Actively Recruiting

Phase Not Applicable
Age: 40Years +
All Genders
NCT05337098

Non-Nutritive Sweetener Consumption 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

149 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official 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
  • Prediabetic with fasting glucose 100-125 mg/dL, 2-hour oral glucose tolerance test 140-199 mg/dL, or HbA1c 5.7% to 6.4%
  • Weight stable within plus or minus 2 kg for the past 6 months
  • Body mass index (BMI) less than 40 kg/m2
  • Sedentary to recreationally active lifestyle
  • No plans to gain or lose weight or change physical activity during the study
  • Willing to pick up and eat only provided study foods daily for 8 weeks
  • Able to provide verbal and written informed consent
  • Approval by Medical Director
  • Consumes less than one serving of non-nutritive sweetener per week
Not Eligible

You will not qualify if you...

  • Body mass index (BMI) greater than 40 kg/m2
  • Diagnosis of diabetes or use of diabetes medication
  • Use of antibiotics, prebiotics, or probiotics in the past 3 months
  • Uncontrolled high blood pressure (greater than 159/99 mmHg)
  • Diagnosed inflammatory bowel disease
  • Past or current heart disease, stroke, respiratory disease, endocrine or metabolic disease, or blood cancers
  • Vegetarian or vegan diet
  • Pregnant or planning to become pregnant
  • Breastfeeding
  • Food allergies, food aversions, or phenylketonuria (PKU)
  • Use of estrogen or testosterone therapy

AI-Screening

AI-Powered Screening

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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

CONTACT

E

Elaina Marinik, PhD

CONTACT

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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