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

Sponsor
University of Lausanne (Other)
Overall Status
Completed
CT.gov ID
NCT02973334
Collaborator
(none)
12
1
3
21
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Ingestion of artificially-sweetened beverages
  • Other: Ingestion of sugar-sweetened beverages
  • Other: Ingestion of water
N/A

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,

  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Basic Science
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 Start Date :
Oct 1, 2015
Actual Primary Completion Date :
Jul 1, 2017
Actual Study Completion Date :
Jul 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Hemodynamic changes [Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)]

    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

Secondary Outcome Measures

  1. Changes in concentration of blood glucose [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]

    Blood glucose concentration will be measured in fasting conditions and during stress tests with the glucose oxidase method and expressed in mg/dl

  2. Changes in concentration of blood insulin [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]

    Blood insulin concentration will be measured by ELISA and expressed in mU/L

  3. Changes in blood non-esterified fatty acid concentration [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]

    Blood non-esterified fatty acid concentration will be measured by a colorimetric method and expressed in mmol/L

  4. Metabolic changes [Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)]

    Metabolic changes elicited by stress will be continually monitored from respiratory gas exchanges by indirect calorimetry.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Lausanne Lausanne Switzerland 1005

Sponsors and Collaborators

  • University of Lausanne

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:
NCT02973334
Other Study ID Numbers:
  • 316/15
First Posted:
Nov 25, 2016
Last Update Posted:
Dec 29, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Luc Tappy, MD, Full Professor, University of Lausanne

Study Results

No Results Posted as of Dec 29, 2017