Influence of Herb With Alpha-glucosidase Properties (Salacia Chinensis) on Appetite, Glucose and Hormonal Factors: A Double Blind Randomized Placebo Controlled-crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Appetite ratings (VAS) at either dose compared to placebo compared to placebo)
研究概览
简要总结
The purpose of this study is to determine whether an herb with known alpha-glucosidase inhibitor properties (Salacia Chinensis, SC), affects postprandial appetite ratings and glucose indices in overweight/obese individuals.
详细描述
Subjects are randomly assigned (double blinded) to 300 mg SC, 500 mg SC or placebo using a cross-over design on three different days (1 month wash out). Subjects consuming a capsule containing placebo or treatment(s) are examined before and after a fixed breakfast meal (50% carbohydrate; 30% fat; 20% protein).
Subjective appetite sensations are rated using visual analog scales (VAS) for hunger, satiety, fullness, and prospective food intake. In addition, the desire for specific tastes is analyzed and measurements are taken twice before breakfast (fasting baseline). After baseline screening and blood draw, postprandial appetite and taste perception ratings and blood will be obtained at multiple time points during the 3 hour postprandial period (30, 60, 90, 120,180 min). Blood will be analyzed for glucose/insulin, gut peptides, and other markers in response to the meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI - overweight or stage 1 obesity
- •Must be willing and able to visit the geographic vicinity of New Brunswick, NJ
排除标准
- •(BP) [systolic BP> 140 and/or diastolic BP> 90]
- •Fasting blood glucose >126
- •Subject has a significant history or current presence of treated or untreated bleeding disorder, diabetes mellitus, thyroid disease, tachyarrhythmia, heart disease, kidney disease, or liver disease.
- •History of chronic conditions and on prescription medication, surgery and or any treatment
- •Any significant GI condition that would severely interfere with the evaluation of the study product including but not limited to inflammatory bowel disease (Ulcerative Colitis or Crohn's), history of frequent diarrhea, history of surgery for weight loss (including gastric bypass or lapband), history of perforation of the stomach or intestines, gastroparesis, clinically important lactose intolerance
- •History or presence of all cancers in the prior two years.
- •Participation in a clinical study with exposure to any registered and non-registered drug product within 30 days prior.
- •Pregnant or lactating women.
- •Subjects who are currently on any weight loss diets, weight loss regimen
- •Subjects currently taking prescription medication for hypertension, cardiovascular disease, diabetes and/or other chronic conditions.
- •Subject currently suffers from a sleep disorder and/or has a known history of (or is currently being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s), which in the opinion of the investigator, might put the subject at risk and/or confound the results of the study.
- •Subject has a known allergy or sensitivity to any ingredient in the test product.
- •Subject has any medical condition or uses any medication, nutritional product, dietary supplement or program, which in the opinion of the investigator, might interfere with the conduct of the study or place the subject at risk.
- •Subject has a history of difficulty swallowing large pills or tablets.
- •Investigator is uncertain about subject's capability or willingness to comply with the protocol requirements.
研究组 & 干预措施
300mg SC
300 mg Salacia Chinensis (SC). This will be compared to placebo.
干预措施: 300 mg SC (Dietary Supplement)
500mg SC
500 mg Salacia Chinensis (SC). This will be compared to placebo.
干预措施: 500 mg SC (Dietary Supplement)
Placebo
The investigators will examine subjects before and during a 3 hour period after subjects consume a Placebo capsule and a fixed breakfast meal.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Appetite ratings (VAS) at either dose compared to placebo compared to placebo)
时间窗: Change from Baseline and 3 hours
Visual analog scale (VAS)
次要结局
- Taste perception (dose compared to placebo)(Change from Baseline and 3 hours)
- Glucose indices (at either dose vs placebo)(Change from Baseline and 3 hours)
研究者
Sue A. Shapses, Ph.D., RD
Professor
Rutgers University