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

Sponsor

University of Lausanne (Other)

Overall Status

Completed

CT.gov ID

NCT02853773

Collaborator

University of Lausanne Hospitals (Other)

Enrollment

Location

Arms

19.9

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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 sweetener Other: ingestion of a test meal with water	N/A

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).

Study Design

Study Type:

Interventional

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 :

Feb 1, 2016

Actual Primary Completion Date :

Sep 29, 2017

Actual Study Completion Date :

Sep 29, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Spatio-temporal brain dynamics [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

Changes in concentration of blood insulin [-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
Changes in concentration of blood triglyceride [-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
Changes in concentration of blood Fibroblast Growth Factor (FGF)-21 [-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
spontaneous food intake [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Physiology	Lausanne	Vaud	Switzerland	1005

Sponsors and Collaborators

University of Lausanne
University of Lausanne Hospitals

Investigators

Principal Investigator: Luc Tappy, Professor, Department of Physiology, University of Lausanne, Switzerland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luc Tappy, MD, Full professor, University of Lausanne

ClinicalTrials.gov Identifier:

NCT02853773

Other Study ID Numbers:

353/15

First Posted:

Aug 3, 2016

Last Update Posted:

Oct 26, 2017

Last Verified:

Jul 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Luc Tappy, MD, Full professor, University of Lausanne

Study Results

No Results Posted as of Oct 26, 2017