ObesityREDUCSNCT01394380
Reduction of Sweetened Beverages and Intrahepatic Fat
A study testing artificially sweetened sodas in people with Obesity and Dyslipidemia, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks, subjects will be randomized to either a 12-week intervention arm in which sweetened beverages will be replaced by artificially sweetened… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Obesity, Dyslipidemia, Metabolic Syndrome
- What is being tested?
- artificially sweetened sodas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Apr 2014
- 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
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- gender male or female
- body mass index (BMI) > 27 kg/m2 consumption of > 2 3dl-can regular soda/day
- low to moderate physical activity (< 60 min walking/day; < 3 exercise session/week
Who cannot join
- diabetes mellitus
- liver, kidney or heart disease
- any current drug treatment
- contra-indications to MR examination (pacemaker, foreign bodies,etc)
- pregnancy or planned pregnancy
- active weight gain or weight loss (weight change > 4 kg in the past 12 months)
Show all 9Show fewer
- consumption of drugs or illicit substances
- consumption of more than 10g alcohol/day
- vegetarians or subjects on special diets
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinical Research Center, CHUV
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: Effects of a Reduction of Sweetened Beverages Consumption in Overweight High Consumers on Cardiometabolic Risk Factors
The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks, subjects will be randomized to either a 12-week intervention arm in which sweetened beverages will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The following measurements will be performed at the end of the run-in period and at the end of the intervention period
- intrahepatic fat concentration
- visceral fat volume
- changes in day-long metabolic profile from baseline(plasma glucose, insulin, and triglyceride concentrations)
- changes in food intake and daily energy, carbohydrate and sugars intake from baseline
- Conditions
- Obesity, Dyslipidemia, Metabolic Syndrome
- Being tested
- artificially sweetened sodas
- Keywords
- sugar, sweetened beverages, hepatic steatosis, visceral obesity, metabolic syndrome
- Medical subject headings
- Obesity, Dyslipidemias, Metabolic Syndrome, Fatty Liver, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificially sweetened sodasOther
subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee
| Study group | Role | What they receive |
|---|---|---|
| artificially sweetened beverages | Experimental | subjects will be required to consume only artificially-sweetened sodas, water, tea or coffee Receives: Other: artificially sweetened sodas |
| regular sodas | No intervention | subjects will continue their usual consumption of sweetened sodas |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in intrahepatic fat concentration
intrahepatic fat content measured by 1H-MRS
Measured: at the end of run-in and after 12 weeks intervention/control
Secondary outcomes (3)
changes in visceral fat volume
Visceral fat volume measured by MRI
Measured: at the end of run-in and after 12 weeks of intervention/control
changes in day-long metabolic profile
Plasma glucose, insulin, non-esterified fatty acids, and triglycerides will be measured at 2-hourly intervals between 7:00 am and 5:00 pm. Participants will be fed standardized meals and either sweetened or artificially-sweetened beverages according to randomization
Measured: at the end of run-in and after 12 weeks of intervention/control
changes in food intake from baseline
Total energy intake, total carbohydrate intake, and total sugars intake will be evaluated by 3-day food record
Measured: at the end of the run-in period and after 6, and 12 weeks of intervention/control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 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, MD, Principal investigator, Department of Physiology, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394380
- Sponsor's protocol ID
- 171/11
- Acronym
- REDUCS
- Status last verified
- Jun 2014
- First submitted
- 12 Jul 2011
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Reduction of Sweetened Beverages Consumption in Overweight High Consumers on Cardiometabolic Risk Factors
- ClinicalTrials.gov ID
- NCT01394380
- Acronym / sponsor ID
- REDUCS / 171/11
- Conditions
- Obesity, Dyslipidemia, Metabolic Syndrome
- Keywords
- sugar, sweetened beverages, hepatic steatosis, visceral obesity, metabolic syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois, Insel Gruppe AG, University Hospital Bern
- Study start
- Oct 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 14 Jul 2011 (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.
The study will enroll 68 overweight male and female subjects with a high (> 2 3dl-can soda/day) consumption of sweetened beverage per day. After a run-in period of 4 weeks, subjects will be randomized to either a 12-week intervention arm in which sweetened beverages will be replaced by artificially sweetened, calorie-free beverages, or to a control arm. The following measurements will be performed at the end of the run-in period and at the end of the intervention period
- intrahepatic fat concentration
- visceral fat volume
- changes in day-long metabolic profile from baseline(plasma glucose, insulin, and triglyceride concentrations)
- changes in food intake and daily energy, carbohydrate and sugars intake from baseline
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| artificially sweetened beverages | Experimental | Other: artificially sweetened sodassubjects will be required to consume only artificially-sweetened sodas, water, tea or coffee |
| regular sodas | No intervention | –subjects will continue their usual consumption of sweetened sodas |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- gender male or female
- body mass index (BMI) > 27 kg/m2 consumption of > 2 3dl-can regular soda/day
- low to moderate physical activity (< 60 min walking/day; < 3 exercise session/week
Key exclusion criteria (9 listed)
- diabetes mellitus
- liver, kidney or heart disease
- any current drug treatment
- contra-indications to MR examination (pacemaker, foreign bodies,etc)
- pregnancy or planned pregnancy
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 |
|---|---|---|
| artificially sweetened sodassubjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee | Other | artificially sweetened beverages |
Primary outcome
changes in intrahepatic fat concentration
Time frame: at the end of run-in and after 12 weeks intervention/control
intrahepatic fat content measured by 1H-MRS
3 secondary outcomes
changes in visceral fat volume
Time frame: at the end of run-in and after 12 weeks of intervention/control
changes in day-long metabolic profile
Time frame: at the end of run-in and after 12 weeks of intervention/control
changes in food intake from baseline
Time frame: at the end of the run-in period and after 6, and 12 weeks of intervention/control
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 4 Jun 2014.
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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, MD principal investigator
Department of Physiology, University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing artificially sweetened sodas in people with Obesity and Dyslipidemia, 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 3 inclusion and 9 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 4 Jun 2014. 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?
changes in intrahepatic fat concentration (time frame: at the end of run-in and after 12 weeks intervention/control). 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 4 Jun 2014.