Role of Sweetness in Glucose Regulation (STS)

April 26, 2021 updated by: University of Illinois at Urbana-Champaign

Role of Sweet Taste Signaling in Glucose Regulation

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Champaign, Illinois, United States, 61820
        • Recruiting
        • University of Illinois at Urbana Champaign
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma Glucose
Time Frame: 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
Up to 5 hours after drinking a glucose load
Plasma Insulin
Time Frame: 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
Up to 5 hours after drinking a glucose load
Plasma C-Peptide
Time Frame: 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
Up to 5 hours after drinking a glucose load
Sensory Evaluation
Time Frame: 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.
Up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Illinois at Urbana-Champaign

Collaborators

Washington University School of Medicine

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2019

Primary Completion (Anticipated)

November 30, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

January 29, 2019

First Submitted That Met QC Criteria

February 13, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 27, 2021

Last Update Submitted That Met QC Criteria

April 26, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19294

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Consistent with the need to not compromise human subject protections, raw data that identifies participants will not be shared with anyone not included on our IRB approval. De-identified data, from participants who consented to share their de-identified data will be deposit in a data repository (e.g. Figshare).

IPD Sharing Time Frame

We plan to share data no later than 6 months post-publication or 18 months from the award end date per ADA expectations.

IPD Sharing Access Criteria

Data will be available to qualified individuals within the scientific community for research purposes contingent upon IRB approval for secondary data analysis.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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