NCT02973334

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 25, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 29, 2017

Status Verified

December 1, 2017

Enrollment Period

1.8 years

First QC Date

November 14, 2016

Last Update Submit

December 28, 2017

Conditions

Normal Subjects

Keywords

sweetenerssugarstress response

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic changes

    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

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

Secondary Outcomes (4)

  • 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)

Study Arms (3)

Sugar

EXPERIMENTAL

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

Other: Ingestion of sugar-sweetened beverages

Artificial sweetener

EXPERIMENTAL

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

Other: Ingestion of artificially-sweetened beverages

Water

ACTIVE COMPARATOR

Effects of ingestion of water on acute stress response

Other: Ingestion of water

Interventions

Ingestion of artificially-sweetened beveragesOTHER

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.

Artificial sweetener
Ingestion of sugar-sweetened beveragesOTHER

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.

Sugar
Ingestion of waterOTHER

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.

Water

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Caucasian
  • Normal Body Mass Index (18.5 ≤BMI≤ 25 kg/m2)
  • Monophasic oral contraceptive

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Lausanne

Lausanne, 1005, Switzerland

Location

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and Injuries

Study Officials

  • Luc TAPPY, Professor

    Department of Physiology, University of Lausanne, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

November 14, 2016

First Posted

November 25, 2016

Study Start

October 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

December 29, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)