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 range18 Years – 65 Years
SexALL
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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.
✕. 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).
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
✕. 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.).