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.
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,
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)
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
Crossover
Origin Satiety Complex
Dietary supplementParticipants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container.
Placebo
Other interventionParticipants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container.
The difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety
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".
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) as assessed by the Eating Behavior VAS between IP and placebo in fasted state, after a single dose of study product (T = 0 h - T = 1.5 h). The VAS is on a scale of 1 to 10, with 1 being "not hungry at all" and 10 being "extremely hungry".
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) as assessed by the Eating Behavior VAS between IP and placebo in a postprandial state, after three doses of study product and two meals (T = 0 h - T = 5.5 ). The VAS is on a scale of 1 to 10, with 1 being "not hungry at all" and 10 being "extremely hungry".
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) as assessed by the Eating Behavior VAS between IP and placebo in a postprandial state, after three doses of study product and two meals (T = 3.5 h - T = 5.5 h). The VAS is on a scale of 1 to 10, with 1 being "not hungry at all" and 10 being "extremely hungry".
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) as assessed by the Eating Behavior VAS between IP and placebo in a postprandial state, after five doses of study product and three meals (T = 8.5 h - T = 10.5 h). The VAS is on a scale of 1 to 10, with 1 being "not hungry at all" and 10 being "extremely hungry".
Incidence of post-emergent adverse events (AE)
Incidence of post-emergent adverse events (AE)
Clinically relevant changes in blood pressure (BP) after supplementation
Clinically relevant changes in blood pressure (BP) after supplementation
Clinically relevant changes in heart rate after supplementation
Clinically relevant changes in heart rate after supplementation
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Vora Life LLC
Lead sponsor
KGK Science Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
