Effects of Consuming Artificial Sweeteners and Sugar on Cerebral and Physiological Responses

Study Overview
=================
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).

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

Conditions
-----------------
Normal Subjects

Intervention / Treatment
-----------------
* Other: ingestion of a test meal with sweetener
* Other: ingestion of a test meal with sweetener
* Other: ingestion of a test meal with water


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial sweetener<br>Effects of co-ingestion of artificially sweetened beverage on the response to a test meal | Other: ingestion of a test meal with sweetener<br>* participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks<br>|
| Active Comparator: Sugar<br>Effects of co-ingestion of sugar-sweetened beverage on the response to a test meal | Other: ingestion of a test meal with sweetener<br>* participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks<br>|
| Active Comparator: Water<br>Effects of co-ingestion of water on the response to a test meal | Other: ingestion of a test meal with water<br>* participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatio-temporal brain dynamics | Spatio-temporal brain dynamics to the viewing of food will be assessed by means of electroencephalography recordings. | differences observed between 60 min before and 60 min after ingestion of a test meal | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in concentration of blood insulin | Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal | -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal | 
| Changes in concentration of blood triglyceride | Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal | -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal | 
| Changes in concentration of blood Fibroblast Growth Factor (FGF)-21 | Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal | -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal | 
| spontaneous food intake | Food intake behavior will be assessed by monitoring spontaneous food intake when offered a free-choice buffet. | 240 min after ingestion of a test meal | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sweeteners, sugar, EEG, food viewing, food intake