AzTrials
AzTrials

Continuous Glucose MonitoringNCT05337098

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

A study testing Non-Nutritive Sweetener Intake and impact on glucose homeostasis in people with Continuous Glucose Monitoring and Oral Glucose Tolerance, run by Virginia Polytechnic Institute and State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 40 years and older
What is being tested?
Non-Nutritive Sweetener Intake and impact on glucose homeostasis
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
1 siteUnited States
Study dates
18 Apr 2023to 28 Feb 2026
Phase
Interventional

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • Vegetarian or vegan
  • Pregnant or plans to become pregnant
  • Breastfeeding
  • Food allergies or aversions, Phenylketonuria (PKU)
  • Estrogen or testosterone usage

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Virginia Tech

    Blacksburg, Virginia, 24061

Other trials in United States

About this study

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

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.

Read the detailed description

Observational research has linked intake of non-nutritive sweeteners (NNS), which are consumed daily by ~50% of middle-aged/older U.S. adults, with increased risk of type 2 diabetes (T2D). This risk may be exacerbated by advancing age, which is associated with low-grade chronic inflammation and increased risk of T2D. Current T2D prevention recommendations related to NNS usage are unclear and confusing; use as an alternative to added sugar intake is suggested but long-term NNS use is discouraged despite minimal research to support this recommendation. Animal and observational human studies suggest detrimental effects of some NNS on glucose homeostasis. Longer-term human studies largely demonstrate null findings. Differences in study design and a lack of rigor in existing research contribute to inconclusive findings. In addition, NNS are often studied as a single entity yet types of NNS vary in their absorption and metabolism (e.g., the two most commonly consumed NNS, sucralose and aspartame). 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. We will investigate changes in inflammatory markers as potential mechanisms by which sucralose intake influences glucose homeostasis. Following a 2-week eucaloric lead-in diet, 30 middle-aged/older adults (40+ yrs) with prediabetes will be randomly assigned to 1 of 3 controlled feeding conditions for 6 weeks (10 participants per group): sucralose, aspartame, or a control group (no NNS). Standardized diets will be matched for macronutrients (50% carbohydrate, 35% fat, 15% protein) and other variables to avoid the potential confounds of weight change and dietary factors which may influence study outcomes (e.g., added sugars). All groups will receive identical diets, other than the additional NNS for the two NNS groups. 24-hr glycemic control using continuous glucose monitoring and insulin sensitivity and beta cell function via oral glucose tolerance test (OGTT), serum endotoxin, and inflammatory cytokines, including C-reactive protein, will be measured before and following the 6-week dietary treatment period. This research may have clinical practice and policy implications by informing U.S. dietary guidelines and guidelines for T2D prevention, which devote minimal attention to NNS and provide unclear guidance on NNS use due largely to a lack of rigorously-designed controlled feeding trials.

Being tested
Non-Nutritive Sweetener Intake and impact on glucose homeostasis
Medical subject headings
Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Nutritive Sweetener Intake and impact on glucose homeostasisOther

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

Study groups in NCT05337098
Study groupRoleWhat they receive
AspartameActive comparatorControlled 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.
Receives: Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis
SucraloseActive comparatorControlled 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.
Receives: Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis
No NNSSham comparatorControlled feeding study with no non-nutritive sweeteners.
Receives: Other: Non-Nutritive Sweetener Intake and impact on glucose homeostasis

What is being measured

The primary outcome is the main question the study is designed to answer.

  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".

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2022
  2. Study start18 Apr 2023
  3. Primary completion28 Feb 2026
  4. Study completion28 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05337098
Sponsor's protocol ID
1R21AG075344-01
Status last verified
Sep 2026
First submitted
4 Mar 2022
Last updated
24 Sep 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in