Arrabina P for Satiety

No longer recruiting at 3 trial locations

Overseen By Stephanie Recker

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Comet Bio Inc.

Disqualifiers: Diabetes, Hypertension, Eating disorders, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a prebiotic product called Arrabina P can help manage appetite and support gut health in healthy adults. Participants will receive either a dose of Arrabina P or a placebo to assess its effects on hunger levels and overall weight management. The trial seeks generally healthy individuals with a body mass index between 25.0 and 29.9 who regularly eat breakfast and are not following specific diets. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance dietary health strategies.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must agree to follow any restrictions on treatments as listed by the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Arrabina P is gentle on the stomach. Studies have found it does not cause discomfort or bloating. Made from natural fibers, Arrabina P supports gut health. It has also been studied for its role in controlling appetite and managing weight. Overall, users tolerate Arrabina P well, with no major reports of side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for managing satiety rely on dietary changes or appetite suppressants. However, Arrabina P stands out because it is a prebiotic fiber that promotes satiety through gut health. Researchers are excited about Arrabina P because it uses a natural mechanism by enhancing beneficial gut bacteria, potentially improving digestion and fullness without relying on chemicals or stimulants. This makes it a unique, gut-friendly approach compared to traditional methods. Additionally, Arrabina P comes in easy-to-use sachets, providing a convenient way to support healthy eating habits.

What evidence suggests that Arrabina P is effective for appetite regulation?

Research shows that Arrabina P, a type of prebiotic, might help control appetite and manage weight. Prebiotics serve as food for beneficial gut bacteria, promoting their growth and function. This can influence feelings of fullness after eating. Early results suggest that Arrabina P can improve gut health, which relates to better appetite control. Although studies on Arrabina P's direct effects on appetite are still developing, research on prebiotics is encouraging. This trial will test different dosages of Arrabina P, specifically 5.0 g and 3.5 g, to evaluate their effects on satiety. Many believe this could be a natural way to manage hunger and support weight goals. ^{1 2 6 7 8}

Who Is on the Research Team?

Andrew Richard

Principal Investigator

Comet Biorefining Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults interested in managing their appetite and supporting gut health, potentially aiding weight management. Specific eligibility criteria are not provided, but typically participants should be free from significant health issues that could affect the study's outcome.

Inclusion Criteria

Participants must agree to follow restrictions on concomitant treatments, adhere to study requirements, give voluntary consent, understand questionnaires, and carry out study procedures

Participants must consume food in the morning daily and agree to consume a standardized high-carbohydrate breakfast at specified visits

Participants must have maintained dietary habits and lifestyle for 3 months prior to screening and throughout the study

Exclusion Criteria

Lactating, pregnant, or planning pregnancy during the study

Known sensitivity, intolerability, or allergy to study products, excipients, or rescue medications

Participation in weight management programs, recent significant weight change, or eating disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Arrabina P Prebiotic or placebo to assess effects on appetite and other health parameters

12 weeks

Regular visits for assessments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Arrabina P

Trial Overview The study tests two different doses of Arrabina P Prebiotic (3.5 g and 5.0 g) against a placebo to see if they can help control hunger and support digestive wellness in healthy individuals.

How Is the Trial Designed?

Group I: Arrabina P Prebiotic 5.0 g Experimental Treatment 1 Intervention

Active Arrabina P Prebiotic 5.0 g fiber per sachet

Group II: Arrabina P Prebiotic 3.5 g Experimental Treatment 1 Intervention

Active Arrabina P Prebiotic 3.5 g fiber per sachet

Group III: Placebo Placebo Group 1 Intervention

Not Active Powder per sachet

Who Is Running the Clinical Trial?

Comet Bio Inc.

Lead Sponsor

Trials

2

Recruited

180+

Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Collaborator

Trials

40

Recruited

2,400+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06884449

A Placebo-Controlled Study Evaluating the Effects of ... 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 ...

2. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06884449/a-placebo-controlled-study-evaluating-the-effects-of-arrabina-p-on-satiety-in-healthy-adults

A Placebo-Controlled Study Evaluating the Effects of ... This study is being conducted to assess the effects of a prebiotic product, Arrabina P, on appetite in healthy adults.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06884449?term=AREA%5BBasicSearch%5D(AREA%5BSponsorSearch%5D(COVERAGE%5BFullMatch%5DEXPANSION%5BNone%5D(%22Comet%20Bio%20Inc.%22)))&rank=1

A Placebo-Controlled Study Evaluating the Effects of Arrabina P ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

4. withpower.com withpower.com/trial/arrabina-p-for-satiety-3be79

Arrabina P for Satiety · Info for Participants 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 ...

5. indagoresearch.org indagoresearch.org/studies/clinicaltrial-prebiotic-arrabina/

Clinical trial evaluating the effects of a natural prebiotic ... You may qualify for a clinical trial evaluating the effects of a natural prebiotic (Arrabina®P) on appetite, mood, sleep, and more!

6. comet-bio.com comet-bio.com/

Arrabina Prebiotic Ingredients for Manufacturers – Comet ... With a low effective dose and superior solubility, Arrabina can be incorporated into a wide array of products—from ready-to-mix beverages to functional bars— ...

7. healthnutritionhub.givaudan.com healthnutritionhub.givaudan.com/ingredients/arrabina-p

Arrabina™-P Arrabina™-P is a complex of naturally-occurring dietary fibres derived from wheat, specifically designed to gently support gut health.

8. newswire.ca newswire.ca/news-releases/comet-bio-awarded-by-frost-amp-sullivan-for-its-arrabina-tm-prebiotic-fiber-815902933.html

Comet Bio Awarded by Frost & Sullivan for its Arrabina™ ... Though effective at a low inclusion rate, Arrabina is clinically proven to be gentle on the stomach and not cause the discomfort or bloating ...