COMPLETED

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

Conditions

Satiety Appetite Regulation Weight Control Appetite Weight Management

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is being conducted to assess the effects of a prebiotic product, Arrabina P, 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.

Official Title

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

Quick Facts

Study Start:2025-04-15

Study Completion:2025-10-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06884449

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Principal Investigator

Andrew Richard

STUDY_DIRECTOR

Comet Biorefining Inc.

Study Locations (Sites)

Indago Research Health Center,Inc.

Hialeah, Florida, 33012

United States

Vantage Clinical Trials, LLC

Tampa, Florida, 33614

United States

Boston Clinical Trials - Alcanza

Boston, Massachusetts, 02131

United States

Collaborators and Investigators

Sponsor: Comet Bio Inc.

Andrew Richard, STUDY_DIRECTOR, Comet Biorefining Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-15

Study Completion Date2025-10-28

Study Record Updates

Study Start Date2025-04-15

Study Completion Date2025-10-28

Terms related to this study

Keywords Provided by Researchers

Satiety
Appetite
Weight Management

Additional Relevant MeSH Terms

Satiety
Appetite Regulation
Weight Control