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Sweetener

Steviol Glycosides for Obesity

N/A
Waitlist Available
Research Sponsored by Midwest Center for Metabolic and Cardiovascular Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has BMI 18.5 to 24.9 kg/m2 for the normal weight group.
Subject has BMI 25.0 to 29.9 kg/m2 for the overweight group.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial is testing the effects of steviol glycoside, a sugar substitute, on blood sugar, hormones, and gut function in people with normal weight, overweight, and type 2 diabetes.

Who is the study for?
This trial is for men and women aged 18-50 with different body weights: normal (BMI 18.5-24.9), overweight (BMI 25.0-29.9), or type 2 diabetes patients with BMI up to 34.9 and HbA1c <8%. Participants should have a low intake of sweetened drinks, not be on certain medications, and willing to avoid alcohol, vigorous exercise, tobacco use before visits.Check my eligibility
What is being tested?
The study tests the effects of steviol glycosides alone or combined with glucose on blood sugar levels and hormone release compared to water and glucose in individuals who are normal weight, overweight, or have type 2 diabetes.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial, participants may experience changes in appetite hormones which could affect hunger levels or gastrointestinal discomfort due to the ingestion of various test substances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have a normal weight based on your height and weight.
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You are in the overweight range based on your weight and height.
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You have a body mass index (BMI) between 25.0 and 34.9, your HbA1c level is less than 8%, and you are not taking injectable diabetes medication or a specific type of oral medication.
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You eat fewer than 2 sweetened yogurts with a sugar substitute per week.
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Your vein access score is at least 7.
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You have been drinking less than 670 mL (24 oz) of artificially sweetened or steviol glycoside sweetened soft drinks per week for at least 1 month before screening.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gastric inhibitory polypeptide
Glucagon
Glucagon-like peptide 1
+3 more

Side effects data

From 2014 Phase 4 trial • 106 Patients • NCT02054325
51%
Hyperpigmentation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Polidocanol With Glucose
Glucose

Trial Design

3Treatment groups
Experimental Treatment
Group I: Type 2 Diabetes Mellitis GroupExperimental Treatment4 Interventions
The T2DM group includes men and women with BMI 25.0 - 34.9 kg/m2, HbA1c <8%, and will receive all interventions.
Group II: Overweight GroupExperimental Treatment4 Interventions
The overweight group includes men and women with BMI 25.0 - 29.9 kg/m2, and will receive all interventions.
Group III: Normal Weight GroupExperimental Treatment5 Interventions
The normal weight group incudes men and women with BMI 18.5 - 24.9 kg/m2, and will receive all interventions.

Find a Location

Who is running the clinical trial?

Midwest Center for Metabolic and Cardiovascular ResearchLead Sponsor
20 Previous Clinical Trials
783 Total Patients Enrolled
CargillIndustry Sponsor
26 Previous Clinical Trials
3,120 Total Patients Enrolled
Kevin Maki, PhDStudy DirectorMB Clinical Research & Consulting, LLC
12 Previous Clinical Trials
997 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What site did they apply to?
Great Lakes Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Trial to Assess Steviol Glycosides on Acute Appetite Hormone Release
2022. "A Trial to Assess Steviol Glycosides on Acute Appetite Hormone Release". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05287906.
~0 spots leftby May 2024
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