ObesityNCT00776971
Effect of Carbonated Soft Drinks on Appetite-Regulation
A study testing Sugar-sweetened soft drink, Aspartame-sweetened soft drink and Semi-skimmed milk in people with Obesity and Diet, run by Aarhus University Hospital at 1 site in Denmark.
Trial summary
Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Sugar-sweetened soft drink, Aspartame-sweetened soft drink and Semi-skimmed milk
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2007to Sep 2008
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-50 years;
- BMI between 28-36 kg/m2;
- Weight stabile 3 months prior to the study inclusion;
- Less than 10 hours of weekly exercise.
Who cannot join
- Diabetes
- Allergic to phenylalanine or milk
- Smoking
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake.
Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.
The investigators aim is to investigate the short-term effects of soft drinks (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety (measured by visual analogue scales) and energy intake. The study is a crossover, intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink, aspartame-sweetened soft drink, semi-skimmed milk or water) is served.
The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.
- Being tested
- Sugar-sweetened soft drink, Aspartame-sweetened soft drink, Semi-skimmed milk, Water
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sugar-sweetened soft drinkOther
500mL as a preload drink
Aspartame-sweetened soft drinkOther
500mL as a preload drink
Semi-skimmed milkOther
500mL as a preload drink
WaterOther
500mL as a preload drink
| Study group | Role | What they receive |
|---|---|---|
| Sugar-sweetened soft drink | Experimental | 54g sugar/L, 180kJ/100mL Receives: Other: Sugar-sweetened soft drink |
| Aspartame-sweetened soft drink | Experimental | 1.5kJ/100mL Receives: Other: Aspartame-sweetened soft drink |
| Semi-skimmed milk | Active comparator | 202kJ/100mL Receives: Other: Semi-skimmed milk |
| Water | Placebo comparator | 0kJ/100mL Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Measured: Four hours
Secondary outcomes (1)
Appetite-regulating hormones, Glucose, Insulin; Energy intake
Measured: Four hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2008 (estimated)
- Study startNov 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Aarhus University HospitalThe sponsor's other registered studies.
- 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- LG Life Sciences
- Investigators
- Bjørn Richelsen, Professor, Study chair, Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00776971
- Sponsor's protocol ID
- 20070134A
- Status last verified
- Aug 2008
- First submitted
- 21 Oct 2008
- Last updated
- 22 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Maersk M, Belza A, Holst JJ, Fenger-Gron M, Pedersen SB, Astrup A, Richelsen B. Satiety scores and satiety hormone response after sucrose-sweetened soft drink compared with isocaloric semi-skimmed milk and with non-caloric soft drink: a controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):523-9. doi: 10.1038/ejcn.2011.223. Epub 2012 Jan 18.
PubMed 22252107
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbonated Soft Drinks May Alter Appetite Sensation and Appetite-Regulating Hormone Level and Lead to Increased Energy Intake.
- ClinicalTrials.gov ID
- NCT00776971
- Acronym / sponsor ID
- 20070134A
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Aarhus University HospitalUniversity, hospital or other
- Collaborators
- LG Life Sciences
- Study start
- Nov 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 22 Oct 2008 (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.
Compared to solid foods, the nutritional energy of drinks may bypass the appetite regulation leading to obesity development. Although drinks sweetened with aspartame are available the anticipated positive effect of these drinks on obesity development has not been convincing. However, the mechanisms linking drinks intake to obesity are yet to be clarified.
The investigators aim is to investigate the short-term effects of soft drinks (sugar-sweetened and artificially sweetened (aspartame)), milk and water on the concentration of circulating appetite-regulating hormones, the subjective sensations of hunger and satiety (measured by visual analogue scales) and energy intake. The study is a crossover, intervention trial with 24 overweight, healthy volunteers. The subjects will be tested on four separate days for four hours. Each test day a preload drink (sugar-sweetened soft drink, aspartame-sweetened soft drink, semi-skimmed milk or water) is served.
The investigators expect to clarify the mechanisms linking drinking habits to obesity development and provide scientifically based nutritional guidelines.
Study design
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sugar-sweetened soft drink | Experimental | Other: Sugar-sweetened soft drink54g sugar/L, 180kJ/100mL |
| Aspartame-sweetened soft drink | Experimental | Other: Aspartame-sweetened soft drink1.5kJ/100mL |
| Semi-skimmed milk | Active comparator | Other: Semi-skimmed milk202kJ/100mL |
| Water | Placebo comparator | Other: Water0kJ/100mL |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 20-50 years;
- BMI between 28-36 kg/m2;
- Weight stabile 3 months prior to the study inclusion;
- Less than 10 hours of weekly exercise.
Key exclusion criteria (4 listed)
- Diabetes
- Allergic to phenylalanine or milk
- Smoking
- Pregnancy or breast-feeding
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 |
|---|---|---|
| Sugar-sweetened soft drink500mL as a preload drink | Other | Sugar-sweetened soft drink |
| Aspartame-sweetened soft drink500mL as a preload drink | Other | Aspartame-sweetened soft drink |
| Semi-skimmed milk500mL as a preload drink | Other | Semi-skimmed milk |
| Water500mL as a preload drink | Other | Water |
Primary outcome
Visual Analogue Scale
Time frame: Four hours
1 secondary outcome
Appetite-regulating hormones, Glucose, Insulin; Energy intake
Time frame: Four hours
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 22 Oct 2008.
- Derived from this study: PubMed 22252107Maersk M, Belza A, Holst JJ, Fenger-Gron M, Pedersen SB, Astrup A, Richelsen B. Satiety scores and satiety hormone response after sucrose-sweetened soft drink compared with isocaloric semi-skimmed milk and with non-caloric soft drink: a controlled trial. Eur J Clin Nutr. 2012 Apr;66(4):523-9. doi: 10.1038/ejcn.2011.223. Epub 2012 Jan 18.
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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.
Bjørn Richelsen, Professor study chair
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sugar-sweetened soft drink, Aspartame-sweetened soft drink and Semi-skimmed milk in people with Obesity and Diet, run by Aarhus University Hospital at 1 site in Denmark.
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 4 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 22 Oct 2008. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
Visual Analogue Scale (time frame: Four hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00776971, which also lists 1 linked publication.
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 22 Oct 2008.