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Completed

NCT Number: NCT02973334

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Lausanne

Lausanne, 1005, Switzerland

About this study

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:

  • a 90 minutes baseline period (t=0-90 min),
  • 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.
  • a 30-min MS recovery period (t=120-150),
  • 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,
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ingestion of artificially-sweetened beverages

Other

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

Other

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

Other

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.

Primary outcomes

  1. Hemodynamic changes

    Time frame: 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 outcomes

  1. Changes in concentration of blood glucose

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Lausanne

Other

Registry information

Official study 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.

Acronym: EduStress

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 25, 2016
Registry last updated
Dec 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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