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Completed

NCT Number: NCT02335021

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

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.

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Key information

Age range

23 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University

New Haven, Connecticut, 06510, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sucralose

Dietary Supplement

2 packets per 12 fl oz

Sucrose

Dietary Supplement

equisweet to sucralose

Sucralose + maltodextrin

Dietary Supplement

sucralose plus equicaloric (to sucrose) maltodextrin

Sucralose + Sucrose

Dietary Supplement

half the amount of sucralose plus equicaloric sucrose

Primary outcomes

  1. Ratings of taste sensitivity

    Time frame: up to one week after intervention

    general labeled magnitude scale ratings of taste intensity

Secondary outcomes

  1. Ad libitum food intake

    Time frame: up to one week after intervention

    amount of Mac&Cheese consumed

  2. brain response to taste stimuli

    Time frame: up to one week after intervention

    BOLD response as measured by fMRI

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: AFS-adult

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jan 9, 2015
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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