Phase
Condition
Weight Loss
Treatment
Arrabina P Prebiotic 3.5 g
Arrabina P Prebiotic 5.0 g
Placebo
Clinical Study ID
Ages 18-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
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 24-32days for participants in the main group and 26-32 days for participants in thesubgroup and demonstrated during the screening period
No longer menstruate due to medication (e.g., those taking birth control shotslike 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 astandardized high-carbohydrate breakfast within 15 minutes at Visit 2, Visit 3 andVisit 4.
Have veins suitable for repeated blood sampling in subgroup only.
Have maintained dietary habits and lifestyle within 3 months prior to screening andwilling 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 thequestionnaires, and carry out all study-related procedures.
Exclusion
Exclusion Criteria:
Individuals who are lactating, pregnant or planning to become pregnant during thestudy.
Have a known sensitivity, intolerability, or allergy to any of the study products ortheir excipients.
Have Type I diabetes or Type II diabetes, high blood pressure (≥140 systolic or ≥90diastolic mmHg), or uncontrolled thyroid disease ("uncontrolled" defined as beingunmedicated, 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 uncontrolledconditions).
Current high fiber intake (estimated to be ≥ 30 g per day as estimated by aquestionnaire 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 managementprogram 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 tobaseline.
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 renalfailure), 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 situcervical cancer) with recovery occurred within 5 years before the screening visit.
Are receiving treatments for or have been hospitalized in the last 12 months forpsychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.).
Reports a clinically significant illness during the 28 days before the first dose ofstudy product.
Major surgery in 3 months prior to screening or planned major surgery during thestudy.
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-patientintervention program) or use that to the opinion of the investigator may be of aconcern for the study.
Currently, or plan to, live in the same household with another participant in thecurrent study during the study period.
Current enrolment or past participation in another study with any product(s) with atleast one active ingredient within 28 days before first dose of study product orlonger, if the previous test product is deemed by the investigator to have lastingeffects that might influence the eligibility criteria or outcomes of current study.
Any other medical condition/situation or use of medications/supplements/therapiesthat, in the opinion of the investigator, may adversely affect the participant'sability to participate in the study or its measures or pose a significant risk tothe participant.
Study Design
Study Description
Connect with a study center
Indago Research Health Center,Inc.
Hialeah, Florida 33012
United StatesActive - Recruiting
Indago Research Health Center,Inc.
Hileah, Florida 33012
United StatesSite Not Available
Vantage Clinical Trials, LLC
Tampa, Florida 33614
United StatesActive - Recruiting
Boston Clinical Trials - Alcanza
Boston, Massachusetts 02131
United StatesActive - Recruiting
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