Appetite Regulation, Satiety, Weight Control
Conditions
Keywords
Satiety, Appetite, Weight Management
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.
Detailed description
This is a randomized, double-blind, parallel, 3-arm, placebo-controlled study to assess the effects of Arrabina Prebiotic on satiety in healthy adults. The primary goal of this study is to assess how two different doses of Arrabina affect self-reported appetite. Secondary goals include evaluating weight control, eating behaviors, mood, sleep quality, and memory. The product is expected to support beneficial gut bacteria, help maintain lipid levels, and promote digestive comfort and appetite regulation.
Interventions
DIETARY_SUPPLEMENTArrabina Prebiotic 5.0 g
Active Powder
DIETARY_SUPPLEMENTArrabina Prebiotic 3.5 g
Active Powder
OTHERPlacebo
Placebo Powder
Sponsors
Comet Bio Inc.
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Randomized, Double-Blind, Parallel, 3-Arm, Placebo-Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion 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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of TP at two dose levels on appetite control, compared to placebo | Week 4 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the effect of TP at two dose levels on appetite control, compared to placebo | Week 12 | Change from baseline to Week 12 in iAUC of the following self-reported appetite sensations, with each sensation measured using a 100 mm VAS over 4 hours after the consumption of a standardized high-carbohydrate breakfast - Hunger |
| To evaluate the effect of TP at two dose levels on body weight, compared to placebo | Week 12 | Percent change from baseline to Week 12 in body weight |
| To evaluate the effect of TP at two dose levels on eating behaviours, compared to placebo | Week 4 | Change from baseline to Week 4 in eating behaviors as assessed by the following questionnaires 2 hours after the consumption of a standardized high-carbohydrate breakfast - Three-Factor Eating Questionnaire (TFEQ) |
| To evaluate the effect of TP at two dose levels on eating behaviors, compared to placebo | Week 12 | Change from baseline to Week 12 in eating behaviors' as assessed by the following questionnaires 2 hours after the consumption of a standardized high-carbohydrate breakfast - Food Craving Questionnaire-Trait (FCQ-T) |
| To evaluate the effect of TP at two dose levels on blood lipid biomarkers, compared to placebo | Week 4 | Change from baseline to Week 4 in the following blood lipid biomarkers in fasting blood samples with each dose level of TP or placebo: Total Cholesterol |
| To evaluate the effect of TP at two dose levels on microbiota composition, compared to placebo | Week 4 | Change from baseline to Week 4 stool sample in the abundance of the following beneficial microbes: Bifidobacteriaceae (B.longum) as assessed by 16s RNA sequencing |
| To evaluate the effect of TP at two dose levels on gastrointestinal health, compared to placebo | Week 4 | Changes from baseline to Week 4 in gastrointestinal symptoms rating scales (GSRS) |
| To evaluate the effect of TP at two dose levels on mood, compared to placebo | Week 4 | Changes from baseline to Week 4 in mood state as assessed by the Brunel Mood Scale Questionnaire (BRUMS-24) total mood disturbance score and sub-scales |
| To evaluate the effect of TP at two dose levels on sleep quality, compared to placebo | Week 4 | Changes from baseline to Week 4 in sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) |
| To evaluate the effect of TP at two dose levels on memory, compared to placebo | Week 4 | Changes from baseline to Week 4 in memory as assessed by Multifactorial Memory Questionnaire (MMQ) |
| Subgroup only: To evaluate the effect of TP at two dose levels on postprandial glucose and insulin response, compared to placebo | Week 4 | Changes from baseline to Week 4 in the postprandial profile of glucose and insulin over 4 hours after a standardized high-carbohydrate breakfast with each dose level of TP or placebo |
Countries
United States
Contacts
STUDY_DIRECTORAndrew Richard
Comet Biorefining Inc.
Outcome results
None listed