NCT02322294已完成2 期
A Double-Blind, Placebo-Controlled, Parallel Study to Investigate the Effects of 8 Weeks Use of Glucodia™ on Glucose Parameters, Triglycerides and Body Weight as Compared to Placebo
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in glucose response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo
研究概览
简要总结
This study is investigating the effects of 8 weeks of supplementation with Glucodia™, on glucose parameters, triglycerides and body weight as compared to a placebo. Half of the subjects will be administered Glucodia™, while the other half will receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female adults, aged 21 to 45 years
- •BMI of 25 kg/m2 to 40 kg/m2 (inclusive)
- •Subjects with Fasting Plasma Glucose 5.56mmol/L to 6.94mmol/L (100mg/dL-125mg/dL) AND EITHER Fasting Insulin 60 pmol/L to 180 pmol/L OR Triglycerides 1.36mmol/L to 3.39 mmol/L (120mg/dL-300mg/dL)
- •Subject is not of child bearing potential. Defined as females who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with > 1 year since last menstruation).
- •OR Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include: Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System), Double-barrier method (condoms with spermicide or diaphragm with spermacide), Non-hormonal intrauterine devices, Vasectomy of partner, Non-heterosexual lifestyle
- •Subjects who have no plans to change their smoking habits during the trial period.
- •Subjects who are normally active and are deemed to be healthy by the Medical Director
- •Subjects who agree to maintain their current level of activity throughout the trial period.
- •Subjects who agree to maintain their current dietary habits throughout the trial period.
- •Subjects who have given voluntary, written, informed consent to participate in the study.
排除标准
- •Subjects who are pregnant, breastfeeding or planning on becoming pregnant throughout the course of the study.
- •Subjects with Fasting Glucose < 5.56 mmol/L or > 6.94 mmol/L
- •Subjects with Fasting Plasma Glucose 5.56 mmol/L to 6.94 mmol/L who DO NOT have EITHER Fasting Insulin 60 pmol/L to 180 pmol/L OR Triglycerides 1.35 mmol/L to 3.39 mmol/L
- •Subjects with BMI < 25 kg/m2 or > 40 kg/m2
- •Subjects who have experienced weight loss or gain of greater than 4.5 kg (approximately 10 lbs) in the past 3 months
- •Subjects with uncontrolled hypertension ( ≥ 140 mmHg)
- •Subjects with any major diseases of the cardiovascular, renal, hepatic, gastrointestinal, pulmonary or endocrine systems
- •History of or current diagnosis of any cancer (except for successfully treated basal cell carcinoma) diagnosed less than 5 years prior to screening. Subjects with cancer in full remission more than 5 years after diagnosis are acceptable
- •Subjects with neurological disorders or significant psychiatric illnesses
- •Subjects with unstable thyroid disease
- •Subjects who are immuno-compromised (HIV positive, on anti-rejection medication, rheumatoid arthritis)
- •Subjects who have taken any medication or natural health products intended for the management of diabetes, dyslipidemia or body weight within 3 months of randomization.
- •Subjects who use illicit drugs or have a history of alcohol or drug abuse within the past 6 months
- •Subjects who currently consume greater than 2 standard alcoholic drinks per day.
- •Subjects who have participated in a clinical research trial within 30 days prior to randomization.
- •Subjects with an allergy or sensitivity to the investigational product ingredient.
- •Subjects who are cognitively impaired and/or who are unable to give informed consent
- •Subjects who have abnormal laboratory results or any other medical or psychological condition which, in the opinion of the Principle Investigator, may adversely affect the subjects ability to complete the study or its measures or which may pose significant risk to the subject
结局指标
主要结局
Change in glucose response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo
时间窗: Baseline and week 8
Assessed by the change in the area under the curve in glucose response
次要结局
- Change in fasting glucose in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
- Change in body weight in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
- Change in HOMA-IR in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
- Change in fasting insulin in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
- Change in insulin response to 2-hour oral glucose tolerance test (OGTT) in subjects taking Glucodia™ versus Placebo(Baseline and week 8)
- Change in adiponectin levels in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
- Change in appetite in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
- Change in lipid panel levels in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
- Change in body composition in subjects taking Glucodia™ versus Placebo(Baseline, week 4 and week 8)
研究者
研究点 (2)
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