Healthy and overweight adult subjects between 23 or more and less than 30 in body mass index (BMI)
Conditions
Interventions
Ingestion of supplement containing fucose for 20 weeks.
Ingestion of placebo without fucose for 20 weeks.
Sponsors
KSO Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy males and females aged 20 to 64 years old 2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI 3. Subjects with subjective symptoms of chronic constipation 4. Subjects who can make self-judgment and are voluntarily giving written informed consent
Exclusion criteria
Exclusion criteria: 1. Subjects who use medications affecting obesity and constipation 2. Subjects who cannot stop using supplements and/or functional foods affecting obesity and constipation 3. Subjects who are under treatment or have a history of disease e.g., serious liver disease, heart disease, respiratory insufficiency, endocrine disorder, metabolic diseases or food allergy 4. Subjects who have under treatment or a history of drug addiction and/or alcoholism 5. Subjects who have implanted metal in the abdominal area, as detected by computerized tomography 6. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 7. Subjects who have been diagnosed as familial hyperlipidemia 8. Subjects who has food allergy 9. Subjects who are participating or planning to participate in other clinical studies to examine effects of food, medicine or cosmetics 10. Subjects who are planning to become pregnant during the study or are pregnant or lactating 11. Subjects who are judged as unsuitable for the study by the investigator for other reasons
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visceral fat area *Assess the fat area by X-ray CT | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Subcutaneous fat area 2. Total fat area 3. Visceral fat area 4. Subcutaneous fat area 5. Total fat area 6. Waist and Hip circumference 7. Body weight 8. Defecation frequency 9. Bristol stool scale *1-2 Assess these by X-ray CT *3-5 Assess these by Bioelectrical impedance analysis | — |
Countries
Japan
Contacts
Public ContactEiji Yoshikawa
KSO Corporation Sales department
Outcome results
None listed