Effect of Skate Skin Extract on Body Fat in Overweight Adults: A RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Body fat percent
研究概览
简要总结
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults
详细描述
Our aim is to investigate the effect of oral ingestion of low-molecular collagen peptides derived from Skate Skin on body fat reduction in adults by a randomized, double-blind, and control-group study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 23~30 kg/m2
排除标准
- •Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
- •Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
- •Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
- •Those who are treated with hypothyroidism or hyperthyroidism
- •Creatinine levels: more than twice the normal upper limit
- •AST (GOT) or ALT (GPT) levels: more than twice the normal upper limit
- •Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
- •Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
- •Participated in the commercial obesity program within the last 3 months.
- •If you have participated or are planning to participate in another clinical trial within the past month If yes
- •Alcohol abuser
- •Smoking abstinence within 3 months
- •If they are pregnant or lactating or have a pregnancy plan during the clinical trial
- •Those with allergic reactions to the constituent food
- •Any person deemed inappropriate by the researcher for other reasons
研究组 & 干预措施
Skate Skin group
2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.
干预措施: Skate Skin group (Dietary Supplement)
Control group
2,000 mg of placebo was orally administered per day for 12 weeks.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Body fat percent
时间窗: Change from baseline body fat percent at 6, 12 weeks
Measured by DEXA
次要结局
未报告次要终点
研究者
Sang Yeoup Lee
Principal Investigator, Professor, Head of Integrated Research Institute for Natural Ingredients and Functional Foods (IRINIF)
Pusan National University Yangsan Hospital