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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02853773
Other study ID # 353/15
Secondary ID
Status Completed
Phase N/A
First received February 8, 2016
Last updated October 24, 2017
Start date February 2016
Est. completion date September 29, 2017

Study information

Verified date July 2016
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 29, 2017
Est. primary completion date September 29, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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
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
ingestion of a test meal with water
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters

Locations

Country Name City State
Switzerland Department of Physiology Lausanne Vaud

Sponsors (2)

Lead Sponsor Collaborator
University of Lausanne University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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