Clinical trial NCT02853773: Effects of Consuming Artificial Sweeteners and Sugar on Cerebral and Physiological Responses
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Subjects
Keywords: sweeteners
sugar
EEG
food viewing
food intake
Lead sponsor: University of Lausanne
Sponsor class: OTHER
Collaborators: name: University of Lausanne Hospitals
First posted: 2016-08-03
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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).

Eligibility 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

Primary outcomes:
measure: Spatio-temporal brain dynamics
timeFrame: differences observed between 60 min before and 60 min after ingestion of a test meal
Secondary outcomes:
measure: Changes in concentration of blood insulin
timeFrame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
measure: Changes in concentration of blood triglyceride
timeFrame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
measure: Changes in concentration of blood Fibroblast Growth Factor (FGF)-21
timeFrame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
measure: spontaneous food intake
timeFrame: 240 min after ingestion of a test meal
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Department of Physiology
state: Vaud
Study officials:
affiliation: Department of Physiology, University of Lausanne, Switzerland
name: Luc Tappy, Professor
role: PRINCIPAL_INVESTIGATOR
References: