Role of Sweetness in Glucose Regulation

NCT03844230 | Unknown

• 1 other identifier: 19294
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

sweeteners; glucose metabolism; taste receptors; sucralose

Outcome Measures

Primary Outcomes (4)

• Plasma Glucose

  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

  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

  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

  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

Study Arms (2)

Inhibition Group

OTHER

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; Other: Experimental I- Inhibition; Other: Experimental II- Inhibition; Other: Sensory Evaluation

Stimulation Group

OTHER

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; Other: Experimental I- Stimulation; Other: Experimental II- Stimulation; Other: Sensory Evaluation

Interventions

Control - Inhibition OTHER

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

Inhibition Group

Experimental I- Inhibition OTHER

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

Inhibition Group

Experimental II- Inhibition OTHER

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

Inhibition Group

Control- Stimulation OTHER

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

Stimulation Group

Experimental I- Stimulation OTHER

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

Stimulation Group

Experimental II- Stimulation OTHER

Drink sucralose 10 minutes before drinking a glucose load

Stimulation Group

Sensory Evaluation OTHER

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

Inhibition Group; Stimulation Group

Eligibility Criteria

• Age: 21 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

University of Illinois at Urbana Champaign

Champaign, Illinois, 61820, United States

RECRUITING

Related Publications (6)

• Adams TB, Cohen SM, Doull J, Feron VJ, Goodman JI, Marnett LJ, Munro IC, Portoghese PS, Smith RL, Waddell WJ, Wagner BM; Expert Panel of the Flavor and Extract Manufacturers Association. The FEMA GRAS assessment of phenethyl alcohol, aldehyde, acid, and related acetals and esters used as flavor ingredients. Food Chem Toxicol. 2005 Aug;43(8):1179-206. doi: 10.1016/j.fct.2004.11.013. Epub 2005 Jan 26.

  PMID: 15950814 BACKGROUND

• Schiffman SS, Booth BJ, Sattely-Miller EA, Graham BG, Gibes KM. Selective inhibition of sweetness by the sodium salt of +/-2-(4-methoxyphenoxy)propanoic acid. Chem Senses. 1999 Aug;24(4):439-47. doi: 10.1093/chemse/24.4.439.

  PMID: 10480680 BACKGROUND

• Jiang P, Cui M, Zhao B, Liu Z, Snyder LA, Benard LM, Osman R, Margolskee RF, Max M. Lactisole interacts with the transmembrane domains of human T1R3 to inhibit sweet taste. J Biol Chem. 2005 Apr 15;280(15):15238-46. doi: 10.1074/jbc.M414287200. Epub 2005 Jan 24.

  PMID: 15668251 BACKGROUND

• Karimian Azari E, Smith KR, Yi F, Osborne TF, Bizzotto R, Mari A, Pratley RE, Kyriazis GA. Inhibition of sweet chemosensory receptors alters insulin responses during glucose ingestion in healthy adults: a randomized crossover interventional study. Am J Clin Nutr. 2017 Apr;105(4):1001-1009. doi: 10.3945/ajcn.116.146001. Epub 2017 Mar 1.

  PMID: 28251932 BACKGROUND

• Pepino MY, Tiemann CD, Patterson BW, Wice BM, Klein S. Sucralose affects glycemic and hormonal responses to an oral glucose load. Diabetes Care. 2013 Sep;36(9):2530-5. doi: 10.2337/dc12-2221. Epub 2013 Apr 30.

  PMID: 23633524 BACKGROUND

• Steinert RE, Gerspach AC, Gutmann H, Asarian L, Drewe J, Beglinger C. The functional involvement of gut-expressed sweet taste receptors in glucose-stimulated secretion of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Clin Nutr. 2011 Aug;30(4):524-32. doi: 10.1016/j.clnu.2011.01.007. Epub 2011 Feb 15.

  PMID: 21324568 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Contraception

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics

Study Officials

• Marta Y Pepino, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marta Y Pepino, PhD

CONTACT

(217) 300-2374; ypepino@illinois.edu

Clara Salame, MSc, RD

CONTACT

(217) 300-4709; csalame2@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 18, 2019
• Study Start: April 24, 2019
• Primary Completion: November 30, 2022
• Study Completion: December 31, 2022
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, 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.

Locations

US (1)