Effects of consumption of the test food on body fat: 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: Active capsule Dose and Administration: Take one capsule per day after breakfast with water or lukewarm water * If you forget to take the capsule, take it as soon as you remember within the day. Duration: 12 weeks Test material: Placebo capsule Dose and Administration: Take one capsule per day after breakfast with water or lukewarm water * If you forget to take the capsule, take it 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. Body weight; 5. Body mass index; 6. Body fat percentage; 7. Lean body mass; 8. Muscle mass; 9. Abdominal circumference; 10. Basal metabolic rate; 11. Abdominal obesity ratio; ; *1‐3 Assess these by X‐ray CT; *1‐11 Conduct these at screening (before consumption) and 4, 8, and 12 weeks after consumption. INCLUSION CRITERIA: 1. Japanese adult subjects 2. Subjects who are between 23 kg/m2 or more and less than 30 kg/m2 in BMI 3. Subjects who are judged as eligible to participate in the study by the physician 4. Within the subjects who met the 1st to 3rd inclusion criteria, subjects whose visceral fat area assessed by X‐ray CT are relatively large
Epistemonikos ID: ff66740b0abdc3241a3773db1c640398cff6fe34
First added on: Aug 24, 2024