Phase
Condition
Diabetes Mellitus, Type 2
Hypertriglyceridemia
Obesity
Treatment
Steviol Glycosides
Water
Steviol Glycosides plus glucose
Clinical Study ID
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject is male or female and is 18-50 years of age, inclusive.
Subject has BMI 18.5 to 24.9 kg/m2, inclusive, for the normal weight group.
Subject has BMI 25.0 to 29.9 kg/m2, inclusive, for the overweight group.
Subject has BMI 25.0 to 34.9 kg/m2, inclusive, and HbA1c <8%, and is not taking anyinjectable hypoglycemic medication(s) or oral glucagon-like peptide 1 (GLP-1)mimetic(s), for individuals with T2DM.
Subject has consumed ≤670 mL (24 oz) of artificially sweetened or steviol glycosidesweetened soft drinks per week for at least 1 month before screening.
Consumption of less than 2 yogurts per week (that are sweetened with HIS).
Subject has a score of at least 7 on the Vein Access Scale.
Subject is willing to follow his/her regular physical activity pattern throughoutthe study period.
Subject is willing to refrain from consuming marijuana throughout the study period.
Subject is willing to refrain from consumption of alcoholic beverages for 48 h priorto each clinic visit.
Subject is willing to refrain from vigorous physical activity for 24 h prior to eachclinic visit. According to the World Health Organization (WHO), vigorous physicalactivity may include running, fast cycling, fast swimming, or moving heavy objects.
Subject is willing to abstain from tobacco use 1 h prior to and during each clinicvisit and has no plans to change smoking, vaping or other nicotine use habits duringthe study period
Subject understands the study procedures and is willing to provide informed consentto participate in the study and authorization to release relevant protected healthinformation to the study Investigator.
Exclusion
Exclusion Criteria:
Subject has a laboratory test result of clinical significance in the opinion of thestudy Investigator at visit 1 (week -1).
Subject has atherosclerotic cardiovascular disease including any of the following:clinical signs of atherosclerosis including peripheral arterial disease, abdominalaortic aneurysm, carotid artery disease [symptomatic (e.g., myocardial infarction,angina, transient ischemic attack or stroke of carotid origin) or >50% stenosis onangiography or ultrasound] or other forms of clinical atherosclerotic disease (e.g.,renal artery disease).
Subject has a history or presence of a clinically important medical condition that,in the opinion of the Investigator, could interfere with the interpretation of thestudy results.
Individual has a positive urine drug screen for illicit drugs.
Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/ordiastolic blood pressure ≥100 mm Hg) at visit 1 (week -1).
Subject has a history of cancer in the prior 5 years, except for non-melanoma skincancer or carcinoma in situ of the cervix.
Subject has history of moderate or severe renal failure, moderate or severe liverdisease, gall bladder removal, pancreatic disease, or a gastrointestinal disorderthat might influence the digestion or absorption of nutrients or impact colonicfunction as judged by the Investigator.
Subject has history of major trauma or a major medical or surgical event requiringhospitalization within 3 months of visit 1 (week -1).
Subject has used antibiotics within 4 weeks of visit 1 (week -1) or has a conditionlikely to require the use of antibiotics during the study.
Subject has an active infection or has used antibiotics within 7 d of any testvisit. Those with an active infection and/or using antibiotics must wait at least 7d after the infection resolves or antibiotic use is complete. The test period willbe extended for completion in these cases.
Subject has experienced a change in body weight of ±4.5 kg (~10 pounds) over the 3months prior to visit 1 (week -1).
Subject has unstable use (initiation or dose alteration) of any antihypertensivemedication within 4 weeks prior to visit 1 (week -1).
Subject has unstable use (initiation or dose alteration) of any of the followinglipid-altering medications within 4 weeks prior to visit 1 (week -1): statins,ezetimibe, bempedoic acid, bile acid sequestrants, fibrates, niacin (drug form),and/or omega-3 fatty acid drugs.
Subject has unstable use (initiation or dose alteration) of a proprotein convertasesubtilisin kexin type 9 (PCSK9) inhibitor within 3 months of visit 1 (week -1).
Subject has used weight-loss drugs (including over-the-counter medications and/orsupplements) within 4 weeks of visit 1 (week -1).
Subject has used or has a condition likely to require the use of systemiccorticosteroid drugs within 4 weeks of visit 1 (week -1).
Subject has unstable use (initiation or dose alteration) of medications known toinfluence carbohydrate metabolism, including, but not limited to, adrenergicreceptor blockers, thiazide diuretics, hypoglycemic medications, and/orantipsychotics within 4 weeks prior to visit 1 (week -1).
Subject has used cannabidiol (CBD) products within two weeks prior to visit 2 (week
- and throughout the study.
Subject has a known allergy, sensitivity, or intolerance to any ingredients in thestudy beverages.
Subject is a female who is pregnant, planning to be pregnant during the studyperiod, lactating, or is of childbearing potential and unwilling to commit to theuse of a medically approved form of contraception throughout the study period.
Subject has extreme dietary habits (e.g., vegan or very low carbohydrate diet).
Subject has a current or recent history (past 12 months), or strong potential, fordrug or alcohol abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12oz beer, 5 oz wine, or 1 ½ oz distilled spirits).
Subject has a history of a diagnosed eating disorder (e.g., anorexia nervosa orbulimia nervosa).
Subject has been exposed to any non-registered drug product within 30 d of visit 1 (week -1).
Subject has a condition the Investigator believes would interfere with his or herability to provide informed consent or comply with the study protocol, or whichmight confound the interpretation of the study results or put the person at unduerisk.
Study Design
Connect with a study center
Excellence Medical and Research
Miami Gardens, Florida 33169
United StatesSite Not Available
Advanced Research for Health Improvement
Naples, Florida 34102
United StatesSite Not Available
Great Lakes Clinical Trials
Chicago, Illinois 60625
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.