Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
Study NCT ID:
NCT07390266
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-05
First Post:
2026-01-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Determine the Safety and Efficacy of an Origin Satiety Complex on Self-reported Hunger and Satiety in Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-28', 'studyFirstSubmitQcDate': '2026-01-28', 'lastUpdatePostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incidence of post-emergent adverse events (AE)', 'timeFrame': '0 to 10.5 hours', 'description': 'Incidence of post-emergent adverse events (AE)'}, {'measure': 'Clinically relevant changes in blood pressure (BP) after supplementation', 'timeFrame': '0 to 10.5 hours', 'description': 'Clinically relevant changes in blood pressure (BP) after supplementation'}, {'measure': 'Clinically relevant changes in heart rate after supplementation', 'timeFrame': '0 to 10.5 hours', 'description': 'Clinically relevant changes in heart rate after supplementation'}], 'primaryOutcomes': [{'measure': 'The difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety', 'timeFrame': 'Time (T) 0 to 10.5 hours', 'description': '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".'}], 'secondaryOutcomes': [{'measure': 'The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.', 'timeFrame': '0 to 1.5 hours', 'description': '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': 'The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.', 'timeFrame': '0 to 5.5 hours', 'description': '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".'}, {'measure': 'The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.', 'timeFrame': '3.5 to 5.5 hours', 'description': '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".'}, {'measure': 'The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.', 'timeFrame': '8.5 to 10.5 hours', 'description': '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".'}, {'measure': 'The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.', 'timeFrame': '1.5 to 3.75 hours', 'description': '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".'}, {'measure': 'The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.', 'timeFrame': '4.5 to 8.5 hours', 'description': '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".'}, {'measure': 'The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.', 'timeFrame': '9.5 to 10.5 hours', 'description': '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".'}, {'measure': 'The difference in self-reported eating behavior (hunger, fullness, nausea, thirst, amount of food they could eat) 90 minutes after each meal', 'timeFrame': '1.75, 3.75, and 8.75 hours after T0 h', 'description': '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.'}, {'measure': 'The difference in postprandial glucose between IP and placebo', 'timeFrame': 'Baseline and 3, 5, 5.5, and 10 hours', 'description': 'The difference in postprandial glucose at T = 3, 5, 5.5, and 10 h between IP and placebo'}, {'measure': 'The difference in postprandial glucose between IP and placebo', 'timeFrame': 'Baseline and 3, 5, 5.5, and 10 hours', 'description': 'The difference in postprandial insulin at T = 3, 5, 5.5, and 10 h between IP and placebo'}, {'measure': 'The difference in niAUC(0-10h) for serum glucose between IP and placebo', 'timeFrame': '0 to 10 hours', 'description': 'The difference in niAUC(0-10h) for serum glucose between IP and placebo'}, {'measure': 'The difference in niAUC(0-10h) for serum insulin between IP and placebo', 'timeFrame': '0 to 10 hours', 'description': 'The difference in niAUC(0-10h) for serum insulin between IP and placebo'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vora Life', 'Origin Satiety Complex'], 'conditions': ['High BMI', 'Hunger', 'Satiety', 'Healthy Adults']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males \\& females 21 - 50 years of age, inclusive\n2. BMI between 18.5 - 29.9 kg/m²\n3. 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,\n\n 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:\n * 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)\n * Double-barrier method\n * Intrauterine devices\n * Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)\n * Vasectomy of partner at least 6 months prior to screening\n * Abstinence and agrees to use contraception if planning on becoming sexually active during the study\n4. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits\n5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study\n6. Agrees to consume the standardized dinner the night prior to study visits and comply with fasting requirements\n7. 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\n8. Provided voluntary, written, informed consent to participate in the study\n9. Healthy as determined by medical history as assessed by the Qualified Investigator (QI)\n\nExclusion Criteria:\n\n1. Individuals who are pregnant, breast feeding, or planning to become pregnant during the study\n2. Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product, placebo, or standardized meal ingredients\n3. Poor venous access as assessed by the QI\n4. Following a specific diet (e.g., vegetarian, paleo, ketogenic, carnivore, etc.), as assessed by the QI\n5. Unstable metabolic disease or chronic diseases as assessed by the QI\n6. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI\n7. Current or history of eating disorders or restricted eating as assessed by the QI\n8. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)\n9. Type I or Type II diabetes\n10. 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\n11. History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months\n12. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI\n13. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI\n14. Gastric bypass surgery or other surgeries to induce weight loss\n15. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable\n16. Individuals with an autoimmune disease or are immune compromised as assessed by the QI\n17. Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI\n18. Self-reported confirmation of blood/bleeding disorders as assessed by the QI\n19. Self-reported confirmation of hypercalcemia and/or hypercalciuria diagnosis, as assessed by the QI\n20. Use of medical cannabinoid products\n21. Chronic use of cannabinoid products (\\>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period\n22. Regular use of tobacco or nicotine products in the past six months, as assessed by the QI. Occasional users will be required to washout and abstain for the duration of the study period\n23. Alcohol intake average of \\>2 standard drinks per day as assessed by the QI\n24. Alcohol or drug abuse within the last 12 months\n25. Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the safety and/or efficacy of the investigational product (Sections 7.3.1 and 7.3.2)\n26. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI\n27. Individuals who are unable to give informed consent\n28. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant"}, 'identificationModule': {'nctId': 'NCT07390266', 'briefTitle': 'A Clinical Trial to Determine the Safety and Efficacy of an Origin Satiety Complex on Self-reported Hunger and Satiety in Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vora Life LLC'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '25VRLCR01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Origin Satiety Complex', 'description': '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.', 'interventionNames': ['Dietary Supplement: Origin Satiety Complex']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo consists of a commercially available juice powder, Tang.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Origin Satiety Complex', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container.', 'armGroupLabels': ['Origin Satiety Complex']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Participants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6B3L1', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Marc Moulin, PhD', 'role': 'CONTACT', 'email': 'mmoulin@kgkscience.com', 'phone': '2267819094'}, {'name': 'David Crowley, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'KGK Science Inc.', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'centralContacts': [{'name': 'Marc Moulin, PhD', 'role': 'CONTACT', 'email': 'mmoulin@kgkscience.com', 'phone': '2267819094'}], 'overallOfficials': [{'name': 'David Crowley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KGK Science Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vora Life LLC', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KGK Science Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}