Overweight and ObesityNCT05287906
A Trial to Assess Steviol Glycosides on Acute Appetite Hormone Release
A study testing Water, Glucose and Steviol Glycosides in people with Overweight and Obesity and Type 2 Diabetes Mellitus, run by Midwest Center for Metabolic and Cardiovascular Research at 3 sites in United States.
Trial summary
The objectives of this trial are to assess the effects of steviol glycoside alone or in combination with a glycemic carbohydrate on blood glucose and endocrine and gut hormone secretion vs. water and glucose in individuals with normal weight, overweight and type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity, Type 2 Diabetes Mellitus
- What is being tested?
- Water, Glucose and Steviol Glycosides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesUnited States
- Study dates
- 15 Apr 2022to 5 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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 any injectable 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 glycoside sweetened soft drinks per week for at least 1 month before screening.
- Consumption of less than 2 yogurts per week (that are sweetened with HIS).
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- Subject has a score of at least 7 on the Vein Access Scale.
- Subject is willing to follow his/her regular physical activity pattern throughout the 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 prior to each clinic visit.
- Subject is willing to refrain from vigorous physical activity for 24 h prior to each clinic visit. According to the World Health Organization (WHO), vigorous physical activity 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 clinic visit and has no plans to change smoking, vaping or other nicotine use habits during the study period
- Subject understands the study procedures and is willing to provide informed consent to participate in the study and authorization to release relevant protected health information to the study Investigator.
Who cannot join
- 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.
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- 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).
- Subject has used or has a condition likely to require the use of systemic corticosteroid drugs within 4 weeks of visit 1 (week -1).
- Subject has unstable use (initiation or dose alteration) of medications known to influence carbohydrate metabolism, including, but not limited to, adrenergic receptor blockers, thiazide diuretics, hypoglycemic medications, and/or antipsychotics within 4 weeks prior to visit 1 (week -1).
- Subject has used cannabidiol (CBD) products within two weeks prior to visit 2 (week 0) and throughout the study.
- Subject has a known allergy, sensitivity, or intolerance to any ingredients in the study beverages.
- 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 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, for drug or alcohol abuse. Alcohol abuse is defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1 ½ oz distilled spirits).
- Subject has a history of a diagnosed eating disorder (e.g., anorexia nervosa or bulimia 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 her ability to provide informed consent or comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Great Lakes Clinical Trials
Chicago, Illinois, 60625
Excellence Medical and Research
Miami Gardens, Florida, 33169
Advanced Research for Health Improvement
Naples, Florida, 34102
About this study
Official title: The Effects of Steviol Glycosides on Acute Appetite Hormone Release in Men and Women with Normal Weight, Overweight and Type 2 Diabetes
The objectives of this trial are to assess the effects of steviol glycoside alone or in combination with a glycemic carbohydrate on blood glucose and endocrine and gut hormone secretion vs. water and glucose in individuals with normal weight, overweight and type 2 diabetes mellitus (T2DM).
- Conditions
- Overweight and Obesity, Type 2 Diabetes Mellitus
- Being tested
- Water, Glucose, Steviol Glycosides, Steviol Glycosides plus glucose, Rebaudioside A
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterOther
Each subject will receive one control and three treatments in the crossover design. The control contains water only.
GlucoseOther
Each subject will receive one control and three treatments in the crossover design. The glucose contains water and glucose.
Steviol GlycosidesOther
Each subject will receive one control and three treatments in the crossover design. The Steviol Glycoside beverage contains water and steviol glycosides.
Steviol Glycosides plus glucoseOther
Each subject will receive one control and three treatments in the crossover design. The Steviol Glycoside plus glucose beverage contains water, glucose, and steviol glycosides.
Rebaudioside AOther
A leaf-based, extracted stevia product to compare to the Eversweet in the normal weight group only. The Rebaudioside A contains water and rebaudioside A.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Water; Other: Glucose; Other: Steviol Glycosides; Other: Steviol Glycosides plus glucose; Other: 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. Receives: Other: Water; Other: Glucose; Other: Steviol Glycosides; Other: Steviol Glycosides plus glucose |
| Type 2 Diabetes Mellitis Group | Experimental | The T2DM group includes men and women with BMI 25.0 - 34.9 kg/m2, HbA1c <8%, and will receive all interventions. Receives: Other: Water; Other: Glucose; Other: Steviol Glycosides; Other: Steviol Glycosides plus glucose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin
Changes or percent changes from baseline to the end of treatment
Measured: 4 weeks
Glucose
Changes or percent changes from baseline to the end of treatment
Measured: 4 weeks
Glucagon
Changes or percent changes from baseline to the end of treatment
Measured: 4 weeks
Peptide YY
Changes or percent changes from baseline to the end of treatment
Measured: 4 weeks
Glucagon-like peptide 1
Changes or percent changes from baseline to the end of treatment
Measured: 4 weeks
Gastric inhibitory polypeptide
Changes or percent changes from baseline to the end of treatment
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start15 Apr 2022
- Primary completion5 Jun 2024
- Study completion5 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overweight and ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular Research
- Sponsor type
- University, hospital or other
- Collaborators
- Cargill
- Responsible party
- Sponsor
- Investigators
- Kevin Maki, PhD, Study director, MB Clinical Research & Consulting, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287906
- Sponsor's protocol ID
- MB-2110
- Status last verified
- Sep 2024
- First submitted
- 10 Mar 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42680068
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Steviol Glycosides on Acute Appetite Hormone Release in Men and Women with Normal Weight, Overweight and Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05287906
- Acronym / sponsor ID
- MB-2110
- Conditions
- Overweight and Obesity, Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Midwest Center for Metabolic and Cardiovascular ResearchUniversity, hospital or other
- Collaborators
- Cargill
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 5 Jun 2024 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of this trial are to assess the effects of steviol glycoside alone or in combination with a glycemic carbohydrate on blood glucose and endocrine and gut hormone secretion vs. water and glucose in individuals with normal weight, overweight and type 2 diabetes mellitus (T2DM).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Weight Group | Experimental | Other: Water, Other: Glucose, Other: Steviol Glycosides, Other: Steviol Glycosides plus glucose, Other: Rebaudioside AThe normal weight group incudes men and women with BMI 18.5 - 24.9 kg/m2, and will receive all interventions. |
| Overweight Group | Experimental | Other: Water, Other: Glucose, Other: Steviol Glycosides, Other: Steviol Glycosides plus glucoseThe overweight group includes men and women with BMI 25.0 - 29.9 kg/m2, and will receive all interventions. |
| Type 2 Diabetes Mellitis Group | Experimental | Other: Water, Other: Glucose, Other: Steviol Glycosides, Other: Steviol Glycosides plus glucoseThe T2DM group includes men and women with BMI 25.0 - 34.9 kg/m2, HbA1c <8%, and will receive all interventions. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 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 any injectable 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 glycoside sweetened soft drinks per week for at least 1 month before screening.
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterEach subject will receive one control and three treatments in the crossover design. The control contains water only. | Other | Normal Weight Group, Overweight Group, Type 2 Diabetes Mellitis Group |
| GlucoseEach subject will receive one control and three treatments in the crossover design. The glucose contains water and glucose. | Other | Normal Weight Group, Overweight Group, Type 2 Diabetes Mellitis Group |
| Steviol GlycosidesEach subject will receive one control and three treatments in the crossover design. The Steviol Glycoside beverage contains water and steviol glycosides. | Other | Normal Weight Group, Overweight Group, Type 2 Diabetes Mellitis Group |
| Steviol Glycosides plus glucoseEach subject will receive one control and three treatments in the crossover design. The Steviol Glycoside plus glucose beverage contains water, glucose, and steviol glycosides. | Other | Normal Weight Group, Overweight Group, Type 2 Diabetes Mellitis Group |
| Rebaudioside AA leaf-based, extracted stevia product to compare to the Eversweet in the normal weight group only. The Rebaudioside A contains water and rebaudioside A. | Other | Normal Weight Group |
Primary outcome
Insulin
Time frame: 4 weeks
Changes or percent changes from baseline to the end of treatment
Glucose
Time frame: 4 weeks
Changes or percent changes from baseline to the end of treatment
Glucagon
Time frame: 4 weeks
Changes or percent changes from baseline to the end of treatment
Peptide YY
Time frame: 4 weeks
Changes or percent changes from baseline to the end of treatment
Glucagon-like peptide 1
Time frame: 4 weeks
Changes or percent changes from baseline to the end of treatment
Gastric inhibitory polypeptide
Time frame: 4 weeks
Changes or percent changes from baseline to the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 42680068Scott 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Maki, PhD study director
MB Clinical Research & Consulting, LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Water, Glucose and Steviol Glycosides in people with Overweight and Obesity and Type 2 Diabetes Mellitus, run by Midwest Center for Metabolic and Cardiovascular Research at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05287906, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.