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ObesityNCT00777647

Effect of Carbonated Soft Drinks on the Body Weight

A study testing Sugar-sweetened soft drink, Aspartame-sweetened soft drink and Semi-skimmed milk in people with Obesity and Metabolic; Complications, run by Aarhus University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Conditions the study is for
Obesity, Metabolic; Complications, Dietary Habits
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
60 participants
Where
1 siteDenmark
Study dates
May 2008to Dec 2010
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

Other trials in Denmark

About this study

Official title: Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors

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 long-term effects of intake of soft drinks, milk and water. The study is a parallel, intervention trial with 80 overweight, healthy volunteers. They will be randomly selected to drink one liter a day of one of the four drinks for six months. The objectives are changes in numerous circulating metabolic risk factors, changes in body weight, anthropometric data and fat distribution (measured by DEXA, MRI and MR-spectroscopy).

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, Feeding Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sugar-sweetened soft drinkOther

    One litre a day for six months.

  • Aspartame-sweetened soft drinkOther

    One litre a day for six months.

  • Semi-skimmed milkOther

    One litre a day for six months

  • WaterOther

    One litre a day for six months.

Study groups in NCT00777647
Study groupRoleWhat they receive
Sugar-sweetened soft drinkExperimental54g sugar/L, 180kJ/100mL
Receives: Other: Sugar-sweetened soft drink
Aspartame-sweetened soft drinkExperimental1.5kJ/100mL
Receives: Other: Aspartame-sweetened soft drink
Semi-skimmed milkActive comparator202kJ/100mL
Receives: Other: Semi-skimmed milk
WaterPlacebo comparator0kJ/100mL
Receives: Other: Water

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Body Weight (kg)

    Measured: Six months

  2. MR spectroscopy

    to assess liver fat and skeletal muscle fat

    Measured: Six months

  3. Magnetic resonance imaging

    to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)

    Measured: Six months

  4. Dual-energy X-ray absorptiometry (DEXA) scan

    to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)

    Measured: Six months

Secondary outcomes (8)

  1. Blood pressure

    Systolic and diastolic blood pressure (mmHg)

    Measured: Six months

  2. Circulating metabolic parameters: including serum urate

    mmol/L

    Measured: Six months

  3. fasting plasma glucose

    mmol/L

    Measured: Six months

  4. fasting serum insulin

    pmol/L

    Measured: Six months

  5. Oral Glucose Tolerance Test (OGTT)

    AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index

    Measured: Six months

  6. Fasting blood lipids

    Total, LDL, and HDL cholesterol, and TAG (mmol/L)

    Measured: Six months

  7. Fasting plasma FFA

    mmol/L

    Measured: Six months

  8. Fasting plasma PAI-1

    ng/ml

    Measured: Six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Oct 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2010
  4. Study completionDec 2010

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00777647
Sponsor's protocol ID
20070134B
Status last verified
Mar 2017
First submitted
21 Oct 2008
Last updated
29 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Bajahzer MF, Bruun JM, Rosqvist F, Marklund M, Richelsen B, Riserus U. Effects of sugar-sweetened soda on plasma saturated and monounsaturated fatty acids in individuals with obesity: A randomized study. Front Nutr. 2022 Aug 31;9:936828. doi: 10.3389/fnut.2022.936828. eCollection 2022.

    PubMed 36118751

  • Bruun JM, Maersk M, Belza A, Astrup A, Richelsen B. Consumption of sucrose-sweetened soft drinks increases plasma levels of uric acid in overweight and obese subjects: a 6-month randomised controlled trial. Eur J Clin Nutr. 2015 Aug;69(8):949-53. doi: 10.1038/ejcn.2015.95. Epub 2015 Jun 17.

    PubMed 26081486

  • Maersk M, Belza A, Stodkilde-Jorgensen H, Ringgaard S, Chabanova E, Thomsen H, Pedersen SB, Astrup A, Richelsen B. Sucrose-sweetened beverages increase fat storage in the liver, muscle, and visceral fat depot: a 6-mo randomized intervention study. Am J Clin Nutr. 2012 Feb;95(2):283-9. doi: 10.3945/ajcn.111.022533. Epub 2011 Dec 28.

    PubMed 22205311

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 Metabolic; Complications, 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 29 Mar 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 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?

Body Weight (kg) (time frame: Six months). The study lists 4 primary outcomes in all. 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 NCT00777647, which also lists 3 linked publications.

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 Mar 2017.

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