A Trial to Assess Steviol Glycosides on Acute Appetite Hormone Release

NCT05287906 | Completed

• 1 other identifier: MB-2110
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief 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).

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

  4 weeks

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: 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.

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.

Other: Water; Other: Glucose; Other: Steviol Glycosides; Other: Steviol Glycosides plus glucose

Interventions

Water OTHER

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

Normal Weight Group; Overweight Group; Type 2 Diabetes Mellitis Group

Glucose OTHER

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

Normal Weight Group; Overweight Group; Type 2 Diabetes Mellitis Group

Steviol Glycosides OTHER

Each subject will receive one control and three treatments in the crossover design. The Steviol Glycoside beverage contains water and steviol glycosides.

Normal Weight Group; Overweight Group; Type 2 Diabetes Mellitis Group

Steviol Glycosides plus glucose OTHER

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.

Normal Weight Group; Overweight Group; Type 2 Diabetes Mellitis Group

Rebaudioside A OTHER

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.

Normal Weight Group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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.
• 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).
• 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.

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).

Sponsors & Collaborators

• Midwest Center for Metabolic and Cardiovascular Research: lead
• Cargill: collaborator

Study Sites (3)

Excellence Medical and Research

Miami Gardens, Florida, 33169, United States

Location

Advanced Research for Health Improvement

Naples, Florida, 34102, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60625, United States

Location

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2

Interventions

Water; Glucose; rebaudioside A

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Kevin Maki, PhD

  MB Clinical Research & Consulting, LLC

  STUDY DIRECTOR

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
• Primary Completion: June 5, 2024
• Study Completion: June 5, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)