None listed
Conditions
Interventions
Oral ingestion of a test food (1 packet in a day
12 weeks).
Oral ingestion of a placebo food (1 packet in a day
12 weeks).
Sponsors
TES Holdings Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Healthy men and women aged 20 to 64 at the time of obtaining consent to participate in the study. 2) Individuals with a BMI of 23.0 kg/m2 or higher but less than 30.0 kg/m2. 3) Individuals who have received a thorough explanation of the study's purpose and content, possess the capacity to consent, have voluntarily applied to participate after fully understanding the study, and are able to provide written consent to participate in the study. 4) Individuals who are able to visit the facility on the designated examination date and undergo the examination. 5) Individuals deemed suitable for participation in the study by the principal investigator.
Exclusion criteria
Exclusion criteria: Individuals 1) currently suffering from any medical condition and undergoing treatment. 2) with a current history of chronic fatigue syndrome, mental disorders, sleep disorders, hypertension, diabetes, or dyslipidemia, or a history of serious medical conditions. 3) with a current or past history of serious conditions affecting the liver, kidneys, heart, lungs, blood, or digestive system. 4) who have taken or applied medication for the treatment of a medical condition within the past month. 5) with non-removable metal implants in their bodies or who use a pacemaker. 6) who have donated blood or similar fluids in amounts exceeding 200 mL within the past month or 400 mL within the past three months. 7) who may experience allergic reactions to the test food, or who may experience allergic reactions to other foods or medications. 8) who have experienced significant weight changes (approximately 5% of body weight as a guideline) within three months prior to the start of this trial. 9) whose average weekly alcohol intake (in terms of pure alcohol) exceeds 40 g/day for men and 20 g/day for women. 10) who currently have, or have had within the past 3 months, a habit of regularly consuming health foods containing functional dietary fibers such as resistant dextrin or inulin, or who plan to consume such products during the study period. 11) who currently have, or have had within the past three months, a habit of regularly consuming foods for specific health uses, foods with functional claims, or health foods that claim to reduce body fat, or who plan to consume such products during the trial period. 12) whose lifestyle may change during the study period. 13) who are pregnant, breastfeeding, or who may become pregnant. 14) currently participating in another clinical trial, or those who have participated in another clinical trial within the past 3 months. 15) Any other individuals deemed unsuitable for this study by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement of Abdominal Visceral Fat | — |
Secondary
| Measure | Time frame |
|---|---|
| * Secondary Outcome Measures 1) Abdominal subcutaneous fat area 2) Total abdominal fat area 3) Body composition measurement 4) Waist circumference and hip circumference measurement / Waist-to-hip ratio 5) Brief Dietary History Questionnaire (BDHQ) 6) Subjective questionnaire survey 7) Lipid-related markers 8) Fecal IgA 9) Gut microbiota analysis 10) Specialized blood tests * Safety Assessment Items 1) Blood pressure/pulse 2) Hematological tests 3) Blood chemistry tests 4) Urinalysis 5) Physician interview/assessment of adverse events/confirmation of side effects 6) Daily activity log | — |
Countries
Japan
Contacts
Public ContactRyoma Shimizu
TES Holdings Co., Ltd. Administrative Department of Clinical Trials
Outcome results
None listed