Recruiting

Non-Nutritive Sweeteners

Sponsor:

Virginia Polytechnic Institute and State University

Code:

NCT05337098

Conditions

Continuous Glucose Monitoring

Oral Glucose Tolerance

Insulin Sensitivity

Inflammatory Markers

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Non-Nutritive Sweetener Intake and impact on glucose homeostasis

Study Details

Brief summary:

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 sucralose, but not aspartame, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.

Conditions

Continuous Glucose Monitoring

Oral Glucose Tolerance

Insulin Sensitivity

Inflammatory Markers

Study ID

NCT05337098

Start date

Apr 18, 2023

Status verified date

Dec, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Aspartame

Controlled feeding study. Dosage of aspartame will follow 25% of the acceptable daily intake (equivalent to 12.5 mg/kg for aspartame). This amount represents 750 mg/day of aspartame for a 60 kg adult.

active comparator: Sucralose

Controlled feeding study. Dosage of sucralose will follow 25% of the acceptable daily intake (equivalent to 1.25 mg/kg for sucralose). This amount represents 75 mg/day of sucralose for a 60 kg adult.

sham comparator: No NNS

Controlled feeding study with no non-nutritive sweeteners.

Interventions

Non-Nutritive Sweetener Intake and impact on glucose homeostasis

Provision of either aspartame, sucralose, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.

Primary outcome measure

  • 24-hour glycemic control [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Valisa Hedrick, PhD

540-231-7983vhedrick@vt.edu

Elaina Marinik, PhD

540-231-0923emarinik@vt.edu

Locations

Virginia Tech

Recruiting

Blacksburg, Virginia, United States, 24061

More Information

Sponsor

Virginia Polytechnic Institute and State University

Last update posted

Dec 4, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Polytechnic Institute and State University on 2025-12-04.