Actively Recruiting
Non-Nutritive Sweetener Consumption (Aspartame and Sucralose) and Glucose Homeostasis in Older Adults With Prediabetes
Led by Virginia Polytechnic Institute and State University · Updated on 2025-12-04
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Observational and animal studies suggest that certain non-nutritive sweeteners (NNS), like sucralose and aspartame, may affect blood sugar control, especially in middle-aged and older adults with prediabetes. This research aims to understand how these sweeteners impact glucose regulation and to explore possible inflammatory mechanisms involved. The study focuses on establishing proof-of-concept for changes in glucose homeostasis after consuming sucralose compared to aspartame and a no-sweetener diet in adults aged 40 and over with prediabetes. After a 2-week diet to stabilize eating habits, 30 participants will be randomly assigned to one of three groups for six weeks: a sucralose group, an aspartame group, or a control group with no NNS. All groups will follow diets matched in macronutrients and calories to avoid weight changes. The sweetener doses are set at 25% of acceptable daily intake levels for a 60 kg adult. The controlled feeding study ensures all participants consume the provided foods and sweeteners as assigned. Participants will be monitored using continuous glucose monitors to track 24-hour blood sugar control, and oral glucose tolerance tests will assess insulin sensitivity and beta cell function before and after the 6-week treatment. Inflammatory markers such as serum endotoxin, C-reactive protein, tumor necrosis factor alpha, interleukin 6, and monocyte chemoattractant protein-1 will also be measured. The study will last about eight weeks including the lead-in diet, and safety and adherence will be closely observed throughout.
CONDITIONS
Brief Title
Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 40 years or older
- Diagnosed with prediabetes based on fasting glucose, oral glucose tolerance test, or HbA1c levels
- Weight stable within plus or minus 2 kg for the past 6 months
- Body mass index less than 40 kg/m2
- Sedentary to recreationally active lifestyle
- No plans to gain or lose weight or change physical activity level
- Willing to pick up and consume provided foods daily for 8 weeks
- Able to provide verbal and written informed consent
- Approved by Medical Director
- Consume less than one serving of non-nutritive sweetener per week
You will not qualify if you...
- Body mass index greater than 40 kg/m2
- Diagnosed diabetes or use of diabetes medications
- Use of antibiotics, prebiotics, or probiotics within the prior 3 months
- Uncontrolled hypertension with blood pressure over 159/99 mmHg
- Diagnosed inflammatory bowel disease
- Past or current heart disease, stroke, respiratory disease, endocrine or metabolic disease, or blood-related cancer
- Vegetarian or vegan diet
- Pregnant, breastfeeding, or planning pregnancy
- Food allergies or aversions, or phenylketonuria (PKU)
- Use of estrogen or testosterone therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 weeks
Participants follow a 2-week eucaloric lead-in diet before starting the main dietary intervention.
Visits as needed to provide and monitor diet
Duration - 6 weeks
Participants consume controlled diets with either sucralose, aspartame, or no non-nutritive sweeteners for 6 weeks to assess effects on glucose homeostasis.
Daily food pick-up visits for 6 weeks
Trial Site Locations
Total: 1 location
1
Virginia Tech
Blacksburg, Virginia, United States, 24061
Actively Recruiting
Research Team
V
Valisa Hedrick, PhD
E
Elaina Marinik, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
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