A randomized, double blind, parallel assignment, placebo-controlled, two arm study to evaluate the safety and efficacy of iPulse (multi fruit blend juice) in overweight adult healthy volunteers
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- 1.Primary Measurement will be the safety and tolerability of iPulse through Laboratory Parameters
研究概览
简要总结
Obesityand metabolic syndrome are considered to be major public health crises not onlyin the United States but also globally. An expert panel convened by theNational Institutes of Health has defined overweight as a body mass index (BMI)of 25 to 29.9 kg/m2 and obesity as a BMI of 30 kg/m2 or greater. According tothe World Health Organization (WHO), as of 2005 there were approximately 1.6billion overweight adults globally, of whom at least 300 million wereclinically obese. The prevalence of overweight and obese American adults hassteadily increased over the years in both genders, at all ages, in all racialand ethnic groups, at all educational levels, and for all smoking levels. Moststudies show an increase in mortality rates associated with obesity.Individuals who are obese have a 10%–50% increased risk of death from allcauses, compared with healthy-weight individuals. Most of the increased risk isdue to cardiovascular causes. Obesity is associated with about 112,000 excessdeaths per year in the U.S. population relative to healthy-weight individuals.
iPulse has numerous effects on the body. iPulse contains a rich blend of antioxidant fruits which mainly protects us from numerous diseases for wellbeing and healthy life. It prevents us from the neurodengerative problems, supports healthy memory, helps to prevent respiratory related problem, improves resistance against allergies, protection of liver, controls the homeostasis level, helps reduce GI problems, it maintains healthy vision, improves circulation in the eyes, helps to synthesis of plasma cells (WBS, RBC and platelets), supports healthy haemoglobin level and healthy immunity
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •Age/sex: men and women (1:1, equal distribution) aged 18-55 years (Preferably subgroup of age 18-35 and age 36-55, if feasible) 2)Subject with BMI 25-30 kg/m2 3)Subjects who perceive themselves to be under stress and having a score of 14-24 on the Perceived Stress Scale (PSS).
- •Healthy subjects as determined by: Medical history, Physical examination and Clinical judgment of the investigator 5)Subject willing to provide written informed consent and comes for regular follow up.
- •Subjects who agree to stop from using supplements during the study 7)Subjects willing to follow the suggested diet plan.
排除标准
- •Female subjects who are pregnant, lactating or planning to become pregnant during the study period.
- •Known history of any chronic illness taking regular pharmacological agents.
- •Significant Gastrointestinal (i.e. inflammatory bowel disease, celiac), liver or kidney disease 4)Cardiac condition that compromises normal function (e.g. mitral valve disease, heart failure) 5)History of major cardiovascular events in the last 1 year (stroke or myocardial infraction) 6)History of drug dependence or any severe co-morbid medical conditions.
- •High alcohol intake (>2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc., Nicotine/Caffeine dependence.
- •Administration of any other multivitamins/herbal product/wellness products 9)Subject has participated in a clinical study within the last 30 days prior to entering this study.
结局指标
主要结局
1.Primary Measurement will be the safety and tolerability of iPulse through Laboratory Parameters
时间窗: Baseline, 4 weeks and 8 weeks
次要结局
- 2.Secondary Measurement will be to assess the efficacy of I-Pulse through Demographics (Body weight, BMI, Waist circumference)(Day 0,Day 45 and Day 90)