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

Not Applicable

Completed

• Conditions: Normal Subjects
• Interventions: Other: Ingestion of sugar-sweetened beverages; Other: Ingestion of artificially-sweetened beverages; Other: Ingestion of water

• Registration Number: NCT02973334
• Lead Sponsor: University of Lausanne

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,

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-11-21
• Study First Posted: 2016-11-25
• Primary Completion: 2017-07
• Study Completion: 2017-07
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-28
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sugar	Ingestion of sugar-sweetened beverages	Effects of ingestion of sugar-sweetened beverages on acute stress response
Artificial sweetener	Ingestion of artificially-sweetened beverages	Effects of ingestion of artificially-sweetened beverages on acute stress response
Water	Ingestion of water	Effects of ingestion of water on acute stress response

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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
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.

Trial Locations

Locations (1)

University of Lausanne; 🇨🇭 Lausanne, Switzerland