Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
Running, not enrolling · Not applicable
Conditions studied: Continuous Glucose Monitoring, Oral Glucose Tolerance, Insulin Sensitivity, Inflammatory Markers
In brief
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 saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Key facts
- Study ID
- NCT05441982
- Run by
- Virginia Polytechnic Institute and State University
- People needed
- 30
- Starts
- 2023-09-21
- Expected to finish
- 2026-11-30
- Last updated by the study team
- 2026-06-10
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 40+ 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
You may not qualify if…
- 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
Where it is running
- Virginia Tech — Blacksburg, Virginia, United States
Full record on ClinicalTrials.gov
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