A Randomized, Triple-blind, Placebo-controlled, Cross-over Clinical Trial to Determine the Safety and Efficacy of an Origin Satiety Complex on Self-reported Hunger and Satiety in Healthy Adults
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Vora Life LLC
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety
概览
简要总结
The goal of this clinical trial is to the safety and efficacy of the investigational product (IP), Origin Satiety Complex, on hunger and satiety in healthy adults. The main question it aims to answer is what is the difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety (T = 0 - T = 10.5 h), as assessed by satiety and hunger items of the Eating Behavior Visual Analog Scales (VAS), between the IP and placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males \& females 21 - 50 years of age, inclusive
- •BMI between 18.5 - 29.9 kg/m²
- •Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or,
- •Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. 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
- •Intrauterine devices
- •Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
- •Vasectomy of partner at least 6 months prior to screening
- •Abstinence and agrees to use contraception if planning on becoming sexually active during the study
排除标准
- •Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
- •Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo, or standardized meal ingredients
- •Poor venous access as assessed by the QI
- •Following a specific diet (e.g., vegetarian, paleo, ketogenic, carnivore, etc.), as assessed by the QI
- •Unstable metabolic disease or chronic diseases as assessed by the QI
- •Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
- •Current or history of eating disorders or restricted eating as assessed by the QI
- •Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)
- •Type I or Type II diabetes
- •Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
研究组 & 干预措施
Origin Satiety Complex
Origin Satiety Complex consists of a mix of L-glutamine, fiber blend, spinach whole herb extract, sweet potato powder, blueberry fruit extract, green coffee bean extract, cinnamon bark extract, and a probiotic blend.
干预措施: Origin Satiety Complex (Dietary Supplement)
Placebo
Placebo consists of a commercially available juice powder, Tang.
干预措施: Placebo (Other)
结局指标
主要结局
The difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety
时间窗: Time (T) 0 to 10.5 hours
The difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety (T = 0 - T = 10.5 h), as assessed by satiety and hunger items of the Eating Behavior Visual Analog Scales (VAS), between the IP and placebo. The VAS is on a scale of 1 to 10, with 1 being "not hungry at all" and 10 being "extremely hungry".
次要结局
- The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.(0 to 1.5 hours)
- The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.(0 to 5.5 hours)
- The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.(3.5 to 5.5 hours)
- The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.(8.5 to 10.5 hours)
- The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.(1.5 to 3.75 hours)
- The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.(4.5 to 8.5 hours)
- The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.(9.5 to 10.5 hours)
- The difference in self-reported eating behavior (hunger, fullness, nausea, thirst, amount of food they could eat) 90 minutes after each meal(1.75, 3.75, and 8.75 hours after T0 h)
- The difference in postprandial glucose between IP and placebo(Baseline and 3, 5, 5.5, and 10 hours)
- The difference in niAUC(0-10h) for serum glucose between IP and placebo(0 to 10 hours)
- The difference in niAUC(0-10h) for serum insulin between IP and placebo(0 to 10 hours)