Investigating the Effects of Steviol Glycosides on Acute Appetite Hormone Release in Men and Women with Normal Weight, Overweight, and Type 2 Diabetes!
Attention men and women aged 18-50 years! We're thrilled to announce a groundbreaking study examining the effects of Steviol Glycosides on acute appetite hormone release. This research aims to shed light on the potential benefits of Steviol Glycosides in managing appetite and weight-related concerns.
What are Steviol Glycosides?
Steviol Glycosides are natural compounds extracted from the Stevia plant. Known for their intense sweetness, these non-caloric sweeteners are gaining attention for their potential role in sugar reduction strategies and potential health benefits.
Study Details:
We are currently seeking participants to join our study investigating the effects of Steviol Glycosides on acute appetite hormone release. Men and women aged 18-50 years with normal weight, overweight, and type 2 diabetes are encouraged to participate. The study aims to evaluate how Steviol Glycosides influence appetite hormones and their impact on individuals with varying weight and diabetes status.
Inclusion Criteria:
To be eligible for participation, individuals should meet the following criteria:
1️⃣ Male or female, aged 18-50 years.
2️⃣ For the normal weight group: BMI between 18.5 to 24.9 kg/m², inclusive.
3️⃣ For the overweight group: BMI between 25.0 to 29.9 kg/m², inclusive.
4️⃣ For individuals with type 2 diabetes mellitus: BMI between 25.0 to 34.9 kg/m², HbA1c < 8%, and not taking any injectable hypoglycemic medication(s) or oral GLP-1 mimetic(s).
5️⃣ Subject has consumed 600 mL (20 oz) of artificially sweetened or Steviol Glycoside sweetened soft drinks per week for at least 1 month before screening.
6️⃣ Consumption of less than 2 servings of food or beverage per week that are sweetened with high-intensity sweeteners (HIS).
7️⃣ Subject has a score of at least 7 on the Vein Access Scale.
8️⃣ Subject is willing to follow their regular physical activity pattern throughout the study period.
9️⃣ Subject is willing to refrain from consuming marijuana throughout the study period.
🔟 Subject is willing to refrain from the consumption of alcoholic beverages for 48 hours prior to each clinic visit.
1️⃣1️⃣ Subject is willing to refrain from vigorous physical activity for 24 hours prior to each clinic visit, as defined by the World Health Organization (WHO).
1️⃣2️⃣ Subject understands the study procedures and is willing to provide informed consent to participate in the study and authorize the release of relevant protected health information to the study investigator.
Exclusion Criteria:
Participants who meet any of the following criteria will not be eligible for participation:
1️⃣ Subject has a laboratory test result of clinical significance in the opinion of the study physician at screening (visit 1).
2️⃣ Subject has atherosclerotic cardiovascular disease, including clinical signs of atherosclerosis or other forms of clinical atherosclerotic disease.
3️⃣ 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 the study results.
4️⃣ Individual has a positive urine drug screen for illicit drugs.
5️⃣ Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at visit 1 (week -1).
6️⃣ Subject has a history of cancer in the prior 5 years, except for non-melanoma skin cancer or carcinoma in situ of the cervix.
7️⃣ Subject has a history of moderate or severe renal failure, moderate or severe liver disease, gall bladder removal, pancreatic disease, or gastrointestinal disorder that might influence nutrient digestion or absorption.
8️⃣ Subject has used antibiotics within 4 weeks of visit 1 (week -1) or has a condition likely to require the use of antibiotics during the study.
9️⃣ Subject has an active infection or has used antibiotics within 7 days of any test visit.
1️⃣0️⃣ Subject has experienced a change in body weight of ≥4.5 kg (~10 pounds) over the 3 months prior to visit 1 (week -1).
1️⃣1️⃣ Subject has unstable use of any antihypertensive medication within 4 weeks prior to visit 1 (week -1).
1️⃣2️⃣ Subject has unstable use of lipid-altering medications within 4 weeks prior to visit 1 (week -1).
1️⃣3️⃣ Subject has a history of major trauma or major medical or surgical event requiring hospitalization within 3 months of visit 1 (week -1).
1️⃣4️⃣ Subject has unstable use of a proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor within 3 months of visit 1 (week -1).
1️⃣5️⃣ Subject has used weight-loss drugs within 4 weeks of visit 1 (week -1).
1️⃣6️⃣ Subject has used or has a condition likely to require the use of systemic corticosteroid drugs within 4 weeks of visit 1 (week -1).
1️⃣7️⃣ Subject has unstable use of medications known to influence carbohydrate metabolism within 4 weeks prior to visit 1 (week -1).
1️⃣8️⃣ Subject has used cannabidiol (CBD) products within two weeks prior to visit 2 (week 0) and throughout the study.
1️⃣9️⃣ Subject uses tobacco or nicotine products.
2️⃣0️⃣ Subject has a known allergy, sensitivity, or intolerance to any ingredients in the study beverages.
2️⃣1️⃣ Subject is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and unwilling to commit to the use of medically approved contraception throughout the study period.
2️⃣2️⃣ Subject has extreme dietary habits.
2️⃣3️⃣ Subject has a current or recent history of drug or alcohol abuse.
2️⃣4️⃣ Subject has a history of a diagnosed eating disorder.
2️⃣5️⃣ Subject has been exposed to any non-registered drug product within 30 days of visit 1 (week -1).
2️⃣6️⃣ Subject has a condition that may interfere with their ability to provide informed consent or comply with the study protocol, or might confound the interpretation of the study results or put the person at undue risk.
Benefits of Participating:
1️⃣ Contribution to scientific research: Help expand our understanding of Steviol Glycosides' effects on appetite hormone release, leading to potential advancements in appetite management strategies.
2️⃣ Personalized health insights: Gain valuable knowledge about your own appetite regulation and potential benefits of Steviol Glycosides in your specific weight and diabetes status.
3️⃣ Potential impact on future interventions: Your participation may contribute to the development of new approaches for managing appetite and weight-related concerns in individuals with different metabolic conditions.
How to Participate:
If you meet the study criteria or want to learn more about this exciting study, please contact our research team at 786-320-5229. Our team will provide you with all the necessary details and guide you through the enrollment process.
Join us in unraveling the potential benefits of Steviol Glycosides in managing appetite and weight-related concerns. Your participation can make a significant impact on the future of nutrition research and help shape the development of new strategies for appetite regulation.
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