Saccharin and Acesulfame Potassium Consumption and Glucose Homeostasis in Older Adults With Prediabetes
1 other identifier
interventional
30
1 country
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 saccharin, but not acesulfame potassium, in middle-aged/older adults with prediabetes compared to a eucaloric diet with no NNS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 28, 2022
CompletedFirst Posted
Study publicly available on registry
July 1, 2022
CompletedStudy Start
First participant enrolled
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedApril 15, 2026
April 1, 2026
2.4 years
June 28, 2022
April 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
24-hour glycemic control
The area under the curve (AUC) glucose concentrations, mg/dl from the continuous glucose monitoring at baseline and follow-up will be used
6 weeks
Secondary Outcomes (7)
Oral glucose tolerance
6 weeks
Insulin Sensitivity
6 weeks
Serum Endotoxin
6 weeks
C-reactive protein
6 weeks
Tumor Necrosis Factor alpha
6 weeks
- +2 more secondary outcomes
Study Arms (3)
Acesulfame Potassium
ACTIVE COMPARATORControlled feeding study. Dosage of acesulfame potassium will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of acesulfame potassium for a 60 kg adult.
Saccharin
ACTIVE COMPARATORControlled feeding study. Dosage of saccharin will follow 25% of the acceptable daily intake (equivalent to 3.75 mg/kg). This amount represents 225 mg/day of saccharin for a 60 kg adult.
No NNS
PLACEBO COMPARATORcontrolled feeding study with no non-nutritive sweeteners
Interventions
Provision of either saccharin, acesulfame potassium, or control with no non-nutritive sweeteners to a controlled feeding study to determine impacts on glucose homeostasis.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Virginia Tech
Blacksburg, Virginia, 24061, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
June 28, 2022
First Posted
July 1, 2022
Study Start
September 21, 2023
Primary Completion
February 28, 2026
Study Completion
February 28, 2026
Last Updated
April 15, 2026
Record last verified: 2026-04
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).
De-identified study data will be posted to Virginia Tech's data repository, VTechData (https:// data.lib.vt.edu/). Datasets selected for sharing will be made accessible through VTechData, managed by the University Libraries at Virginia Tech. VTechData highlights, preserves, and provides access to data generated at Virginia Tech. The system relies on item/dataset level metadata as the primary building block to data discovery, access, and reuse. Published datasets are to be made accessible for at least five years.