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Effects of Consuming Artificial Sweeteners and Sugar on Cerebral and Physiological Responses (SUGART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02853773
Recruitment Status : Completed
First Posted : August 3, 2016
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
University of Lausanne Hospitals
Information provided by (Responsible Party):
Luc Tappy, MD, University of Lausanne

Brief Summary:
This study aims at investigating the acute influence of artificially sweetened beverages consumption (as compared with sugar-sweetened beverages and water consumption) on brain responses to the viewing of food images, on physiological responses (gut-derived hormones and lipid metabolites) and on the food intake behavior.

Condition or disease Intervention/treatment Phase
Normal Subjects Other: ingestion of a test meal with sweetener Other: ingestion of a test meal with water Not Applicable

Detailed Description:
This study is made on a randomized controlled crossover design including three conditions (water, sugar, artificial sweeteners). Measurements will be performed in fasting and fed conditions. The test-meal will comprise either an artificially or sugar-sweetened beverage or water (control). The spatio-temporal brain dynamics to the viewing of food pictures will be assessed by means of electroencephalography (EEG) recordings and electrical neuroimaging analyses. Venous blood and urine will be collected. Blood pressure, cardiac frequency and bio-impedance measurements will be performed. Food intake behavior will be assessed by means of questionnaires and a free-choice buffet. Each tested condition (water, sugar, artificial sweeteners) will be preceded by a run-in period during which the participants' diet will be controlled (2-day isoenergetic diet).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Acute Effects of Artificial Sweeteners and Sugar on the Brain Dynamics to Food Image Viewing. An Exploratory, Monocentric, Randomized Controlled Trial in Healthy Young Men
Actual Study Start Date : February 2016
Actual Primary Completion Date : September 29, 2017
Actual Study Completion Date : September 29, 2017

Arm Intervention/treatment
Experimental: Artificial sweetener
Effects of co-ingestion of artificially sweetened beverage on the response to a test meal
Other: ingestion of a test meal with sweetener
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks

Active Comparator: Sugar
Effects of co-ingestion of sugar-sweetened beverage on the response to a test meal
Other: ingestion of a test meal with sweetener
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks

Active Comparator: Water
Effects of co-ingestion of water on the response to a test meal
Other: ingestion of a test meal with water
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters




Primary Outcome Measures :
  1. Spatio-temporal brain dynamics [ Time Frame: differences observed between 60 min before and 60 min after ingestion of a test meal ]
    Spatio-temporal brain dynamics to the viewing of food will be assessed by means of electroencephalography recordings.


Secondary Outcome Measures :
  1. Changes in concentration of blood insulin [ Time Frame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal ]
    Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal

  2. Changes in concentration of blood triglyceride [ Time Frame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal ]
    Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal

  3. Changes in concentration of blood Fibroblast Growth Factor (FGF)-21 [ Time Frame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal ]
    Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal

  4. spontaneous food intake [ Time Frame: 240 min after ingestion of a test meal ]
    Food intake behavior will be assessed by monitoring spontaneous food intake when offered a free-choice buffet.



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy
  • Caucasian
  • Right-handed
  • Weak to normal physical activity (< 3hours per week)
  • Normal-weight (19<BMI<25 kg/m2)
  • Regular consumption of sugar-sweetened beverages (>33cl per week)

Exclusion Criteria:

  • Consumption of artificially sweetened beverages exceeding 33cl per week
  • Diabetes
  • Cardiovascular, kidney, hepatic and/or psychological disorders
  • Blood pressure at rest > 140/90mmHg
  • Body weight < 50kg
  • Hemoglobin < 13.5g/dl
  • Ferritin < 50microg/l
  • Drug consumption
  • Alcohol consumption (>10g/day)
  • Smoking
  • Any particular diet (e.g. vegetarianism), food allergy and/or intolerance
  • Body weight gain or loss of >3kg during the last 3 months

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): NCT02853773


Locations
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Switzerland
Department of Physiology
Lausanne, Vaud, Switzerland, 1005
Sponsors and Collaborators
University of Lausanne
University of Lausanne Hospitals
Investigators
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Principal Investigator: Luc Tappy, Professor Department of Physiology, University of Lausanne, Switzerland
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Responsible Party: Luc Tappy, MD, Full professor, University of Lausanne
ClinicalTrials.gov Identifier: NCT02853773    
Other Study ID Numbers: 353/15
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luc Tappy, MD, University of Lausanne:
sweeteners
sugar
EEG
food viewing
food intake