NCT02188251已完成2 期
A Randomized, Double-blind, Placebo Controlled, Parallel Study Investigating the Effects of Activamp on Body Weight, Fat Loss, and Metabolic Markers in Healthy Overweight Participants
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in body weight
研究概览
简要总结
The purpose of this study is to determine the effects of Activamp, a product containing gynostemma pentaphyllum extract, on body weight, fat loss and metabolic markers in healthy overweight adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female 21-55 years of age
- •BMI of 25.0 kg/m2 to 29.9 kg/m2 (± 1.0kg/m2)
- •Must have negative urine pregnancy test at screening
- •Female subject of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result.
- •Subject agrees to maintain their normal level of physical activity throughout the study
- •Weight has been stable for the last 3 months
- •Subject agrees to comply with study procedures
- •Healthy as determined by laboratory results, medical history and physical exam
- •Subject agrees not to participate in structured activity including resistance training and aerobic exercise more than 3 times per week
- •Has given voluntary, written, informed consent to participate in the study
排除标准
- •Women who are pregnant, breastfeeding, or planning to become pregnant during the course of the trial
- •Subject who have experienced a greater than 10% variation in body weight in the past 3 months
- •History of, or current diagnosis of any major diseases of the cardiovascular, hepatic, renal, gastrointestinal, pulmonary or endocrine systems
- •History of surgery for weight loss (including gastric bypass or lapband)
- •History of conditions that could interfere with the test product or impede its absorption such as gastrointestinal disease (Crohn's disease) or experienced surgery (caecum or enterocele surgery)
- •Subjects diagnosed with Type II Diabetes
- •Subjects with active cancer (excluding basal cell carcinoma)
- •Subjects with active eating disorders
- •Subjects who have undergone anti-psychotic drug therapy within the past 2 months
- •Use of prescription or over the counter medications known to affect weight within 3 weeks of randomization or during the study
- •Use of any supplements, programs, or meal replacement products, other than those provided, intended to alter body weight within two weeks of screening or during the course of the study
- •Use of illicit drugs or history of drug or alcohol abuse within the past 6 months
- •Currently having more than 2 standard alcoholic drinks per day
- •Participation in a clinical research trial within 30 days prior to randomization
- •Allergy or sensitivity to test article ingredients
- •Individuals who are cognitively impaired and/or who are unable to give informed consent
- •Abnormal lab test results or any other medical or psychological condition which in the Investigator's opinion may adversely affect the subject's ability to complete the study or its measures or which may pose significant risk to the subject
研究组 & 干预措施
Activamp
Experimental
Capsules containing 225mg of Activamp (Gynostemma pentaphyllum extract), 1 capsule taken twice daily for 12 weeks
干预措施: Activamp (Dietary Supplement)
Placebo
Placebo Comparator
1 capsule taken twice daily for 12 weeks
干预措施: Placebo (Other)
结局指标
主要结局
Change in body weight
时间窗: Baseline to week 12
次要结局
- Change in calculated lean body mass(Baseline to week 12)
- Change in calculated BMI(baseline to week 12)
- Change in calculated percent body fat(Baseline to week 12)
- Change in calculated body fat mass(Baseline to week 12)
- Change in total body fat percentage(Baseline to week 12)
- Change in total fat mass(Baseline to week 12)
- Change in total lean mass(Baseline to week 12)
- Change in percent android fat(Baseline to week 12)
- Change in percent gynoid fat(Baseline to week 12)
- Change in percent trunk and legs fat(Baseline to week 12)
- Change in percent abdominal fat(Baseline to week 12)
- Change in anthropometric measurements(Baseline to 12 weeks)
- Change in blood AMPK activity(Baseline to week 12)
- Change in blood metabolic parameters(Baseline to 12 weeks)
- Change in blood safety parameters(Baseline to week 12)
- Changes in safety vital signs(Baseline to week 12)
- Incidence of adverse events(Baseline to week 12)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced StrainChronic Stress-Induced StrainNCT03277833Chonbuk National University Hospital72
已完成
1 期
A Double-blind Randomized Placebo-controlled Study of Safety and Immunogenicity of GamEvac-LyoHealthy VolunteersNCT03333538Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation220
Unknown
2 期
Study of Gemcitabine/Carboplatin First-line Chemotherapy +/- Apatorsen in Advanced Squamous Cell Lung CancersSquamous Cell Lung CancerNCT02423590Queen Mary University of London140
已完成
4 期
Efficacy and Safety of Garamycin® Sponge in Diabetic Patients With a Moderate or Severe Foot Ulcer InfectionDiabetic Foot UlcerNCT01951768University Hospital, Geneva88
Unknown
3 期
Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High ExpressionNon-small Cell Lung CancerNCT01977209Third Military Medical University204