RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Non-Nutritive Sweetener Consumption (Aspartame and Sucralose) and Glucose Homeostasis in Older Adults With Prediabetes

Quick Facts

Study Start:2023-04-18
Study Completion:2025-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05337098

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 50+ years
  2. * 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%)
  3. * Weight stable for previous 6 months (±2 kg)
  4. * BMI \<40 kg/m2
  5. * Sedentary to recreationally active
  6. * No plans to gain/lose weight or change physical activity level
  7. * Willing to pick up food daily and consume foods provided for an 8-week period
  8. * Verbal and written informed consent
  9. * Approval by Medical Director
  10. * Consume less than one serving of non-nutritive sweetener per week
  1. * BMI \>40 kg/m2
  2. * Diabetes or diabetes medication
  3. * Antibiotic, prebiotic or prebiotic use in prior 3 months
  4. * Uncontrolled hypertension (blood pressure (BP) \> 159/99 mmHg)
  5. * Diagnosed inflammatory bowel disease
  6. * Past or current heart diseases, stroke, respiratory disease, endocrine or metabolic disease, or hematological-oncological disease
  7. * Vegetarian or vegan
  8. * Pregnant or plans to become pregnant
  9. * Breastfeeding
  10. * Food allergies or aversions, Phenylketonuria (PKU)
  11. * Estrogen or testosterone usage

Contacts and Locations

Study Contact

Valisa Hedrick, PhD
CONTACT
540-231-7983
vhedrick@vt.edu
Elaina Marinik, PhD
CONTACT
540-231-0923
emarinik@vt.edu

Principal Investigator

Valisa Hedrick, PhD
PRINCIPAL_INVESTIGATOR
Virginia Polytechnic Institute and State University

Study Locations (Sites)

Virginia Tech
Blacksburg, Virginia, 24061
United States

Collaborators and Investigators

Sponsor: Virginia Polytechnic Institute and State University

  • Valisa Hedrick, PhD, PRINCIPAL_INVESTIGATOR, Virginia Polytechnic Institute and State University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-18
Study Completion Date2025-02-28

Study Record Updates

Study Start Date2023-04-18
Study Completion Date2025-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Continuous Glucose Monitoring
  • Oral Glucose Tolerance
  • Insulin Sensitivity
  • Inflammatory Markers