A Clinical Trial to Determine the Safety and Efficacy of an Origin Satiety Complex on Self-reported Hunger and Satiety in Healthy Adults

NCT07390266 | Not Yet Recruiting

• 1 other identifier: 25VRLCR01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

Vora Life; Origin Satiety Complex

Outcome Measures

Primary Outcomes (1)

• 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

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.

  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

Other Outcomes (3)

• Incidence of post-emergent adverse events (AE)

  0 to 10.5 hours

• Clinically relevant changes in blood pressure (BP) after supplementation

  0 to 10.5 hours

• Clinically relevant changes in heart rate after supplementation

  0 to 10.5 hours

Study Arms (2)

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.

Dietary Supplement: Origin Satiety Complex

Placebo

PLACEBO COMPARATOR

Placebo consists of a commercially available juice powder, Tang.

Other: Placebo

Interventions

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.

Origin Satiety Complex

Placebo OTHER

Participants will be instructed to consume five doses of study product premixed in 10 ounces of water in an opaque container.

Placebo

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Vora Life LLC: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N6B3L1, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marc Moulin, PhD

CONTACT

2267819094; mmoulin@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-01

Locations

CA (1)