SatietyNCT06884449
A Placebo-Controlled Study Evaluating the Effects of Arrabina on Satiety in Healthy Adults
A study testing Arrabina Prebiotic 5.0 g and Arrabina Prebiotic 3.5 g in people with Satiety and Appetite Regulation, run by Comet Bio Inc. at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Satiety, Appetite Regulation, Weight Control
- What is being tested?
- Arrabina Prebiotic 5.0 g and Arrabina Prebiotic 3.5 g
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2025to 20 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Generally healthy male and female participants who are between 18 - 65 years of age (inclusive).
- Have a body mass index (BMI) range of 25.0 - 29.9 kg/m2 (inclusive).
- 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
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- 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.
- Have veins suitable for repeated blood sampling in subgroup only.
- Have maintained dietary habits and lifestyle within 3 months prior to screening and willing to maintain their habitual diets and lifestyle throughout the study.
- Agree to follow the restrictions on concomitant treatments as listed
- 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.
Who cannot join
- Individuals who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- 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).
- Current high fiber intake (estimated to be ≥ 30 g per day as estimated by a questionnaire at screening).
- 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.
- Experienced a change in body weight of ±4.5 kg (10 lbs.) over the 3 months prior to baseline.
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- Have eating disorder(s) (e.g., bulimia, binge eating disorder, etc.).
- Have medical condition(s) known to manifest gastrointestinal symptoms (e.g., irritable bowel syndrome, endometriosis, etc.).
- 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).
- 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).
- 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.
- Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
- Reports a clinically significant illness during the 28 days before the first dose of study product.
- Major surgery in 3 months prior to screening or planned major surgery during the study.
- 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.
- Currently, or plan to, live in the same household with another participant in the current study during the study period.
- 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.
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Boston Clinical Trials - Alcanza
Boston, Massachusetts, 02131
Indago Research Health Center,Inc.
Hileah, Florida, 33012
Vantage Clinical Trials, LLC
Tampa, Florida, 33614
About this study
Official title: 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.
Read the 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.
- Conditions
- Satiety, Appetite Regulation, Weight Control
- Being tested
- Arrabina Prebiotic 5.0 g, Arrabina Prebiotic 3.5 g, Placebo
- Keywords
- Satiety, Appetite, Weight Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arrabina Prebiotic 5.0 gDietary supplement
Active Powder
Arrabina Prebiotic 3.5 gDietary supplement
Active Powder
PlaceboOther
Placebo Powder
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not Active Powder per sachet Receives: Other: Placebo |
| Arrabina Prebiotic 5.0 g | Experimental | Active Arrabina Prebiotic 5.0 g fiber per sachet Receives: Dietary Supplement: Arrabina Prebiotic 5.0 g |
| Arrabina Prebiotic 3.5 g | Experimental | Active Arrabina Prebiotic 3.5 g fiber per sachet Receives: Dietary Supplement: Arrabina Prebiotic 3.5 g |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 - Fullness
Measured: 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
Measured: 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
Measured: Week 4
Secondary outcomes (46)
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
Measured: 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
Measured: 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 - Satiation
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start15 Apr 2025
- Primary completion20 Oct 2025
- Study completion20 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SatietyStudies 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
- Parallel groups
- Model description
- Randomized, Double-Blind, Parallel, 3-Arm, Placebo-Controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Comet Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
- Investigators
- Andrew Richard, Study director, Comet Biorefining Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06884449
- Sponsor's protocol ID
- C02-24-01-T0076
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2025
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Parallel, 3-Arm, Placebo-Controlled Study Evaluating the Effects of Arrabina on Satiety in Healthy Adults
- ClinicalTrials.gov ID
- NCT06884449
- Acronym / sponsor ID
- C02-24-01-T0076
- Conditions
- Satiety, Appetite Regulation, Weight Control
- Keywords
- Satiety, Appetite, Weight Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Comet Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- 20 Oct 2025 (actual)
- Study completion
- 20 Oct 2025 (actual)
- First posted
- 19 Mar 2025 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double-Blind, Parallel, 3-Arm, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboNot Active Powder per sachet |
| Arrabina Prebiotic 5.0 g | Experimental | Dietary Supplement: Arrabina Prebiotic 5.0 gActive Arrabina Prebiotic 5.0 g fiber per sachet |
| Arrabina Prebiotic 3.5 g | Experimental | Dietary Supplement: Arrabina Prebiotic 3.5 gActive Arrabina Prebiotic 3.5 g fiber per sachet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Generally healthy male and female participants who are between 18 - 65 years of age (inclusive).
- Have a body mass index (BMI) range of 25.0 - 29.9 kg/m2 (inclusive).
- Female participants must meet one of the following criteria:
- 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.
- Have veins suitable for repeated blood sampling in subgroup only.
Key exclusion criteria (18 listed)
- Individuals who are lactating, pregnant or planning to become pregnant during the study.
- Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients.
- 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).
- Current high fiber intake (estimated to be ≥ 30 g per day as estimated by a questionnaire at screening).
- 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.
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 |
|---|---|---|
| Arrabina Prebiotic 5.0 gActive Powder | Dietary supplement | Arrabina Prebiotic 5.0 g |
| Arrabina Prebiotic 3.5 gActive Powder | Dietary supplement | Arrabina Prebiotic 3.5 g |
| PlaceboPlacebo Powder | Other | Placebo |
Primary outcome
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 4
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.
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 4
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
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 4
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
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 4
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
46 secondary outcomes
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on body weight, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on eating behaviours, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on eating behaviours, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on eating behaviours, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on eating behaviors, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on gastrointestinal health, compared to placebo
Time frame: Week 4
To evaluate the effect of TP at two dose levels on gastrointestinal health, compared to placebo
Time frame: Week 12
To evaluate the effect of TP at two dose levels on mood, compared to placebo
Time frame: Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Andrew Richard study director
Comet Biorefining Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arrabina Prebiotic 5.0 g and Arrabina Prebiotic 3.5 g in people with Satiety and Appetite Regulation, run by Comet Bio Inc. at 3 sites in United States.
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 11 inclusion and 18 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: finished, as of the sponsor's last update on 19 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 3 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo (time frame: Week 4). The study lists 4 primary outcomes in all. 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 19 Feb 2026.