

Sponsors

HUMA R&D CORP
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese male and female whose age is between 45 and 70 years old. 2. Subjects whose BMI is between 23 and 30. 3. Subjects who can understand the aim of this study and have the competency for giving consent.

Exclusion criteria

Exclusion criteria: 1 Subjects who currently are dieting 2 Subjects who have some metal which the abdomen cannot remove 3 Subjects who have bolt in lumbar spine 4 Subjects who have stoma 5 Subjects who plan the examination with barium within one week before each examination day after screening test step 2 6 Subjects who are currently under medical treatment 7 Subjects who are currently under exercise and dietary treatment 8 Subject who have an allergy against trial supplement 9 Subjects who have current disease or history of drug and/or alcoholism 10 Subjects who have current treatment or history of mental disorder and/or sleep disorder 11 Subjects who are night shift or shift workers 12 Subjects with extremely irregular lifestyles such as food and sleep 13 Subjects who have an extreme unbalanced diet 14 Subjects who have serious disease or history 15 Subjects who use health foods, supplements and medicines that affect weight and lipid metabolism 16 Subjects who participated in other clinical trials within one month from the date of obtaining consent, or who plan to participate in other clinical trials during the trial period 17 Subjects who carried out blood collection, component blood donation more than 400 mL within 200 mL or 3 months within one month going back from the date of consent acquisition 18 Females who are known or suspected to be pregnant, breastfeeding or desire to become pregnant during the trial period. 19 Subjects who have a habit of taking a food containing a large amount of lactic acid bacteria for 3 days or more a week 20 Subjects who always use a laxative for defecation 21 Subjects who used probiotics, antibiotics 22 Subjects who have difficulty in keeping records on various questionnaires 23 Subjects who have difficulty in keeping records on various questionnaires 24 Subjects who are judged as unsuitable for the study by the investigator for other reason

Design outcomes

Primary

MeasureTime frame
Body weight

Secondary

MeasureTime frame
Abdominal visceral fat area, abdominal total fat area, abdominal subcutaneous fat area, BMI, body fat percentage, waist circumference, hip circumference, ratio of waist and hip circumferences, subgroup analysis (BMI, abdominal visceral fat area, sex, defecation frequency)

Countries

Japan

Contacts

Public ContactDaisuke Ochitani

HUMA R&D CORP Clinical Development Division

ochitani@huma-rd.co.jp03-3431-1260

Outcome results

None listed

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