Glycemic Impact of NNS Via the Gut Microbiome

NCT07868432 | Enrolling By Invitation

• 1 other identifier: STUDY00007045
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will evaluate the feasibility and acceptability of a 30-day sucralose intervention among adults with prediabetes. Participants will consume six commercial sucralose (Splenda®) packets daily for 30 days while wearing a blinded continuous glucose monitor (CGM). Oral glucose tolerance tests (OGTTs) with blood draws will be performed at baseline and after 30 days to assess glucose incremental area under the curve (iAUC). Stool samples will also be collected to assess the feasibility of microbiome sample collection for future studies. The study will generate preliminary data to inform the design of a larger randomized clinical trial examining the effects of non-nutritive sweeteners on glucose homeostasis and the gut microbiome.

Conditions

Prediabetes

Keywords

Prediabetes; sucralose; non-nutritive sweeteners; continuous glucose monitoring; gut microbiome; oral glucose tolerance test

Outcome Measures

Primary Outcomes (8)

• Recruitment feasibility

  Number and proportions of participants reached, eligible, agreeing to participate, and enrolled, plus time required to enroll 10 participants.

  Enrollment period

• Change in OGTT glucose iAUC

  Change in glucose incremental area under the curve during oral glucose tolerance testing from baseline to Day 30.

  Baseline and Day 30

• Retention feasibility

  Percentage of enrolled participants who attend the post-intervention visit.

  Day 30

• Intervention adherence

  Percentage of daily consumption surveys completed, percentage of assigned packets consumed by self-report, and agreement with packet counts.

  Days 1-30

• OGTT acceptability

  Frequency of IV line failure or venous intolerance and intolerance of the OGTT beverage.

  Baseline and Day 30

• CGM acceptability

  Completion of 30-day CGM wear, sensor failures, and percentage of possible glucose data points captured.

  Days 1-30

• Diet and activity recall acceptability

  Time needed to complete each 24-hour dietary and physical activity recall.

  Baseline and Day 30

• Stool collection acceptability

  Percentage of participants who complete both planned stool sample collections.

  Baseline through Day 30

Secondary Outcomes (2)

• Time in range

  Days 1-30

• Glycemic variability

  Days 1-30

Study Arms (1)

Sucralose Intervention

EXPERIMENTAL

Participants will consume six Splenda® packets daily for 30 days.

Dietary Supplement: Sucralose

Interventions

Sucralose DIETARY_SUPPLEMENT

Sucralose (Splenda®): six commercial tabletop packets daily, totaling 72 mg sucralose per day, for 30 days.

Sucralose Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c measured within the past 6 months between 5.7% and 6.4%.
• eGFR measured within the past 6 months of at least 45 mL/min/1.73 m².
• Prediabetes defined by diagnosis code R73.0 or a subcategory.
• Age 35 years or older.
• BMI of at least 25 kg/m².
• Low non-nutritive sweetener use, defined as less than once per week.

You may not qualify if:

• Type 1 diabetes.
• Type 2 diabetes.
• History of bariatric surgery.
• History of organ or tissue transplantation.
• Current GLP-1 agonist treatment.
• Current metformin treatment.
• Current oral steroid medication.
• Current immunosuppressant use, including tacrolimus, cyclosporine, mycophenolate mofetil, prednisone, methylprednisolone, sirolimus, or everolimus.
• Severe gastrointestinal disease, at the discretion of the PI and physician Co-Investigator.
• Severe comorbidities with poor physical or mental function that may prevent completion of study procedures, at the discretion of the PI and physician Co-Investigator.
• Current or planned pregnancy or lactation.
• Self-reported non-nutritive sweetener allergy or intolerance.
• Regular consumption of non-nutritive sweetener products, defined as once per week or more often.
• Concurrent participation in another study involving dietary changes, investigational drugs, or microbiome-altering agents.

Sponsors & Collaborators

• Tufts University: lead
• Tufts Medical Center: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

trichlorosucrose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Meng Wang

  Food is Medicine Institute, Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: October 5, 2026
• First Posted: October 9, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: October 9, 2026

Record last verified: 2026-10

Locations

US (1)