Healthy adults
Conditions
Interventions
Ingestion of test food, 1 sachet daily for 16 weeks
Ingestion of placebo food, 1 sachet daily for 16 weeks
Sponsors
IMEQRD Co. Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Healthy adults aged 20 to under 60 at consent 2.BMI >=23 and <30 kg/m^2 3.Abdominal visceral fat area >=70 cm^2 at screening 4.Able to enter electronic diaries via PC or smartphone 5.Fully informed of study purpose and procedures, able to consent, and voluntarily agreed in writing
Exclusion criteria
Exclusion criteria: 1 Currently receiving treatment for any disease with medication or Kampo (as-needed use permitted) 2 Under treatment for obesity, hyperlipidemia, lipid metabolism, or intestinal regulation 3 On physician-supervised diet or exercise therapy 4 Currently dieting or planning to start during study 5 History or presence of serious disease 6 History of gastrointestinal surgery (except appendectomy) 7 Currently taking products affecting obesity, hyperlipidemia, lipid metabolism, including quasi-drugs, FOSHU, functional foods, health foods, or supplements (eligible if discontinued after consent) 8 Currently taking other quasi-drugs, FOSHU, functional foods, health foods, or supplements (eligible if discontinued after consent) 9 Used antibiotics within 1 month before consent or plans to use during study 10 Plans for endoscopy, barium exam, H. pylori eradication, or tooth extraction during study 11 Unable to abstain from alcohol the day before testing 12 History or presence of food or drug allergies 13 >=40 g pure alcohol/day 14 >=21 cigarettes/day 15 Shift workers with night shifts 16 Plans for extended travel or major lifestyle changes during study 17 Tendency toward constipation or diarrhea 18 Unable to discontinue health foods for constipation during study 19 Unable to discontinue probiotics, prebiotics, or supplements containing live bacteria or oligosaccharides during study 20 Currently taking tryptophan supplements (eligible if discontinued after consent) 21 Currently taking protein powders or drinks (eligible if discontinued after consent) 22 Judged by investigator to have impaired renal function 23 Presence of metal implants from surgery 24 Use of pacemaker or implantable medical device 25 Claustrophobia 26 Pregnant, breastfeeding, or planning pregnancy during study 27 Participation in another clinical trial or within 4 weeks after completion, or plans to participate after consent 28 Judged by investigator to be otherwise unsuitable for study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Abdominal visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| - Height, weight, BMI, body composition - Waist circumference - Abdominal subcutaneous fat area, total abdominal fat area - Gut microbiota - AST, ALT, fasting blood glucose, HbA1c - Blood metabolite levels: tryptophan, indole-3-propionic acid, other tryptophan metabolites - Intestinal barrier function: serum zonulin, serum LBP - Oxidative stress marker: urinary 8-OHdG - Skin questionnaire - Brief-type self-administered diet history questionnaire | — |
Countries
Japan
Contacts
Public ContactHirokuni Kayama
IMEQRD Co., Ltd. Planning and Sales Department
Outcome results
None listed