Trials Sponsors Conditions Drugs Pricing

Conditions

Overweight and Obesity Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (6)

Insulin
Changes or percent changes from baseline to the end of treatment
4 weeks
Glucose
Changes or percent changes from baseline to the end of treatment
4 weeks
Glucagon
Changes or percent changes from baseline to the end of treatment
4 weeks
Peptide YY
Changes or percent changes from baseline to the end of treatment
4 weeks
Glucagon-like peptide 1
Changes or percent changes from baseline to the end of treatment
4 weeks
Gastric inhibitory polypeptide
Changes or percent changes from baseline to the end of treatment

Study Arms (3)

Normal Weight Group

EXPERIMENTAL

The normal weight group incudes men and women with BMI 18.5 - 24.9 kg/m2, and will receive all interventions.

Other: WaterOther: GlucoseOther: Steviol GlycosidesOther: Steviol Glycosides plus glucoseOther: Rebaudioside A

Overweight Group

EXPERIMENTAL

The overweight group includes men and women with BMI 25.0 - 29.9 kg/m2, and will receive all interventions.

Other: WaterOther: Glucose

Interventions

WaterOther

Each subject will receive one control and three treatments in the crossover design. The control contains water only.

Normal Weight GroupOverweight GroupType 2 Diabetes Mellitis Group

GlucoseOther

Each subject will receive one control and three treatments in the crossover design. The glucose contains water and glucose.

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

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.

Sponsors & Collaborators

Cargill
Industrycollaborator
Midwest Center for Metabolic and Cardiovascular Research
Otherlead

Study Sites (3)

Excellence Medical and Research

Miami Gardens, Florida, 33169, United States

Advanced Research for Health Improvement

Naples, Florida, 34102, United States

Great Lakes Clinical Trials

Chicago, Illinois, 60625, United States

Related Publications (1)

Scott CE, Adams CG, Williamson P, Hutton TK, Wilcox ML, Guarneiri LL, Maki KC. Acute Stevia Consumption Does Not Alter Endocrine Responses in Individuals with Normal Weight, Overweight, and Type 2 Diabetes Mellitus. J Nutr. 2026 Sep 1:101814. doi: 10.1016/j.tjnut.2026.101814. Online ahead of print.
PMID: 42680068DERIVED

MeSH Terms

Conditions

OverweightObesityDiabetes Mellitus, Type 2

Interventions

WaterGlucoserebaudioside A

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism Disorders

Study Officials

Kevin Maki, PhD
MB Clinical Research & Consulting, LLC
STUDY DIRECTOR

Enrollment

69 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: CROSSOVER
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 10, 2022

First Posted

March 18, 2022

Study Start

April 15, 2022

Actual (reported)

You may not qualify if:

Subject has a laboratory test result of clinical significance in the opinion of the study Investigator at visit 1 (week -1).
Subject has atherosclerotic cardiovascular disease including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease \[symptomatic (e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin) or \>50% stenosis on angiography or ultrasound\] 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 the study results.
Individual has a positive urine drug screen for illicit drugs.
Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic 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 skin cancer or carcinoma in situ of the cervix.
Subject has history of moderate or severe renal failure, moderate or severe liver disease, gall bladder removal, pancreatic disease, or a gastrointestinal disorder that might influence the digestion or absorption of nutrients or impact colonic function as judged by the Investigator.
Subject has history of major trauma or a major medical or surgical event requiring hospitalization within 3 months of visit 1 (week -1).
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.
Subject has an active infection or has used antibiotics within 7 d of any test visit. Those with an active infection and/or using antibiotics must wait at least 7 d after the infection resolves or antibiotic use is complete. The test period will be extended for completion in these cases.
Subject has experienced a change in body weight of ±4.5 kg (\~10 pounds) over the 3 months prior to visit 1 (week -1).
Subject has unstable use (initiation or dose alteration) of any antihypertensive medication within 4 weeks prior to visit 1 (week -1).
Subject has unstable use (initiation or dose alteration) of any of the following lipid-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 convertase subtilisin 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/or supplements) within 4 weeks of visit 1 (week -1).
+10 more criteria

A Trial to Assess Steviol Glycosides on Acute Appetite Hormone Release

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Study Arms (3)

Normal Weight Group

Overweight Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Type 2 Diabetes Mellitis Group

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (6)

Study Arms (3)

Normal Weight Group

Overweight Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Type 2 Diabetes Mellitis Group

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations