A Placebo-Controlled Study Evaluating the Effects of Arrabina on Satiety in Healthy Adults (NCT06884449) | Clinical Trial Compass
CompletedNot Applicable
A Placebo-Controlled Study Evaluating the Effects of Arrabina on Satiety in Healthy Adults
United States135 participantsStarted 2025-04-15
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
. 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.
Exclusion criteria
. Individuals who are lactating, pregnant or planning to become pregnant during the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Timeframe: Week 4
2
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Timeframe: Week 4
3
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
Timeframe: Week 4
4
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo
. 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.).