Phase
Condition
Diabetes Prevention
Weight Loss
Non-ulcer Dyspepsia (Nud)
Treatment
High Fiber Bar with Inulin
High Fiber bar with Fiber Blend
High Fiber Bar with Resistant Starch type 4
Clinical Study ID
Ages 25-64 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female 25 to 64 years of age, inclusive. There will be approximately equalnumbers of men and women.
Individual has a self-reported BMI of 18.5 to 39.9 kg/m2, inclusive.
Individual has been taking tirzepatide (≥10 mg weekly injection), semaglutide (≥2.0mg weekly injection), or liraglutide (≥2.4 mg daily injection) for at least 4 weeksand plans to continue to take it throughout the duration of the study.
Individual has attained a high school diploma or a General Educational Development (GED) equivalent.
Individual has not participated in another research study within 30 days of thescreening visit.
Individual is willing and able to undergo the scheduled study procedures.
Individual understands the study procedures and signs forms documenting informedconsent to participate in the study and authorization for release of relevantprotected health information to the study Investigator.
Exclusion
Exclusion Criteria:
Individual has a clinically significant medical condition that, in the opinion ofthe Investigator, could interfere with the interpretation of the study results.Health conditions may include history or presence of clinically important GI,cardiac, renal, hepatic, endocrine, pulmonary, biliary, pancreatic, or neurologicaldisorders that may affect the participant's ability to adhere to the study protocoland/or affect study outcomes, in the judgment of the Investigator. Clinicallyimportant GI conditions included but are not limited to: inflammatory bowel disease,irritable bowel syndrome, gastroparesis, clinically important lactose intolerance.
Individual habitually consumes >8 g fiber per 1000 kcal per day.
Individual had a recent (within two weeks of screening) episode of acute GI illnesssuch as nausea, vomiting, or diarrhea.
Individual has a history of frequent diarrhea or constipation prior to beginningGLP-1 receptor agonist that, in the opinion of the Investigator, could interferewith the interpretation of the study results.
Individual has a history of stomach or GI surgery (e.g., gastric bypass,cholecystectomy) that in the opinion of the Investigator, could interfere withevaluation of the study outcomes.
Individual uses medications (over-the counter or prescription) or dietarysupplements known to influence gastrointestinal motility including laxatives,enemas, or suppositories; prokinetic drugs; anti-diarrheal agents, anti-spasmotics;fiber supplements; and prebiotic and probiotic supplements (Appendix 6). A 14-daywashout phase prior to day 1 is allowed for participants taking any of theseproducts.
Daily use of non-steroidal anti-inflammatory drugs (NSAIDs).
Individual has a history of cancer in the prior 2 years, except non-melanoma skincancer or carcinoma in situ of the cervix.
Individual has a history of a diagnosed eating disorder (e.g., anorexia or bulimianervosa).
History of any major trauma or major surgical event within 2 months of visit 1.
Use of tobacco/nicotine products (e.g., cigarette smoking, vaping, chewing tobacco)within 12 months of visit 1.
Use of hemp/marijuana products within 12 months of visit 1. Occasional use (e.g.,once or twice a month) within 12 months of visit 1 is allowed but requires at leasta 14-day washout prior to day 1 and the participant must be willing to refrain fromuse during the study.
Individual is a female who is pregnant, planning to be pregnant during the studyperiod, lactating, or is of childbearing potential and is unwilling to commit to theuse of a medically approved form of contraception throughout the study period.
Individual has an allergy, sensitivity, or intolerance to any foods.
Individual has extreme dietary habits (e.g., vegan, Atkins diet, etc.).
Individual has signs or symptoms of an active infection of clinical significance orhas taken antibiotics within 10 days prior to any visit (washout is permitted forre-scheduling of a visit).
Individual has a current or recent history (past 12 months of screening) or strongpotential for illicit drug or excessive alcohol intake defined as >14 drinks perweek (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
Individual has been exposed to any non-registered drug product within 30 days priorto screening.
Individual has a condition the Investigator believes would interfere with his or herability to provide informed consent, comply with the study protocol, or which mightconfound the interpretation of the study results or put the person at undue risk.
Study Design
Connect with a study center
Excellence Medical and Research
Miami Gardens, Florida 33169
United StatesActive - Recruiting
Health Awareness
Port St Lucie, Florida 34952
United StatesActive - Recruiting
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