Acute Impact of Non-Sugar Sweeteners (Sucralose and Aspartame)

NCT07506564 | Completed

• 1 other identifier: 22-507
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The major purpose of this research project is to learn if consuming artificial sweeteners have any impact on glucose levels in adults at high risk for developing type 2 diabetes. People may be at risk for diabetes if you are a middle-aged or older adult. Briefly, the full study is 3 weeks long with 3 controlled feeding visits. Which means participants will eat all of the food and drinks that we provide to them for breakfast. Participants will come to the lab in the morning to eat breakfast, and we will monitor changes in blood glucose over a 2 hour period. Participants will be randomized into 1 of 3 groups: 1 group will receive aspartame (Equal), 1 group will receive sucralose (Splenda), and 1 group will receive no artificial sweeteners. Participants will experience a different group each visit, with about 7 days between each visit. We will be examining if consuming artificial sweeteners has any impact on glucose levels.

Conditions

Prediabetes

Keywords

controlled feeding; non-sugar sweeteners; prediabetes

Outcome Measures

Primary Outcomes (1)

• glucose tolerance

  changes in glucose concentrations

  120 minutes

Secondary Outcomes (1)

• insulin

  120 minutes

Study Arms (3)

Sucralose Arm

ACTIVE COMPARATOR

Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing their respective sweetener, and capsules containing the same sweetener. For the sucralose arm, participants receive 50% of the ADI (2.5 mg/kg). Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.

Other: non-sugar sweeteners - Sucralose

Aspartame Arm

ACTIVE COMPARATOR

Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing their respective sweetener, and capsules containing the same sweetener. For the aspartame arm, participants receive 50% of the ADI (25 mg/kg). Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.

Other: non-sugar sweetener - aspartame

Control Arm

PLACEBO COMPARATOR

Controlled feeding: Participants will be provided a standardized breakfast, a beverage containing no non-sugar sweetener, and capsules containing dextrose. Blood glucose and insulin will be measured at 0 minutes and every 30 minutes for 120 minutes post breakfast.

Other: Non-sugar sweetener - control

Interventions

non-sugar sweeteners - Sucralose OTHER

Participants will be given 2.5 mg/kg of body weight of sucralose

Also known as: Sucralose

Sucralose Arm

non-sugar sweetener - aspartame OTHER

Participants will receive 25 mg/kg body weight of aspartame

Aspartame Arm

Non-sugar sweetener - control OTHER

Participants will receive 340 mg of dextrose

Control Arm

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
• Weight stable for previous 6 months
• BMI \<40 kg/m2
• Sedentary to recreationally active
• No plans to gain/lose weight or change physical activity level
• Consume less than one serving of non-sugar sweeteners per week

You may not qualify if:

• Diabetes or any diabetes medications
• Antibiotic, prebiotic or prebiotic use in prior 3 months
• Blood pressure (BP) \> 159/99 mmHg
• Change in type or dose of these prescription medications over the past 6 months: antihypertensive medications, Statins, hormone replacement therapy (estrogen or testosterone) or oral contraceptives, thyroid medications
• 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)

Sponsors & Collaborators

• Virginia Polytechnic Institute and State University: lead

Study Sites (1)

Virginia Tech

Blacksburg, Virginia, 24061, 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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 1, 2026
• Study Start: August 1, 2022
• Primary Completion: March 5, 2025
• Study Completion: May 1, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)