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

NCT05337098 | Completed Results

• 1 other identifier: 1R21AG075344-01
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

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

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

Outcome Measures

Primary Outcomes (1)

• Continuous Glucose Monitoring AUC

  mg\*hr/dL of glucose via continuous glucose monitoring (Area under the curve, AUC). Participants wore a CGM device for 7 consecutive days prior to pre-intervention testing and 7 consecutive days prior to post-intervention testing. Interstitial glucose concentrations were recorded every 5 minutes.The AUC was measured prior to beginning the controlled feeding for 1 week (during the lead-in phase) and during the last week of the controlled feeding intervention. This was not measured for a certain time frame "post-dose".

  Pre-intervention CGM AUC was measured for 7 days (last week of 2 week lead in) prior to being randomized into the 4 week intervention. Post-intervention CGM AUC was measured for 7 days during the last week of the 4 week intervention.

Study Arms (3)

Aspartame

ACTIVE COMPARATOR

Controlled feeding study. Dosage of aspartame will follow 25% of the acceptable daily intake (equivalent to 12.5 mg/kg for aspartame). This amount represents 750 mg/day of aspartame for a 60 kg adult.

Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis

Sucralose

ACTIVE COMPARATOR

Controlled feeding study. Dosage of sucralose will follow 25% of the acceptable daily intake (equivalent to 1.25 mg/kg for sucralose). This amount represents 75 mg/day of sucralose for a 60 kg adult.

Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis

No NNS

SHAM COMPARATOR

Controlled feeding study with no non-nutritive sweeteners.

Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis

Interventions

Non-Nutritive Sweetener Intake and impact on glucose homeostasis OTHER

Provision of either aspartame, sucralose, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.

Aspartame; No NNS; Sucralose

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24061, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Valisa Hedrick
• Organization: Virginia Tech

vhedrick@vt.edu

5402317983

Study Officials

• Valisa Hedrick, PhD

  Virginia Polytechnic Institute and State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2022
• First Posted: April 20, 2022
• Study Start: April 18, 2023
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: September 24, 2026
• Results First Posted: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available following completion of the trial and will be available for at least 5 years
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

US (1)