Recruiting

Observational Study

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03844230

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

Interventions

Control - Inhibition

Experimental I- Inhibition

Experimental II- Inhibition

Control- Stimulation

Experimental I- Stimulation

Study Details

Brief summary:

Data from several studies show that consuming a diet high in low-calorie sweeteners (LCS), mainly in diet sodas, is linked to the same metabolic disorders as consuming a diet high in added sugars, including an increased risk of developing type 2 diabetes. Sweet taste receptors, once thought to be unique to the mouth, have now been discovered in other parts of the body, including the intestine and the pancreas, where they play a role in blood sugar control. These newly identified receptors provide new avenues to explore how LCS may affect metabolism and health. This project is designed to examine the role of sweet taste signaling, both in the mouth and in the gut, on blood sugar control and how habitual consumption of LCS may affect sweet taste signaling and metabolism in people with obesity.

Conditions

Obesity

Study ID

NCT03844230

Start date

Apr 24, 2019

Status verified date

Apr, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Nov 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 40

Healthy Volunteers: Accepted

Inclusion Criteria:

  • All races/ethnicities
  • Habitual (> 5 diet sodas per week) and non-habitual (≤1 diet soda or 1 packet of LCS per week) LCS consumers
  • 30 ≤ BMI <40 kg/m2
  • Not severely insulin resistant (HOMA-IR2 < 2.6)

Exclusion Criteria:

  • BMI < 30 and 40< BMI kg/m2
  • HOMA-IR2>2.6
  • Irregular LCS consumers (>1 diet sodas or packets of LCS per week but <5)
  • Current smokers or quit smoking nicotine cigarettes for less than 6 months ago
  • Pregnant, breastfeeding, menopausal
  • Presence of anemia : <12g/dl for women and <13g/dl for men
  • Blood donation in the past 8 weeks
  • Presence of malabsorption syndrome
  • History of bariatric surgery
  • Presence of inflammatory intestinal disease, liver or kidney disease
  • Have diabetes (fasting glucose level >126mg/dl or plasma glucose level 2h after glucose challenge >200 mg/dl)
  • Taking any medication that might affect glucose metabolism or the results of our study

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

other: Inhibition Group

Randomly selected habitual and non habitual LCS consumers will be assessed on three different oral glucose tolerance test conditions (i.e. Control - Inhibition, Experimental I- Inhibition, Experimental II- Inhibition). A separate visit will evaluate their sweet taste perception and preferences (Sensory evaluation).

other: Stimulation Group

Randomly selected habitual and non habitual LCS consumers will be assessed on three different oral glucose tolerance test conditions (i.e. Control - Stimulation, Experimental I- Stimulation, Experimental II -Stimulation). A separate visit will evaluate their sweet taste perception and preferences (Sensory evaluation).

Interventions

Control - Inhibition

Taste and spit up water 10 minutes before drinking a glucose load

Experimental I- Inhibition

Taste and spit up water 10 minutes before drinking a glucose load mixed with lactisole

Experimental II- Inhibition

Taste and spit up sucralose 10 minutes before drinking a glucose load mixed with lactisole

Control- Stimulation

Taste and spit up water 10 minutes before drinking a glucose load

Experimental I- Stimulation

Taste and spit up sucralose 10 minutes before drinking a glucose load

Experimental II- Stimulation

Drink sucralose 10 minutes before drinking a glucose load

Sensory Evaluation

Taste different solutions to evaluate sweet taste preference, suprathreshold intensity and detection threshold

Primary outcome measure

  • Plasma Glucose [ Time Frame: Up to 5 hours after drinking a glucose load ]
  • Plasma Insulin [ Time Frame: Up to 5 hours after drinking a glucose load ]
  • Plasma C-Peptide [ Time Frame: Up to 5 hours after drinking a glucose load ]
  • Sensory Evaluation [ Time Frame: Up to 2 hours ]

Central Contacts and Locations

Central contacts

Marta Y Pepino, PhD

(217) 300-2374ypepino@illinois.edu

Clara Salame, MSc, RD

(217) 300-4709csalame2@illinois.edu

Locations

University of Illinois at Urbana Champaign

Recruiting

Champaign, Illinois, United States, 61820

Contacts

Marta Y Pepino, MSc, RD

217-300-2374ypepino@illinois.edu

Clara Salame, MSc, RD

2178192820csalame2@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Apr 27, 2021

Last verified

Apr, 2021

Keywords

  • sweeteners
  • glucose metabolism
  • taste receptors
  • sucralose

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2021-04-27.