Clinical trial NCT02973334: Acute Effects of Artificial Sweeteners or Sugar on Hemodynamic and Metabolic Stress Responses
Official title: Acute Effects of Artificial Sweeteners' or Sugar's Ingestion on Hemodynamic and Metabolic Stress Response: An Exploratory, Randomized, Cross-over Trial in Healthy Young Women.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Subjects
Keywords: sweeteners
sugar
stress response
Lead sponsor: University of Lausanne
Sponsor class: OTHER
First posted: 2016-11-25
Enrollment: 12
Sex: FEMALE
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 exploratory study aims at investigating the acute effects of artificially sweetened and sugar beverage consumption (as compared to water consumption) on acute hemodynamic and metabolic stress response.

Detailed description: This single-center study included five visits. The first two visits (screening and familiarization) allowed checking the eligibility of the volunteers. In case of inclusion, the subjects were assigned to a sequence of three experimental conditions (water, sugar and artificial sweeteners), in a randomized, crossover design.

The experimental test was divided into 5 stages:

1. a 90 minutes baseline period (t=0-90 min),
2. a 30-min mental stress (MS; t=90-120 min), consisting in 5-min periods of Stroop's color word conflict test alternated with 5-min periods of mental arithmetic test.
3. a 30-min MS recovery period (t=120-150),
4. a 3-min cold pressure test (CPT) was carried out, aiming at immersing one volunteer's forearm in an ice water container at 3°C,

3) a 15-min CPT recovery period (t=120-150). 60 min after the beginning of the metabolic test, volunteers will drink 25 mL every 15 min, after 10-sec mouth rinsing, of either an artificially- or sugar-sweetened beverages or water (control).

Hemodynamic stress responses will be measured by repeated blood pressure, heart rate and cardiac output. Repeated venous blood samples will allow to assess metabolic stress responses.

Each condition (water, artificial sweeteners and sugar) will be preceded by a 2-day run-in period.

Eligibility criteria: Inclusion Criteria:

* Healthy
* Caucasian
* Normal Body Mass Index (18.5 ≤BMI≤ 25 kg/m2)
* Monophasic oral contraceptive

Exclusion Criteria:

* Hypertension (Blood pressure \>140/90 mmHg)
* History or actual psychologic/cardiovascular troubles
* Anemia anamnesis
* Being Pregnant
* Weight \< 50 kg
* Blood donation or participation to another study \< 8 weeks
* Claustrophobia
* Consumption of sugar/artifically-sweetened beverages drinks \> 5 dL/d
* Visual disturbances (daltonism)
* Low to moderate physical activity (\> 4h/wk)
* Smoker and narcotic consumption
* Caffeine (\> 400 mg/d) and/or alcohol (\> 10g/d) consumption
* Medical treatment
* Weight variation \> 3kg during the last month

Primary outcomes:
measure: Hemodynamic changes
timeFrame: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
Secondary outcomes:
measure: Changes in concentration of blood glucose
timeFrame: Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test
measure: Changes in concentration of blood insulin
timeFrame: Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the test
measure: Changes in blood non-esterified fatty acid concentration
timeFrame: Blood samples will be collected 30, 60, 75, 85, 95, 100, 110, 120, 125, 135, 145, 153, 158, and 163 minutes after the beginning of the tes
measure: Metabolic changes
timeFrame: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: University of Lausanne
Study officials:
affiliation: Department of Physiology, University of Lausanne, Switzerland
name: Luc TAPPY, Professor
role: PRINCIPAL_INVESTIGATOR
References: