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Completed

NCT Number: NCT07506577

Impact of Saccharin and Acesulfame-Potassium on Glycemia

The major purpose of this research project is to learn if consuming artificial sweeteners have any impact on glucose levels in adults at high risk for developing type 2 diabetes. People may be at risk for diabetes if you are a middle-aged or older adult. Briefly, the full study is 3 weeks long with 3 controlled feeding visits. Which means participants will eat all of the food and drinks that we provide to them for breakfast. Participants will come to the lab in the morning to eat breakfast, and we will monitor changes in blood glucose over a 2 hour period. Participants will be randomized into 1 of 3 groups: 1 group will receive acesulfame-potassium, 1 group will receive saccharin, and 1 group will receive no artificial sweeteners. Participants will experience a different group each visit, with about 7 days between each visit. We will be examining if consuming artificial sweeteners has any impact on glucose levels.

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Key information

Conditions

PreDiabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Prediabetic State

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Tech

Blacksburg, Virginia, 24061, United States

About this study

The study will utilize a randomized 3 period crossover design, with 3 instances of controlled feeding. The overall objective of this study is to establish proof-of-concept for impaired glycemic control and insulin sensitivity, but no alterations following aspartame intake, in middle-aged/older adults with prediabetes. We aim to enroll 14 middle-aged/older adults (40+ years) with prediabetes. Participants will be randomly assigned to 1 of 3 controlled feeding conditions for 3 separate visits: acesulfame-potassium, saccharin, or control, each separated by a week. All participants will have been assigned to each artificial sweetener once by the end of the study. All test conditions will receive an identical breakfast, with the exception of the sweetener type. Glucose tolerance and insulin sensitivity will be measured directly after each controlled feeding.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 40+ years
  • Prediabetic
  • Weight stable for previous 6 months
  • BMI <40 kg/m2
  • Sedentary to recreationally active
  • No plans to gain/lose weight or change physical activity level
  • Consume less than one serving of non-sugar sweeteners per week

Exclusion criteria

  • Diabetes or any diabetes medications
  • Antibiotic, prebiotic or prebiotic use in prior 3 months
  • Blood pressure (BP) > 159/99 mmHg
  • Change in type or dose of these prescription medications over the past 6 months: antihypertensive medications, Statins, hormone replacement therapy (estrogen or testosterone) or oral contraceptives, thyroid medications
  • 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)

Treatment and study plan

non-sugar sweetener - saccharin

Other

Participants will receive 7.5 mg/kg of body weight of saccharin

non-sugar sweetener - acesulfame potassium

Other

Participants will receive 7.5 mg/kg of body weight of acesulfame potassium

Non-sugar sweetener - control

Other

Participants will receive 240 mg of dextrose as the control.

Primary outcomes

  1. Glucose tolerance

    Time frame: 120 minutes

    assessment of glucose concentrations over a 120 minute period

Secondary outcomes

  1. Insulin

    Time frame: 120 minutes

    assessment of insulin sensitivity over a 2 hour time period

Sponsors and collaborators

Lead sponsor

Virginia Polytechnic Institute and State University

Other

Registry information

Official study title

Acute Impact of Saccharin and Acesulfame-Potassium Consumption and Glucose Levels in Middle-Aged and Older Adults With Prediabetes

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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