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

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.

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.

Study Overview

• Status: Completed
• Conditions: Normal Subjects
• Intervention / Treatment: Other: Ingestion of sugar-sweetened beverages; Other: Ingestion of artificially-sweetened beverages; Other: Ingestion of water

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1005
    • University of Lausanne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sugar; Effects of ingestion of sugar-sweetened beverages on acute stress response	Other: 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.
Experimental: Artificial sweetener; Effects of ingestion of artificially-sweetened beverages on acute stress response	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.
Active Comparator: Water; Effects of ingestion of water on acute stress response	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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)

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: November 21, 2016
• First Posted (Estimate): November 25, 2016

Study Record Updates

• Last Update Posted (Actual): December 29, 2017
• Last Update Submitted That Met QC Criteria: December 28, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: stress response; sweeteners; sugar
• Other Study ID Numbers: 316/15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO