High BMINCT07390266
A Clinical Trial to Determine the Safety and Efficacy of an Origin Satiety Complex on Self-reported Hunger and Satiety in Healthy Adults
A study testing Origin Satiety Complex in people with High BMI and Hunger, run by Vora Life LLC at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Origin Satiety Complex
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2026to Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
- 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)
Who cannot join
- 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
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- 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
- 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
- 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
- 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
- Gastric bypass surgery or other surgeries to induce weight loss
- 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
- Individuals with an autoimmune disease or are immune compromised as assessed by the QI
- Self-reported confirmation of a HIV-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
- Self-reported confirmation of blood/bleeding disorders as assessed by the QI
- Self-reported confirmation of hypercalcemia and/or hypercalciuria diagnosis, as assessed by the QI
- Use of medical cannabinoid products
- Chronic use of cannabinoid products (>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period
- 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
- Alcohol intake average of >2 standard drinks per day as assessed by the QI
- Alcohol or drug abuse within the last 12 months
- 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)
- Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI
- Individuals who are unable to give informed consent
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
KGK Science Inc.
London, Ontario, N6B3L1
Marc Moulin, PhD, 2267819094, mmoulin@kgkscience.com
David Crowley, MD
About this study
Official title: 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
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.
- Conditions
- High BMI, Hunger, Satiety, Healthy Adults
- Being tested
- Origin Satiety Complex, Placebo
- Keywords
- Vora Life, Origin Satiety Complex
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Origin Satiety ComplexDietary supplement
Participants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container.
PlaceboOther
Participants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Origin Satiety Complex |
| Placebo | Placebo comparator | Placebo consists of a commercially available juice powder, Tang. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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".
Measured: Time (T) 0 to 10.5 hours
Secondary outcomes (12)
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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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".
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0 to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High BMIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vora Life LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07390266
- Sponsor's protocol ID
- 25VRLCR01
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07390266
- Acronym / sponsor ID
- 25VRLCR01
- Conditions
- High BMI, Hunger, Satiety, Healthy Adults
- Keywords
- Vora Life, Origin Satiety Complex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vora Life LLCIndustry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc.
- Study start
- Mar 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Origin Satiety Complex | Experimental | Dietary Supplement: Origin Satiety ComplexOrigin 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 | Other: PlaceboPlacebo consists of a commercially available juice powder, Tang. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Origin Satiety ComplexParticipants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container. | Dietary supplement | Origin Satiety Complex |
| PlaceboParticipants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container. | Other | Placebo |
Primary outcome
The difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety
Time frame: 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".
12 secondary outcomes
The difference in niAUC for self-reported eating behaviors (hunger, fullness, nausea, thirst, amount of food they could eat) between IP and placebo.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 1.75, 3.75, and 8.75 hours after T0 h
The difference in postprandial glucose between IP and placebo
Time frame: Baseline and 3, 5, 5.5, and 10 hours
The difference in postprandial glucose between IP and placebo
Time frame: Baseline and 3, 5, 5.5, and 10 hours
The difference in niAUC(0-10h) for serum glucose between IP and placebo
Time frame: 0 to 10 hours
The difference in niAUC(0-10h) for serum insulin between IP and placebo
Time frame: 0 to 10 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Origin Satiety Complex in people with High BMI and Hunger, run by Vora Life LLC at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Moulin, PhD (2267819094, mmoulin@kgkscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the net incremental area under the curve (niAUC) for self-reported postprandial hunger and satiety (time frame: Time (T) 0 to 10.5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2026.