STS: Role of Sweetness in Glucose Regulation

Sponsor
University of Illinois at Urbana-Champaign (Other)
Overall Status
Recruiting
CT.gov ID
NCT03844230
Collaborator
Washington University School of Medicine (Other)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Control - Inhibition
  • Other: Experimental I- Inhibition
  • Other: Experimental II- Inhibition
  • Other: Control- Stimulation
  • Other: Experimental I- Stimulation
  • Other: Experimental II- Stimulation
  • Other: Sensory Evaluation
N/A

Detailed Description

The overall goal of this research is to assess the role of oral and gut sweetness signaling in postprandial glucose metabolism and to determine how acute and chronic low-calorie sweetener (LCS) consumption may affect this signaling in people with obesity. The aims will determine the independent and combined contributions of pharmacological inhibition (Aim 1) or extra stimulation (Aim 2) of sweet taste signaling in the gut, mouth, or both on hormonal responses to an oral glucose tolerance test (OGTT) in two groups of subjects with obesity: habitual and non-habitual LCS consumers. Validated sensory evaluation techniques will also ascertain subjects' taste perception (Aim 3) to test the hypotheses that habitual consumption of LCS blunts perception of sweetness and, in turn, affects postprandial glucose regulation.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Role of Sweet Taste Signaling in Glucose Regulation
Actual Study Start Date :
Apr 24, 2019
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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: Control - Inhibition
Taste and spit up water 10 minutes before drinking a glucose load

Other: Experimental I- Inhibition
Taste and spit up water 10 minutes before drinking a glucose load mixed with lactisole

Other: Experimental II- Inhibition
Taste and spit up sucralose 10 minutes before drinking a glucose load mixed with lactisole

Other: Sensory Evaluation
Taste different solutions to evaluate sweet taste preference, suprathreshold intensity and detection threshold

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).

Other: Control- Stimulation
Taste and spit up water 10 minutes before drinking a glucose load

Other: Experimental I- Stimulation
Taste and spit up sucralose 10 minutes before drinking a glucose load

Other: Experimental II- Stimulation
Drink sucralose 10 minutes before drinking a glucose load

Other: Sensory Evaluation
Taste different solutions to evaluate sweet taste preference, suprathreshold intensity and detection threshold

Outcome Measures

Primary Outcome Measures

  1. Plasma Glucose [Up to 5 hours after drinking a glucose load]

    Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma glucose concentration

  2. Plasma Insulin [Up to 5 hours after drinking a glucose load]

    Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma insulin concentration

  3. Plasma C-Peptide [Up to 5 hours after drinking a glucose load]

    Blood samples will be collected before and for 5 hours after drinking a glucose load to determine plasma C-peptide concentration

  4. Sensory Evaluation [Up to 2 hours]

    Participants will be tasting solutions containing different concentrations of glucose, sucrose and sucralose (some of the solutions will also have lactisole) to assess their detection threshold, sweet taste intensity and preference. They will have to rate the intensity of the solution on a general Labeled Magnitude Scale (gLMS) ranging from "no sensation" (0) to "strongest imaginable sensation" (100) and choose the solutions they prefer.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 40 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Illinois at Urbana Champaign Champaign Illinois United States 61820

Sponsors and Collaborators

  • University of Illinois at Urbana-Champaign
  • Washington University School of Medicine

Investigators

  • Principal Investigator: Marta Y Pepino, PhD, University of Illinois at Urbana-Champaign

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier:
NCT03844230
Other Study ID Numbers:
  • 19294
First Posted:
Feb 18, 2019
Last Update Posted:
Apr 27, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Illinois at Urbana-Champaign

Study Results

No Results Posted as of Apr 27, 2021