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Investigation on the anti-obesity effects of research food intake

Investigation on the anti-obesity effects of research food intake - Investigation on the anti-obesity effects of research food intake

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000054009
Enrollment
20
Registered
2024-03-29
Start date
2024-04-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adult male/female

Interventions

Consume 16 g/day of research food for 12 weeks

Sponsors

Metagen, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old. (2) 25=<BMI<30 kg/m^2 at informed consent. (3) Average number of steps per day is less than 10,000 steps. (4) No metal (pacemaker, etc.) in their body and are able to take CT scan. (5) Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study.

Exclusion criteria

Exclusion criteria: (1) Subjects who are unable to discontinue consumption of foods for specified health uses, foods with function claims, health foods (including supplements) that may affect the research (anti-obesity, lipid metabolism, appetite control, intestinal regulation, etc.) from the time consent is obtained. (2) Subjects who have taken drugs (antibiotics, antiflatulent, laxatives, etc.) that would affect the study one month prior to the pre-test. (3) Subjects who plan to take drugs that will affect the research during the study. (4) Subjects with a history of appendectomy. (5) Subjects who have undergone surgery that may affect the study (colonoscopy, removal of gallstones or gall bladder, gastric bypass surgery, bariatric surgery, etc.) within 6 months prior to obtaining consent. (6) Subjects undergoing dietary restriction or weight loss. (7) Subjects who plan to lose weight during the study. (8) Subjects who are expected to undergo a major change in their family, work, or other living environment (e.g., relocation, transfer, etc.) during the study. (9) Subjects with extremely irregular eating habits. (10) Subjects with special dietary habits (vegetarian, vegan, low-carbo). (11) Subjects whose roommates plan to participate in the study. (12) Smokers. (13) Heavy alcohol drinkers. (14) Subjects with previously diagnosed diabetes mellitus (type 1/type 2) or dyslipidemia. (15) Subjects with a history of serious diseases of the heart, liver, kidneys, digestive organs, etc. (16) Pregnant, lactating, or intending to become pregnant during the study. (17) Subjects allergic to medicines and foods. (18) Subjects who are aware of excessive abdominal symptoms (severe diarrhea or bloating) when ingesting oligosaccharides. (Due to character limitation, the following will be listed in the "Others" section)

Design outcomes

Primary

MeasureTime frame
Abdominal fat area

Secondary

MeasureTime frame
1. Gut microbiota 2. Gut metabolomes 3. Defecation status (frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, odor of defecation) 4. Abdominal symptoms (bloating, belching, gas) at times other than during defecation 5. Body weight, BMI, waist circumference, body composition 6. OSA-MA 7. POMS2 short version 8. GLP-1, PYY

Countries

Japan

Contacts

Public ContactFumiko Nakamura

CPCC Company Limited Clinical Support Division

cpcc-contact@cpcc.co.jp+81-3-6225-9001

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026