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| Name | Class |
|---|---|
| KGK Science Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Origin Satiety Complex | Experimental | 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. |
|
| Placebo | Placebo Comparator | Placebo consists of a commercially available juice powder, Tang. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Origin Satiety Complex | Dietary Supplement | Participants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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". | Time (T) 0 to 10.5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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". |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of post-emergent adverse events (AE) | Incidence of post-emergent adverse events (AE) | 0 to 10.5 hours |
| Clinically relevant changes in blood pressure (BP) after supplementation | Clinically relevant changes in blood pressure (BP) after supplementation |
Inclusion Criteria:
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:
Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study
Agrees to consume the standardized dinner the night prior to study visits and comply with fasting requirements
Agrees to avoid alcohol consumption in the 24 hours prior to clinic visits and caffeine consumption and physical exercise on the morning of each study visit
Provided voluntary, written, informed consent to participate in the study
Healthy as determined by medical history as assessed by the Qualified Investigator (QI)
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc Moulin, PhD | Contact | 2267819094 | mmoulin@kgkscience.com |
| Name | Affiliation | Role |
|---|---|---|
| David Crowley, MD | KGK Science Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KGK Science Inc. | London | Ontario | N6B3L1 | Canada |
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| Placebo | Other | Participants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container. |
|
| 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. | 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". | 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. | 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". | 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. | 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". | 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. | 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 breakfast and two doses of study product (T = 1.5 h - T = 3.75 h). The VAS is on a scale of 1 to 10, with 1 being "not hungry at all" and 10 being "extremely hungry". | 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. | 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 lunch and four doses of study product (T = 4.5 h - T = 8.5 h). The VAS is on a scale of 1 to 10, with 1 being "not hungry at all" and 10 being "extremely hungry". | 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. | 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 dinner and five doses of study product (T = 9.5 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". | 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 | The difference in self-reported eating behavior (hunger, fullness, nausea, thirst, amount of food they could eat) 90 minutes after each meal as assessed by the Eating Behavior VAS between IP and placebo. | 1.75, 3.75, and 8.75 hours after T0 h |
| The difference in postprandial glucose between IP and placebo | The difference in postprandial glucose at T = 3, 5, 5.5, and 10 h between IP and placebo | Baseline and 3, 5, 5.5, and 10 hours |
| The difference in postprandial glucose between IP and placebo | The difference in postprandial insulin at T = 3, 5, 5.5, and 10 h 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 | 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 | The difference in niAUC(0-10h) for serum insulin between IP and placebo | 0 to 10 hours |
| 0 to 10.5 hours |
| Clinically relevant changes in heart rate after supplementation | Clinically relevant changes in heart rate after supplementation | 0 to 10.5 hours |