Effects of non-nutritive sweeteners on glucose control in older adults with prediabetes
Non-Nutritive Sweetener Consumption (Aspartame and Sucralose) and Glucose Homeostasis in Older Adults With Prediabetes
This study is testing whether using the sweetener sucralose can help older adults with prediabetes manage their blood sugar levels better than a regular diet without sweeteners.
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 | NCT05337098 on ClinicalTrials.gov |
What this trial studies
This study investigates how the consumption of non-nutritive sweeteners, specifically sucralose, affects glucose homeostasis in middle-aged and older adults with prediabetes. Participants will follow an 8-week diet that includes either sucralose or a eucaloric diet without non-nutritive sweeteners. The study aims to establish proof-of-concept for the impact of these sweeteners on glucose levels and related inflammatory markers. By comparing the effects of sucralose to aspartame and a control diet, the research seeks to clarify the role of non-nutritive sweeteners in glycemic control.
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 or those on diabetes medication will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into dietary recommendations for managing glucose levels in older adults with prediabetes.
How similar studies have performed: While some studies have explored the effects of non-nutritive sweeteners, this specific investigation into sucralose's impact on glucose homeostasis 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
- Principal investigator: Valisa Hedrick, PhD — Virginia Polytechnic Institute and State University
- 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.