Acute Effects of Artificial Sweeteners or Sugar on Hemodynamic and Metabolic Stress Responses

Normal Subjects Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02973334
• Other study ID #: 316/15
• Status: Completed
• Phase: N/A
• First received: November 14, 2016
• Last updated: December 28, 2017
• Start date: October 2015
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: University of Lausanne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Normal Subjects

Intervention

Other:
• Ingestion of artificially-sweetened beverages
From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing non nutritive sweeteners (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
• Ingestion of sugar-sweetened beverages
From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing sugar (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
• Ingestion of water
From t=60 to the end of the metabolic test, volunteers will ingest 7 water beverages (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.

Locations

Country	Name	City	State
Switzerland	University of Lausanne	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemodynamic changes	Hemodynamic changes elicited by stress will be assessed by means of systemic vascular resistance calculated as (blood flow):(mean arterial pressure, and expressed in arbitrary units	Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
Secondary	Changes in concentration of blood glucose	Blood glucose concentration will be measured in fasting conditions and during stress tests with the glucose oxidase method and expressed in mg/dl	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
Secondary	Changes in concentration of blood insulin	Blood insulin concentration will be measured by ELISA and expressed in mU/L	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
Secondary	Changes in blood non-esterified fatty acid concentration	Blood non-esterified fatty acid concentration will be measured by a colorimetric method and expressed in mmol/L	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
Secondary	Metabolic changes	Metabolic changes elicited by stress will be continually monitored from respiratory gas exchanges by indirect calorimetry.	Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)