A Placebo-Controlled Study Evaluating the Effects of Arra... | NCT06884449

NCT06884449

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.	NETWORK

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Arrabina Prebiotic 5.0 g	Dietary Supplement	Active Powder	Arrabina Prebiotic 5.0 g

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
To evaluate the effect of TP at two dose levels on appetite control, compared to placebo	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	Week 12

Other Outcomes

Measure	Description	Time Frame
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo	Changes from baseline to Week 4 in serum lipopolysaccharide binding protein (LBP), with each dose level of TP or placebo	Week 4
To evaluate the effect of TP at two dose levels on gut permeability, compared to placebo

Eligibility Module

Eligibility Criteria

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 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.

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).
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.
Currently, or plan to, live in the same household with another participant in the current study during the study period.
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.
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.

Facility	Status	City	State	ZIP	Country	Contacts
Indago Research Health Center,Inc.		Hileah	Florida	33012	United States
Vantage Clinical Trials, LLC