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Trial record 41 of 532 for:    Taste Disorders AND taste

Role of Sweetness in Glucose Regulation (STS)

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ClinicalTrials.gov Identifier: NCT03844230
Recruitment Status : Recruiting
First Posted : February 18, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborator:
Washington University School of Medicine
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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
Obesity 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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 24, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.



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Ages Eligible for Study:   21 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03844230


Contacts
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Contact: Marta Y Pepino, PhD (217) 300-2374 ypepino@illinois.edu
Contact: Clara Salame, MSc, RD (217) 300-4709 csalame2@illinois.edu

Locations
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United States, Illinois
University of Illinois at Urbana Champaign Recruiting
Champaign, Illinois, United States, 61820
Contact: Marta Y Pepino, MSc, RD    217-300-2374    ypepino@illinois.edu   
Contact: Clara Salame, MSc, RD    2178192820    csalame2@illinois.edu   
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Washington University School of Medicine
Investigators
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Principal Investigator: Marta Y Pepino, PhD University of Illinois at Urbana-Champaign

Publications:

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03844230     History of Changes
Other Study ID Numbers: 19294
First Posted: February 18, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
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.
Access Criteria: Data will be available to qualified individuals within the scientific community for research purposes contingent upon IRB approval for secondary data analysis.

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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:
sweeteners
glucose metabolism
taste receptors
sucralose