A Placebo-Controlled Study Evaluating the Effects of Arrabina on Satiety in Healthy Adults

A Randomized, Double-Blind, Parallel, 3-Arm, Placebo-Controlled Study Evaluating the Effects of Arrabina on Satiety in Healthy Adults

This study is being conducted to assess the effects of a prebiotic product, Arrabina, on appetite in healthy adults. The goal is to see if this product can help with appetite regulation, support gut health, and support weight management.

Study Overview

• Status: Completed
• Conditions: Appetite Regulation; Satiety; Weight Control
• Intervention / Treatment: Other: Placebo; Dietary supplement: Arrabina Prebiotic 5.0 g; Dietary supplement: Arrabina Prebiotic 3.5 g

Detailed Description

This is a randomized, double-blind, parallel, 3-arm, placebo-controlled study to assess the effects of Arrabina Prebiotic on satiety in healthy adults. The primary goal of this study is to assess how two different doses of Arrabina affect self-reported appetite. Secondary goals include evaluating weight control, eating behaviors, mood, sleep quality, and memory. The product is expected to support beneficial gut bacteria, help maintain lipid levels, and promote digestive comfort and appetite regulation.

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Hileah, Florida, United States, 33012
      • Indago Research Health Center,Inc.
    • Tampa, Florida, United States, 33614
      • Vantage Clinical Trials, LLC
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials - Alcanza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Generally healthy male and female participants who are between 18 - 65 years of age (inclusive).
2. Have a body mass index (BMI) range of 25.0 - 29.9 kg/m2 (inclusive).

3. Female participants must meet one of the following criteria:

   • Have a regular menstrual cycle, defined as a consistent cycle length of 24-32 days for participants in the main group and 26-32 days for participants in the subgroup and demonstrated during the screening period
   • No longer menstruate due to medication (e.g., those taking birth control shots like Depo-Provera®)
   • No longer menstruate due to being postmenopausal, surgical removal of ovaries, or medically documented ovarian failure
4. Have the habit of consuming food in the morning daily, and agree to fully consume a standardized high-carbohydrate breakfast within 15 minutes at Visit 2, Visit 3 and Visit 4.
5. Have veins suitable for repeated blood sampling in subgroup only.
6. Have maintained dietary habits and lifestyle within 3 months prior to screening and willing to maintain their habitual diets and lifestyle throughout the study.
7. Agree to follow the restrictions on concomitant treatments as listed
8. Willing and able to adhere to the requirements and restrictions of this study, willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion Criteria:

1. Individuals who are lactating, pregnant or planning to become pregnant during the study.
2. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
3. Have Type I diabetes or Type II diabetes, high blood pressure (≥140 systolic or ≥90 diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as being unmedicated, have an unstable use of medication within 3 months prior to screening, or have a stable use of medication for 3 months but still have uncontrolled conditions).
4. Current high fiber intake (estimated to be ≥ 30 g per day as estimated by a questionnaire at screening).
5. Currently participating in a weight management program or on a specific diet (e.g., Atkins, keto, intermittent fasting, etc.), or participated in a weight management program with its completion occurred within 3 months prior to baseline.
6. Experienced a change in body weight of ±4.5 kg (10 lbs.) over the 3 months prior to baseline.
7. Have eating disorder(s) (e.g., bulimia, binge eating disorder, etc.).
8. Have medical condition(s) known to manifest gastrointestinal symptoms (e.g., irritable bowel syndrome, endometriosis, etc.).
9. Have medical condition(s) known to interfere with absorption, distribution, metabolism, or excretion of the study product (e.g., Crohn's disease, short bowel, acute or chronic pancreatitis, or pancreatic insufficiency).
10. Have a history of heart/cardiovascular disease, renal disease (dialysis or renal failure), hepatic impairment/disease, immune disorders and/or immunocompromised (i.e., HIV/AIDS).
11. Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer) with recovery occurred within 5 years before the screening visit.
12. Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
13. Reports a clinically significant illness during the 28 days before the first dose of study product.
14. Major surgery in 3 months prior to screening or planned major surgery during the study.
15. Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that to the opinion of the investigator may be of a concern for the study.
16. Currently, or plan to, live in the same household with another participant in the current study during the study period.
17. Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 28 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study.
18. Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Not Active Powder per sachet	Other: Placebo; Placebo Powder
Experimental: Arrabina Prebiotic 5.0 g; Active Arrabina Prebiotic 5.0 g fiber per sachet	Dietary supplement: Arrabina Prebiotic 5.0 g; Active Powder
Experimental: Arrabina Prebiotic 3.5 g; Active Arrabina Prebiotic 3.5 g fiber per sachet	Dietary supplement: Arrabina Prebiotic 3.5 g; Active Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 4 in incremental area under the curve (iAUC) of the following self-reported appetite sensations, with each sensation measured using a 100 mm visual analogue scale (VAS) over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Fullness	Week 4
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 4 in incremental area under the curve (iAUC) of the following self-reported appetite sensations, with each sensation measured using a 100 mm visual analogue scale (VAS) over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Prospective food consumption	Week 4
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 4 in incremental area under the curve (iAUC) of the following self-reported appetite sensations, with each sensation measured using a 100 mm visual analogue scale (VAS) over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Hunger.	Week 4
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 4 in incremental area under the curve (iAUC) of the following self-reported appetite sensations, with each sensation measured using a 100 mm visual analogue scale (VAS) over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Satiation	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 12 in iAUC of the following self-reported appetite sensations, with each sensation measured using a 100 mm VAS over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Hunger	Week 12
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 12 in iAUC of the following self-reported appetite sensations, with each sensation measured using a 100 mm VAS over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Fullness	Week 12
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 12 in iAUC of the following self-reported appetite sensations, with each sensation measured using a 100 mm VAS over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Prospective food consumption	Week 12
To evaluate the effect of TP at two dose levels on body weight, compared to placebo	Percent change from baseline to Week 12 in body weight	Week 12
To evaluate the effect of TP at two dose levels on eating behaviours, compared to placebo	Change from baseline to Week 4 in eating behaviors as assessed by the following questionnaires 2 hours after the consumption of a standardized high-carbohydrate breakfast - Three-Factor Eating Questionnaire (TFEQ)	Week 4
To evaluate the effect of TP at two dose levels on eating behaviours, compared to placebo	Change from baseline to Week 12 in eating behaviors' as assessed by the following questionnaires 2 hours after the consumption of a standardized high-carbohydrate breakfast - Three-Factor Eating Questionnaire (TFEQ)	Week 12
To evaluate the effect of TP at two dose levels on eating behaviours, compared to placebo	Change from baseline to Week 4 in eating behaviors' as assessed by the following questionnaires 2 hours after the consumption of a standardized high-carbohydrate breakfast - Food Craving Questionnaire-Trait (FCQ-T)	Week 4
To evaluate the effect of TP at two dose levels on eating behaviors, compared to placebo	Change from baseline to Week 12 in eating behaviors' as assessed by the following questionnaires 2 hours after the consumption of a standardized high-carbohydrate breakfast - Food Craving Questionnaire-Trait (FCQ-T)	Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 4 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: Total Cholesterol	Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 12 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: Total Cholesterol	Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 4 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: High-density lipoprotein (HDL) cholesterol	Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 12 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: High-density lipoprotein (HDL) cholesterol	Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 4 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: Low-density lipoprotein (LDL) cholesterol	Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 12 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: Low-density lipoprotein (LDL) cholesterol	Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 4 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: Triglycerides	Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo	Change from baseline to Week 12 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: Triglycerides	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Bifidobacteriaceae (B.longum) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Bifidobacteriaceae (B.longum) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Bifidobacteriaceae (B. bifidum) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Bifidobacteriaceae (B. bifidum) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Prevotellaceae (P. copri) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Prevotellaceae (P. copri) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Bacteriodes (C. cellulosilyticus) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Bacteriodes (C. cellulosilyticus) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Bacteriodes (B.thetaiotaomicron) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Bacteriodes (B.thetaiotaomicron) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Bacteriodes (B. intestinalis) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Bacteriodes (B. intestinalis) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Lactobacillaceae (Lactobacillus) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Lactobacillaceae (Lactobacillus) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Ruminococceae (F. prausnitzzi) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Ruminococceae (F. prausnitzzi) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Lachnospiraceae (R. hominis) as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Lachnospiraceae (R. hominis) as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Akkermansia spp as assessed by 16s RNA sequencing	Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo	Change from baseline to Week 12 stool sample in the abundance of the following beneficial microbes: Akkermansia spp as assessed by 16s RNA sequencing	Week 12
To evaluate the effect of TP at two dose levels on gastrointestinal health, compared to placebo	Changes from baseline to Week 4 in gastrointestinal symptoms rating scales (GSRS)	Week 4
To evaluate the effect of TP at two dose levels on gastrointestinal health, compared to placebo	Changes from baseline to Week 12 in gastrointestinal symptoms rating scales (GSRS)	Week 12
To evaluate the effect of TP at two dose levels on mood, compared to placebo	Changes from baseline to Week 4 in mood state as assessed by the Brunel Mood Scale Questionnaire (BRUMS-24) total mood disturbance score and sub-scales	Week 4
To evaluate the effect of TP at two dose levels on mood, compared to placebo	Changes from baseline to Week 12 in mood state as assessed by the Brunel Mood Scale Questionnaire (BRUMS-24) total mood disturbance score and sub-scales	Week 12
To evaluate the effect of TP at two dose levels on sleep quality, compared to placebo	Changes from baseline to Week 4 in sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI)	Week 4
To evaluate the effect of TP at two dose levels on sleep quality, compared to placebo	Changes from baseline to Week 12 in sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI)	Week 12
To evaluate the effect of TP at two dose levels on memory, compared to placebo	Changes from baseline to Week 4 in memory as assessed by Multifactorial Memory Questionnaire (MMQ)	Week 4
To evaluate the effect of TP at two dose levels on memory, compared to placebo	Changes from baseline to Week 12 in memory as assessed by Multifactorial Memory Questionnaire (MMQ)	Week 12
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial glucose and insulin response, compared to placebo	Changes from baseline to Week 4 in the postprandial profile of glucose and insulin over 4 hours after a standardized high-carbohydrate breakfast with each dose level of TP or placebo	Week 4
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	Change from baseline to Week 12 in iAUC of the following self-reported appetite sensations, with each sensation measured using a 100 mm VAS over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Satiation	Week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo	Changes from baseline to Week 4 in serum lipopolysaccharide binding protein (LBP), with each dose level of TP or placebo	Week 4
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo	Changes from baseline to Week 12 in serum lipopolysaccharide binding protein (LBP), with each dose level of TP or placebo	Week 12
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo	Changes from baseline to Week 4 in serum zonulin, with each dose level of TP or placebo	Week 4
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo	Changes from baseline to Week 12 in serum zonulin, with each dose level of TP or placebo	Week 12
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo	Changes from baseline to Week 4 and in fecal calprotectin, with each dose level of TP or placebo	Week 4
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo	Changes from baseline to Week 12 and in fecal calprotectin, with each dose level of TP or placebo	Week 12
To assess the safety and tolerability of the TP in healthy participants	Vitals: Heart rate in beats per minute (bpm)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Vitals: Blood Pressure in mmhg	Week 12
To assess the safety and tolerability of the TP in healthy participants	Anthropometrics - Weight in kilograms (Kg)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Anthropometrics: Body Mass Index (Weight in kilograms (Kg) divided by the square of height in meters (m2)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Hemoglobin (g/dl)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Hematocrit (%)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Red Blood Cells (RBC) in million cells/mcL	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Red Blood Cell Distribution Width (RDW) in fL	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Mean Corpuscular Volume (MCV)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Mean Corpuscular Hemoglobin (MCH)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Mean Corpuscular Hemoglobin Concentration(MCHC)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: White Blood Cells (WBC) and differential (abs)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Platelet count	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Mean Platelet Volume (MPV)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Blood urea nitrogen (BUN)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Creatinine	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Bilirubin total	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Alkaline phosphatase	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: AST	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: ALT	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Albumin	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Total protein	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Sodium	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Potassium	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Estimated glomerular filtration rate (eGFR)	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Globulin	Week 12
To assess the safety and tolerability of the TP in healthy participants	Laboratory blood tests. Fasting blood samples will be collected to assess for changes in: Chloride	Week 12
To assess the safety and tolerability of the TP in healthy participants	Reports of adverse events will be collected and compared between the TP and placebo group	Week 12
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial short-chain fatty acid (SCFA) blood profiles	Change from baseline to Week 4 in postprandial profile of the following SCFA over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Acetic Acid will be quantified using GC-MS analysis	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial short-chain fatty acid (SCFA) blood profiles	Change from baseline to Week 4 in postprandial profile of the following SCFA over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Propionic acid will be quantified using GC-MS analysis	Week 4
Subgroup only:To evaluate the effect of TP at two dose levels on postprandial short-chain fatty acid (SCFA) blood profiles	Change from baseline to Week 4 in postprandial profile of the following SCFA over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Butyric acid will be quantified using GC-MS analysis	Week 4
Subgroup only:To evaluate the effect of TP at two dose levels on postprandial short-chain fatty acid (SCFA) blood profiles	Change from baseline to Week 4 in postprandial profile of the following SCFA over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Valeric acid will be quantified using GC-MS analysis	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial short-chain fatty acid (SCFA) blood profiles	Change from baseline to Week 4 in postprandial profile of the following SCFA over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Isovaleric acid will be quantified using GC-MS analysis	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial short-chain fatty acid (SCFA) blood profiles	Change from baseline to Week 4 in postprandial profile of the following SCFA over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Caproic acid will be quantified using GC-MS analysis	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial short-chain fatty acid (SCFA) blood profiles	Change from baseline to Week 4 in postprandial profile of the following SCFA over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Heptanoic acid will be quantified using GC-MS analysis	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial appetite regulating hormone response, compared to placebo	Change from baseline and Week 4 in postprandial profile of the following hormones over the following specified hours after the consumption of a standardized high-carbohydrate breakfast: Over 4 hours: Total Glucagon-like peptide-1 (GLP-1)	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial appetite regulating hormone response, compared to placebo	Change from baseline and Week 4 in postprandial profile of the following hormones over the following specified hours after the consumption of a standardized high-carbohydrate breakfast: Over 4 hours: Peptide YY (PYY)	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial appetite regulating hormone response, compared to placebo	Change from baseline and Week 4 in postprandial profile of the following hormones over the following specified hours after the consumption of a standardized high-carbohydrate breakfast: Over 2 hours: Cholecystokinin (CCK)	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on postprandial inflammatory response, compared to placebo in a subgroup of participants	Changes from baseline to Week 4 in serum IL-6 response over 4 hours after the consumption of a standardized high-carbohydrate breakfast	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: p-Hydroxyphenyllactic acid	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: caffeicacid, methylcaffeate	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: (E)-Osmundacetone, homovanillic acid, 3,4-Dimethoxyphenylacetic	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: acid/Dihydroferulic acid, 3-hydroxyphenylacetic acid	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Acetylagmatine	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: N-acetylputrescine, N-acetylcadaverine	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: Stachydrine	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: 2-hydroxyvaleric acid	Week 4
Subgroup only: To evaluate the effect of TP at two dose levels on gut metabolomics in blood, compared to placebo in subgroup of participants	Change from baseline to Week 4 in the following gut microbial metabolites over 4 hours after the consumption of a standardized high-carbohydrate breakfast: 5-aminolevulinic acid 2-hydroxyisocaproic acid	Week 4

Collaborators and Investigators

• Sponsor: Comet Bio Inc.
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
• Investigators: Study Director: Andrew Richard, Comet Biorefining Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: March 13, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 19, 2025

Study Record Updates

• Last Update Posted (Actual): February 19, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Satiety; Appetite; Weight Management
• Other Study ID Numbers: C02-24-01-T0076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No