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Search / Trial NCT05441982

Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes

Launched by VIRGINIA POLYTECHNIC INSTITUTE AND STATE UNIVERSITY · Jun 28, 2022

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how two non-nutritive sweeteners, saccharin and acesulfame potassium, affect blood sugar control in older adults who have prediabetes. Previous research has hinted that certain sweeteners might disrupt how the body manages glucose, but it's not clear how this happens or if it applies to older adults. The goal of the study is to find out if consuming saccharin, compared to a diet without any non-nutritive sweeteners, changes blood sugar levels in these individuals.

To participate in this trial, you should be at least 40 years old, have prediabetes, and be stable in your weight for the past six months. You should also be willing to follow the diet provided for eight weeks and not consume more than one serving of non-nutritive sweeteners per week. During the study, participants will receive daily food deliveries and will be monitored for changes in their blood sugar levels. It's important to note that individuals with diabetes, certain medical conditions, or those who are pregnant or breastfeeding cannot participate. This trial aims to provide valuable insights into how these sweeteners impact glucose control in older adults with prediabetes.

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

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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