Effects of saccharin and acesulfame potassium on glucose levels in older adults with prediabetes
Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
This study is testing whether using non-nutritive sweeteners like saccharin and acesulfame potassium affects blood sugar levels in older adults with prediabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Virginia Polytechnic Institute and State University Academic / other |
| Locations | 1 site (Blacksburg, Virginia) |
| Trial ID | NCT05441982 on ClinicalTrials.gov |
What this trial studies
This study investigates how the consumption of non-nutritive sweeteners, specifically saccharin and acesulfame potassium, affects glucose homeostasis in middle-aged and older adults with prediabetes. Participants will follow an 8-week diet where they will consume foods provided by the researchers, with a focus on understanding the impact of saccharin compared to a eucaloric diet without non-nutritive sweeteners. The study aims to clarify the potential mechanisms by which these sweeteners may influence glucose metabolism and inflammation in this population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 40 and older who are prediabetic and have a stable weight.
Not a fit: Patients with diabetes, a BMI over 40, or those on specific medications or with certain health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations for older adults with prediabetes, potentially improving glucose management and reducing the risk of type 2 diabetes.
How similar studies have performed: While some observational studies have suggested potential negative effects of non-nutritive sweeteners on glucose control, this specific approach focusing on saccharin and acesulfame potassium in older adults with prediabetes is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 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
Where this trial is running
Blacksburg, Virginia
- Virginia Tech — Blacksburg, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Valisa Hedrick, PhD
- Email: vhedrick@vt.edu
- Phone: 540-231-7983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.