Insulin Sensitivity Clinical Trial
Official title:
Non-Nutritive Sweetener Consumption (Aspartame and Sucralose) and Glucose Homeostasis in Older Adults With Prediabetes
Animal and observational research in humans suggest that specific types of non-nutritive sweeteners (NNS) may impair glycemic control. However, whether NNS consumption impacts glucose homeostasis in middle-aged/older adults with prediabetes is unknown, and potential mechanisms by which this could occur have yet to be identified. The overall objective of this R21 proposal is to establish proof-of-concept for alterations in glucose homeostasis following intake of sucralose, but not aspartame, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Status | Recruiting |
Enrollment | 51 |
Est. completion date | February 28, 2025 |
Est. primary completion date | February 28, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: - Age 50+ years - Prediabetic (fasting glucose concentration of 100-125 mg/dL, 2-hour oral glucose tolerance test glucose concentration of 140-199 mg/dL, or a HbA1c value of 5.7% to 6.4%) - Weight stable for previous 6 months (±2 kg) - BMI <40 kg/m2 - Sedentary to recreationally active - No plans to gain/lose weight or change physical activity level - Willing to pick up food daily and consume foods provided for an 8-week period - Verbal and written informed consent - Approval by Medical Director - Consume less than one serving of non-nutritive sweetener per week Exclusion Criteria: - BMI >40 kg/m2 - Diabetes or diabetes medication - Antibiotic, prebiotic or prebiotic use in prior 3 months - Uncontrolled hypertension (blood pressure (BP) > 159/99 mmHg) - Diagnosed inflammatory bowel disease - Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease - Vegetarian or vegan - Pregnant or plans to become pregnant - Breastfeeding - Food allergies or aversions, Phenylketonuria (PKU) - Estrogen or testosterone usage |
Country | Name | City | State |
---|---|---|---|
United States | Virginia Tech | Blacksburg | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Polytechnic Institute and State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24-hour glycemic control | The area under the curve (AUC) glucose concentrations, mg/dl from the continuous glucose monitoring at baseline and follow-up will be used | 6 weeks | |
Secondary | Oral glucose tolerance | Oral glucose tolerance in response to 75 g glucose load; levels of glucose mg/dl will be determined 2 hrs after consuming a 75 glucose load | 6 weeks | |
Secondary | Insulin Sensitivity | Insulin uU/mL concentrations from the oral glucose tolerance test at baseline and follow-up will be used | 6 weeks | |
Secondary | Serum Endotoxin | Serum endotoxin mg/L concentrations will be measured at baseline and follow-up | 6 weeks | |
Secondary | C-reactive protein | C-reactive protein mg/dL concentrations will be measured at baseline and follow-up | 6 weeks | |
Secondary | Tumor Necrosis Factor alpha | Inflammatory cytokine: Tumor Necrosis Factor alpha pg/mL concentrations will be measured at baseline and follow-up | 6 weeks | |
Secondary | Interleukin 6 | Inflammatory cytokine: Interleukin 6 pg/mL concentrations will be measured at baseline and follow-up | 6 weeks | |
Secondary | Monocyte chemoattractant protein-1 | Inflammatory cytokine: Monocyte chemoattractant protein-1 pg/mL concentrations will be measured at baseline and follow-up | 6 weeks |
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