Effects of consumption of the test food in healthy Japanese normal to overweight subjects: a randomized, double-blind, placebo-controlled, parallel-group trial

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2018
INTERVENTION: Duration: 12 weeks Test material: Capsules containing an enzyme Dose: Take 2 capsules per day Administration: Take 2 capsules after breakfast * If you forget to take capsules, take these as soon as you remember within the day. Duration: 12 weeks Test material: Placebo capsule Dose: Take 2 capsules per day Administration: Take 2 capsules after breakfast * If you forget to take capsules, take these as soon as you remember within the day. CONDITION: Japanese subjects between 23 kg/m2 or more and less than 30 kg/m2 in body mass index (BMI) PRIMARY OUTCOME: The visceral fat area in a cross section of the umbilical region ; ; * Assess the fat area by X‐ray CT ; * Calculate the amount of change between screening (before consumption) and 12 weeks after consumption SECONDARY OUTCOME: 1. Total fat area; 2. Subcutaneous fat area; 3. Visceral fat area; 4. Serum adiponectin level; 5. Serum total cholesterol level; 6. Serum HDL‐cholesterol level; 7. Serum LDL‐cholesterol level; 8. Serum neutral fat (TG: triglyceride) level; 9. Serum glucose level; 10. Height; 11. Body weight; 12. Body mass index; 13. Body fat percentage; 14. Body temperature; 15. Abdominal circumference; 16. Muscle mass; 17. Basal metabolic rate; 18. Subjective symptoms (A questionnaire); ; *1‐9, 11‐18 Assess these tests at screening (before consumption) and at 12 weeks after consumption; *10 Measure the height only at screening (before consumption); *1‐2 Assess these by X‐ray CT. Measure the fat area of umbilicus cross section and calculate the amount of change between screening (before consumption) and 12 weeks after consumption.; *3 Assess the measured value of the fat area in a cross section of the umbilical region by X‐ray CT.; *4‐9, 11‐17 Measure the items and calculate the amount of change between screening (before consumption) and 12 weeks after consumption.; *18 Assess symptoms by the Likert scale. Each item is assessed with a six‐point grading scale from 1 (strongly disagree) to 6 (strongly agree). The smaller number indicates better condition. INCLUSION CRITERIA: 1. Japanese adult subjects between 23 kg/m2 or more and less than 30 kg/m2 in BMI 2. Subjects who are judged as eligible to participate in the study by the physician 3. Within the subjects who met the 1st and 2nd inclusion criteria, subjects whose visceral fat area of umbilicus cross section are relatively large
Epistemonikos ID: e1b7dff25061e3a0d80f632113894c7ff625c762
First added on: Aug 24, 2024