AFS-adult: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02335021
• Collaborator: (none)
• Enrollment: 97
• Location: 1
• Arms: 4
• Actual Duration (Months): 51.7
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the effects of dietary exposure to artificial sweeteners on taste sensitivity, preference and brain response in adults. The investigators hypothesize that dietary exposure to artificial sweeteners (sucralose) will decrease sensitivity to taste, shift preference of sweet and savory taste to a higher dose, and reduce brain response in amygdala to sweet taste compared to sucrose.

Condition or Disease	Intervention/Treatment	Phase
Impairment of Oral Perception; Insulin Resistance	Dietary Supplement: Sucralose; Dietary Supplement: Sucrose; Dietary Supplement: Sucralose + maltodextrin; Dietary Supplement: Sucralose + Sucrose	N/A

Detailed Description

We aim to identify neural factors that contribute to taste intensity perception in humans and to determine environmental mechanisms that contribute to variation in taste sensitivity. Significant controversy surrounds the possibility that consumption of artificial sweeteners (AFS) leads to weight gain. Given that the five FDA approved AFSs are found in thousands of foods (Yang 2010) this marks a clear and significant gap in knowledge. Our preliminary data demonstrate a 3-fold decrease in sweet taste sensitivity following consumption of a beverage sweetened with two packets of Splenda for just 10 days. These data provide strong evidence that repeated exposure to sucralose reduces perception of sweet taste intensity, most likely by down-regulation of the sweet taste receptor. Therefore, it is imperative that we gain a greater understanding of the physiological consequences of AFS, since alterations in sweet taste perception, metabolism and brain reward that occur in response to AFS exposure may promote weight gain.

Study Design

• Study Type: Interventional
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: The Effect of Artificial Sweeteners (AFS) on Sweetness Sensitivity, Preference and Brain Response in Adults
• Actual Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Apr 24, 2019
• Actual Study Completion Date: Apr 24, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sucralose Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucralose.	Dietary Supplement: Sucralose; 2 packets per 12 fl oz
Experimental: Sucrose Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with sucrose.	Dietary Supplement: Sucrose; equisweet to sucralose
Experimental: Sucralose + maltodextrin Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + maltodextrin .	Dietary Supplement: Sucralose + maltodextrin; sucralose plus equicaloric (to sucrose) maltodextrin
Experimental: Sucralose + Sucrose Participants will rate sweetness, sourness, saltiness, bitterness and umami intensity of various taste stimuli. Next they will consume a flavored beverage with Splenda + sucrose.	Dietary Supplement: Sucralose + Sucrose; half the amount of sucralose plus equicaloric sucrose

Outcome Measures

Primary Outcome Measures

1. Ratings of taste sensitivity [up to one week after intervention]

   general labeled magnitude scale ratings of taste intensity

Secondary Outcome Measures

1. Ad libitum food intake [up to one week after intervention]

   amount of Mac&Cheese consumed

2. brain response to taste stimuli [up to one week after intervention]

   BOLD response as measured by fMRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 23 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy

• Fluent in English

• Right handed

Exclusion Criteria:

• History of oral nerve damage,

• presence of known taste or smell disorder,

• food allergies or sensitivities (for example nuts, lactose, artificial sweeteners),

• history of CNS disease,

• diabetes,

• history of DSM-IV major psychiatric disorder,

• including alcohol and substance abuse,

• chronic use of medication that may affect taste,

• conditions that may interfere with gustatory or olfactory perception (colds, seasonal allergies,

• recent smoking history),

• aberrant stimulus ratings,

• contra-indication for fMRI,

• uncomfortable swallowing in supine position,

• discomfort or anxiety associated with insertion an intravenous catheter,

• regular artificial sweetener use.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yale University	New Haven	Connecticut	United States	06510

Sponsors and Collaborators

• Yale University

Investigators

• Principal Investigator: Dana M Small, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT02335021
• Other Study ID Numbers: 0405026766-2
• First Posted: Jan 9, 2015
• Last Update Posted: Sep 26, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Insulin Resistance

Study Results

No Results Posted as of Sep 26, 2019