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Search / Trial NCT05337098

Non-Nutritive Sweetener Consumption and Glucose Homeostasis in Older Adults With Prediabetes

Launched by VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY · Apr 19, 2022

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is exploring how certain non-nutritive sweeteners, specifically sucralose and aspartame, affect blood sugar control in older adults who have prediabetes. Previous studies suggest that these sweeteners might disrupt how the body manages glucose (a type of sugar) but it is not yet clear how they impact people aged 50 and older. The goal is to see if consuming sucralose changes blood sugar levels compared to a diet without any sweeteners.

To participate in the trial, you need to be at least 50 years old, be diagnosed with prediabetes, and have a stable weight over the last six months. You should not have diabetes or certain other health conditions, and you must be willing to follow a specific diet that includes daily meals provided to you for eight weeks. This study is a great opportunity to contribute to our understanding of how sweeteners might affect health, while also receiving support with your dietary needs during the trial.

Gender

ALL

Eligibility 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

About Virginia Polytechnic Institute And State University

Virginia Polytechnic Institute and State University, commonly known as Virginia Tech, is a leading public research university renowned for its commitment to innovation and excellence in education. With a strong emphasis on interdisciplinary collaboration, Virginia Tech fosters advancements in various fields, including health sciences and engineering. The university actively engages in clinical research to address pressing health challenges, leveraging its state-of-the-art facilities and expert faculty to conduct rigorous clinical trials. Through its initiatives, Virginia Tech aims to enhance patient care and contribute to the scientific community's understanding of diverse health issues.

Locations

Blacksburg, Virginia, United States

Patients applied

0 patients applied

Trial Officials

Valisa Hedrick, PhD

Principal Investigator

Virginia Polytechnic Institute and State University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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