A health monitoring study of healthy meal intake in Japanese adults with level 1 or higher obesity level of the criteria by Japan Society for the Study of Obesity - A health monitoring study of healthy meal intake in Japanese adults with level 1 or higher obesity level of the obesity criteria
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- InCROM Inc.
- 入组人数
- 30
研究概览
简要总结
<Results> This study started on October 3, 2016 and ended on December 22, 2016. Out of 31 subjects who gave informed consent, 30 subjects completed the study excluding 1 subject with BMI > 25. The number of subjects was 15 each for male and female. The means +/- SDs of age, height, weight and BMI of the subjects were 45.2 +/- 9.9 years, 163.88 +/- 7.66 cm, 76.50 +/- 12.54 kg, and 28.34 +/- 3.74. Those of female subjects were 44.7 +/- 9.9 years, 157.70 +/- 4.08 cm, 71.77 +/- 13.33 kg, and 28.72 +/- 4.66. Those of male subjects were 45.7 +/- 10.1 years, 170.06 +/- 4.8 cm, 81.23 +/- 10.00 kg, and 27.97 +/- 2.64. The means +/- SDs of BMI, which was the primary endpoint in this study, at pre-study food intake, at post-2weeks, and at post-4 weeks of study food intake were 28.34 +/- 3.74, 27.42 +/- 3.66, and 26.80 +/- 3.59, respectively. Those of females were 28.72 +/- 4.66, 27.83 +/- 4.64, 27.27 +/- 4.54, and those of males were 27.97 +/- 2.64, 27.01 +/- 2.43, and 26.33 +/- 2.38. The statistical test indicated that BMI significantly decreased at post-2 weeks and 4 weeks of study food intake (p<0.0001 each). The mean +/- SD of body weight, which was the secondary endpoint, at pre-study food was 76.50 +/- 12.54 kg, whereas those at post-2 weeks and 4 weeks of study food intake were 73.82 +/- 12.16 kg and 72.19 +/- 11.85 kg. In female subjects, that at pre-study food was 71.77 +/- 13.33 kg, whereas those at post-2 weeks and 4 weeks of study food intake were 69.42 +/- 13.15 kg and 68.11 +/- 12.85 kg. In male subjects, that at pre-study food was 81.23 +/- 10.00 kg, whereas those at post-2 weeks and 4 weeks of study food intake were 78.23 +/- 9.57 kg and 76.27 +/- 9.49 kg. Refer to statistical analysis report for details of statistical analysis results.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 65years-old(—)
- 性别
- All
入选标准
- 未提供
排除标准
- •1. The subject who has hepatic, renal, cardiovascular, respiratory, endocrine system, metabolic, neurological, or psychiatric disorder, or who was assessed to have a past history of any of these diseases by the principal investigator or subinvestigators (excluding subjects with lifestyle related diseases including hypertension, dyslipidemia, or diabetes mellitus who were assessed eligible for this study by the principal investigator) 2. The subject who has drug or food allergy 3. The subject who has drug or alcohol dependence 4. In addition, the subject who was assessed ineligible for the study by the principal investigator or subinvestigators
