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

NCT ID: NCT02973334

Last Updated: 2017-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Normal Subjects

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

sweeteners sugar stress response

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sugar

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

Group Type EXPERIMENTAL

Ingestion of sugar-sweetened beverages

Intervention Type 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.

Artificial sweetener

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

Group Type EXPERIMENTAL

Ingestion of artificially-sweetened beverages

Intervention Type 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.

Water

Effects of ingestion of water on acute stress response

Group Type ACTIVE_COMPARATOR

Ingestion of water

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Lausanne

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Luc Tappy, MD

Full Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Luc TAPPY, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Physiology, University of Lausanne, Switzerland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Lausanne

Lausanne, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

316/15

Identifier Type: -

Identifier Source: org_study_id