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

NCT06884449 | Completed

• 1 other identifier: C02-24-01-T0076
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Weight Control; Satiety; Appetite Regulation

Keywords

Satiety; Appetite; Weight Management

Outcome Measures

Primary Outcomes (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 - 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 - Satiation

  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

Secondary Outcomes (46)

• To evaluate the effect of TP at two dose levels on appetite control, compared to placebo

  Week 12

• To evaluate the effect of TP at two dose levels on appetite control, compared to placebo

  Week 12

• To evaluate the effect of TP at two dose levels on appetite control, compared to placebo

  Week 12

• To evaluate the effect of TP at two dose levels on appetite control, compared to placebo

  Week 12

• To evaluate the effect of TP at two dose levels on body weight, compared to placebo

  Week 12

Other Outcomes (54)

• To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo

  Week 4

• To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo

  Week 12

• To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo

  Week 4

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Not Active Powder per sachet

Other: Placebo

Arrabina Prebiotic 5.0 g

EXPERIMENTAL

Active Arrabina Prebiotic 5.0 g fiber per sachet

Dietary Supplement: Arrabina Prebiotic 5.0 g

Arrabina Prebiotic 3.5 g

EXPERIMENTAL

Active Arrabina Prebiotic 3.5 g fiber per sachet

Dietary Supplement: Arrabina Prebiotic 3.5 g

Interventions

Placebo OTHER

Placebo Powder

Placebo

Arrabina Prebiotic 5.0 g DIETARY_SUPPLEMENT

Active Powder

Arrabina Prebiotic 5.0 g

Arrabina Prebiotic 3.5 g DIETARY_SUPPLEMENT

Active Powder

Arrabina Prebiotic 3.5 g

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nutrasource Pharmaceutical and Nutraceutical Services, Inc.: collaborator
• Comet Bio Inc.: lead

Study Sites (3)

Indago Research Health Center,Inc.

Hileah, Florida, 33012, United States

Location

Vantage Clinical Trials, LLC

Tampa, Florida, 33614, United States

Location

Boston Clinical Trials - Alcanza

Boston, Massachusetts, 02131, United States

Location

Study Officials

• Andrew Richard

  Comet Biorefining Inc.

  STUDY DIRECTOR

Study Design

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

Model Details: Randomized, Double-Blind, Parallel, 3-Arm, Placebo-Controlled

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: April 15, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)