NCT01725958已完成4 期
A Phase IV, Open-label, Parallel Group, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management Over a 90-day Period
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pharmanex
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- -Evaluate the changes in body composition as determined by percent body fat using the Bod Pod
研究概览
简要总结
Title: A Phase IV, Open-label, Single-Center Study on the Effects of a Nutritional Supplement Combination on Body Weight Management over a 90-day period
详细描述
Safety assessment:
Safety will be assessed by changes in blood chemistries/hematology, and adverse events, of nutritional supplement emergent AEs (TEAEs), classified by severity grade, relatedness to the nutritional supplement.
Efficacy Assessment:
The objectives of this study are to evaluate the efficacy (changes in body composition and measurements as well as influence on appetite and quality of life changes) of the nutritional supplement administered repeatedly throughout the study.
Study Subject Population:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Females and Males aged 25-65 years
- •Signed informed consent
- •BMI between 25 and 40 kg/m2
- •A resting normotensive blood pressure is defined as a systolic blood pressure between 90-145 mmHg and a diastolic blood pressure of 50 90 mmHg
- •Use of effective method of contraception by females of childbearing [potential and agreement to continue to practice an acceptable method of contraception for the duration of their participation in the study]. Acceptable methods of contraception include oral, injectable, or implantable contraceptives; intrauterine devices, diaphragm plus spermicide; abstinence (must agree to use double-barrier method if they become sexually active), transdermal patch, or any double barrier method including a vasectomized sexual partner. Women who have had a hysterectomy or tubal ligation at least 6 months prior to Visit 1 or who have been post-menopausal
- •Ability to speak and understand English
- •Willing to fast the morning of visit where blood samples are taken
排除标准
- •Self-reported chronic condition that may affect subject safety (e.g., diabetes, cardiovascular disease) or significantly impact product effectiveness (e.g., chronic fatigue)
- •Pregnancy/suspected pregnancy, breastfeeding or planning to become pregnant during the course of the study.
- •Use of Antihypertensive medication for less than 4 months or unregulated clinically blood pressure.
- •Having undergone gastroplasty or bariatric surgery in the past 10 years.
- •Taking medication (e.g., thyroid medication), must be stable for at least four months.
- •Allergies to any ingredients contained in the Nutritional Supplement.
- •Medical treatment for insomnia or depression within 30-days prior to the screening visit.
- •Tobacco (e.g. cigarettes, chewing tobacco, pipe, nicotine patches) use within 30-days prior to the screening visit.
- •Planned surgical procedure during the course of the study.
- •Currently participating in another study or have done so within 30 days prior to the screening visit or is likely to enroll in another clinical or nutritional study.
- •Currently taking any medication or supplement for the use of weight loss must be discontinued prior to Visit 1 Baseline Day
- •Currently participating in a weight loss program or participated in a weight loss program in the past 6 months.
结局指标
主要结局
-Evaluate the changes in body composition as determined by percent body fat using the Bod Pod
时间窗: 90 Days
次要结局
- Evaluate the changes in body weight(90 days)
研究者
研究点 (2)
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