Normal SubjectsEduStressNCT02973334
Acute Effects of Artificial Sweeteners or Sugar on Hemodynamic and Metabolic Stress Responses
A study testing Ingestion of artificially-sweetened beverages, Ingestion of sugar-sweetened beverages and Ingestion of water in people with Normal Subjects, run by University of Lausanne at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Subjects
- What is being tested?
- Ingestion of artificially-sweetened beverages, Ingestion of sugar-sweetened beverages and Ingestion of water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2015to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Caucasian
- Normal Body Mass Index (18.5 ≤BMI≤ 25 kg/m2)
- Monophasic oral contraceptive
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the 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:
- 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.
- Conditions
- Normal Subjects
- Being tested
- Ingestion of artificially-sweetened beverages, Ingestion of sugar-sweetened beverages, Ingestion of water
- Keywords
- sweeteners, sugar, stress response
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Sugar | Experimental | Effects of ingestion of sugar-sweetened beverages on acute stress response Receives: Other: Ingestion of sugar-sweetened beverages |
| Artificial sweetener | Experimental | Effects of ingestion of artificially-sweetened beverages on acute stress response Receives: Other: Ingestion of artificially-sweetened beverages |
| Water | Active comparator | Effects of ingestion of water on acute stress response Receives: Other: Ingestion of water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 glucose concentration will be measured in fasting conditions and during stress tests with the glucose oxidase method and expressed in mg/dl
Measured: 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 insulin concentration will be measured by ELISA and expressed in mU/L
Measured: 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 non-esterified fatty acid concentration will be measured by a colorimetric method and expressed in mmol/L
Measured: 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
Metabolic changes elicited by stress will be continually monitored from respiratory gas exchanges by indirect calorimetry.
Measured: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startOct 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc TAPPY, Professor, Principal investigator, Department of Physiology, University of Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973334
- Sponsor's protocol ID
- 316/15
- Acronym
- EduStress
- Status last verified
- Dec 2017
- First submitted
- 14 Nov 2016
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT02973334
- Acronym / sponsor ID
- EduStress / 316/15
- Conditions
- Normal Subjects
- Keywords
- sweeteners, sugar, stress response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 25 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sugar | Experimental | Other: Ingestion of sugar-sweetened beveragesEffects of ingestion of sugar-sweetened beverages on acute stress response |
| Artificial sweetener | Experimental | Other: Ingestion of artificially-sweetened beveragesEffects of ingestion of artificially-sweetened beverages on acute stress response |
| Water | Active comparator | Other: Ingestion of waterEffects of ingestion of water on acute stress response |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Caucasian
- Normal Body Mass Index (18.5 ≤BMI≤ 25 kg/m2)
- Monophasic oral contraceptive
Key exclusion criteria (14 listed)
- Hypertension (Blood pressure >140/90 mmHg)
- History or actual psychologic/cardiovascular troubles
- Anemia anamnesis
- Being Pregnant
- Weight < 50 kg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ingestion of artificially-sweetened beveragesFrom 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. | Other | Artificial sweetener |
| Ingestion of sugar-sweetened beveragesFrom 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. | Other | Sugar |
| Ingestion of waterFrom 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. | Other | Water |
Primary outcome
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
4 secondary outcomes
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
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
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
Metabolic changes
Time frame: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luc TAPPY, Professor principal investigator
Department of Physiology, University of Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ingestion of artificially-sweetened beverages, Ingestion of sugar-sweetened beverages and Ingestion of water in people with Normal Subjects, run by University of Lausanne at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemodynamic changes (time frame: Differences observed between 90-min baseline and stress (30-min mental stress and 3-min cold pressure test)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2017.