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Clinical Trials/NCT02973334
NCT02973334CompletedNot Applicable

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.

University of Lausanne2 sites in 1 country12 target enrollmentStarted: October 2015Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
12
Locations
2
Primary Endpoint
Hemodynamic changes

Study Overview

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,
  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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Arms & Interventions

Sugar

Experimental

Effects of ingestion of sugar-sweetened beverages on acute stress response

Intervention: Ingestion of sugar-sweetened beverages (Other)

Artificial sweetener

Experimental

Effects of ingestion of artificially-sweetened beverages on acute stress response

Intervention: Ingestion of artificially-sweetened beverages (Other)

Water

Active Comparator

Effects of ingestion of water on acute stress response

Intervention: Ingestion of water (Other)

Outcomes

Primary Outcomes

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

  • 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)
  • 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)
  • 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)
  • Metabolic changes(Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Luc Tappy, MD

Full Professor

University of Lausanne

Study Sites (2)

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