Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
ID05337098

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

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Run-in Period

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

Treatment

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

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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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