Normal SubjectsSUGARTNCT02853773
Effects of Consuming Artificial Sweeteners and Sugar on Cerebral and Physiological Responses
A study testing ingestion of a test meal with sweetener and ingestion of a test meal with water in people with Normal Subjects, run by University of Lausanne at 1 site in Switzerland.
Trial summary
This study aims at investigating the acute influence of artificially sweetened beverages consumption (as compared with sugar-sweetened beverages and water consumption) on brain responses to the viewing of food images, on physiological responses (gut-derived hormones and lipid metabolites) and on the food intake… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Normal Subjects
- What is being tested?
- ingestion of a test meal with sweetener and ingestion of a test meal with water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2016to 29 Sep 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Caucasian
- Right-handed
- Weak to normal physical activity (< 3hours per week)
- Normal-weight (19<BMI<25 kg/m2)
- Regular consumption of sugar-sweetened beverages (>33cl per week)
Who cannot join
- Consumption of artificially sweetened beverages exceeding 33cl per week
- Diabetes
- Cardiovascular, kidney, hepatic and/or psychological disorders
- Blood pressure at rest > 140/90mmHg
- Body weight < 50kg
- Hemoglobin < 13.5g/dl
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- Ferritin < 50microg/l
- Drug consumption
- Alcohol consumption (>10g/day)
- Smoking
- Any particular diet (e.g. vegetarianism), food allergy and/or intolerance
- Body weight gain or loss of >3kg during the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Artificial Sweeteners and Sugar on the Brain Dynamics to Food Image Viewing. An Exploratory, Monocentric, Randomized Controlled Trial in Healthy Young Men
This study aims at investigating the acute influence of artificially sweetened beverages consumption (as compared with sugar-sweetened beverages and water consumption) on brain responses to the viewing of food images, on physiological responses (gut-derived hormones and lipid metabolites) and on the food intake behavior.
Read the detailed description
This study is made on a randomized controlled crossover design including three conditions (water, sugar, artificial sweeteners). Measurements will be performed in fasting and fed conditions. The test-meal will comprise either an artificially or sugar-sweetened beverage or water (control). The spatio-temporal brain dynamics to the viewing of food pictures will be assessed by means of electroencephalography (EEG) recordings and electrical neuroimaging analyses. Venous blood and urine will be collected. Blood pressure, cardiac frequency and bio-impedance measurements will be performed. Food intake behavior will be assessed by means of questionnaires and a free-choice buffet. Each tested condition (water, sugar, artificial sweeteners) will be preceded by a run-in period during which the participants' diet will be controlled (2-day isoenergetic diet).
- Conditions
- Normal Subjects
- Being tested
- ingestion of a test meal with sweetener, ingestion of a test meal with water
- Keywords
- sweeteners, sugar, EEG, food viewing, food intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ingestion of a test meal with sweetenerOther
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks
ingestion of a test meal with sweetenerOther
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks
ingestion of a test meal with waterOther
participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters
| Study group | Role | What they receive |
|---|---|---|
| Artificial sweetener | Experimental | Effects of co-ingestion of artificially sweetened beverage on the response to a test meal Receives: Other: ingestion of a test meal with sweetener |
| Sugar | Active comparator | Effects of co-ingestion of sugar-sweetened beverage on the response to a test meal Receives: Other: ingestion of a test meal with sweetener |
| Water | Active comparator | Effects of co-ingestion of water on the response to a test meal Receives: Other: ingestion of a test meal with water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spatio-temporal brain dynamics
Spatio-temporal brain dynamics to the viewing of food will be assessed by means of electroencephalography recordings.
Measured: differences observed between 60 min before and 60 min after ingestion of a test meal
Secondary outcomes (4)
Changes in concentration of blood insulin
Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal
Measured: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
Changes in concentration of blood triglyceride
Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal
Measured: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
Changes in concentration of blood Fibroblast Growth Factor (FGF)-21
Blood substrate concentration will be measured in fasting conditions and after ingestion of a test meal
Measured: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
spontaneous food intake
Food intake behavior will be assessed by monitoring spontaneous food intake when offered a free-choice buffet.
Measured: 240 min after ingestion of a test meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startFeb 2016
- Primary completion29 Sep 2017
- Study completion29 Sep 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- 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
- NCT02853773
- Sponsor's protocol ID
- 353/15
- Acronym
- SUGART
- Status last verified
- Jul 2016
- First submitted
- 8 Feb 2016
- Last updated
- 26 Oct 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 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Artificial Sweeteners and Sugar on the Brain Dynamics to Food Image Viewing. An Exploratory, Monocentric, Randomized Controlled Trial in Healthy Young Men
- ClinicalTrials.gov ID
- NCT02853773
- Acronym / sponsor ID
- SUGART / 353/15
- Conditions
- Normal Subjects
- Keywords
- sweeteners, sugar, EEG, food viewing, food intake
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- Feb 2016 (actual)
- Primary completion
- 29 Sep 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 3 Aug 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 study aims at investigating the acute influence of artificially sweetened beverages consumption (as compared with sugar-sweetened beverages and water consumption) on brain responses to the viewing of food images, on physiological responses (gut-derived hormones and lipid metabolites) and on the food intake behavior.
Detailed description
This study is made on a randomized controlled crossover design including three conditions (water, sugar, artificial sweeteners). Measurements will be performed in fasting and fed conditions. The test-meal will comprise either an artificially or sugar-sweetened beverage or water (control). The spatio-temporal brain dynamics to the viewing of food pictures will be assessed by means of electroencephalography (EEG) recordings and electrical neuroimaging analyses. Venous blood and urine will be collected. Blood pressure, cardiac frequency and bio-impedance measurements will be performed. Food intake behavior will be assessed by means of questionnaires and a free-choice buffet. Each tested condition (water, sugar, artificial sweeteners) will be preceded by a run-in period during which the participants' diet will be controlled (2-day isoenergetic diet).
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 |
|---|---|---|
| Artificial sweetener | Experimental | Other: ingestion of a test meal with sweetenerEffects of co-ingestion of artificially sweetened beverage on the response to a test meal |
| Sugar | Active comparator | Other: ingestion of a test meal with sweetenerEffects of co-ingestion of sugar-sweetened beverage on the response to a test meal |
| Water | Active comparator | Other: ingestion of a test meal with waterEffects of co-ingestion of water on the response to a test meal |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Healthy
- Caucasian
- Right-handed
- Weak to normal physical activity (< 3hours per week)
- Normal-weight (19<BMI<25 kg/m2)
Key exclusion criteria (12 listed)
- Consumption of artificially sweetened beverages exceeding 33cl per week
- Diabetes
- Cardiovascular, kidney, hepatic and/or psychological disorders
- Blood pressure at rest > 140/90mmHg
- Body weight < 50kg
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 a test meal with sweetenerparticipants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks | Other | Artificial sweetener |
| ingestion of a test meal with sweetenerparticipants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks | Other | Sugar |
| ingestion of a test meal with waterparticipants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters | Other | Water |
Primary outcome
Spatio-temporal brain dynamics
Time frame: differences observed between 60 min before and 60 min after ingestion of a test meal
Spatio-temporal brain dynamics to the viewing of food will be assessed by means of electroencephalography recordings.
4 secondary outcomes
Changes in concentration of blood insulin
Time frame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
Changes in concentration of blood triglyceride
Time frame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
Changes in concentration of blood Fibroblast Growth Factor (FGF)-21
Time frame: -120 min before ingestion of a test meal, and 30, 60, 90, 150, and 210 min after ingestion of a test meal
spontaneous food intake
Time frame: 240 min after ingestion of a test meal
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 26 Oct 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 a test meal with sweetener and ingestion of a test meal with 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 6 inclusion and 12 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 26 Oct 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?
Spatio-temporal brain dynamics (time frame: differences observed between 60 min before and 60 min after ingestion of a test meal). 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 26 Oct 2017.