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Effect of Carbonated Soft Drinks on the Body Weight

Primary Purpose

Obesity, Metabolic; Complications, Dietary Habits

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Sugar-sweetened soft drink
Aspartame-sweetened soft drink
Semi-skimmed milk
Water
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diabetes
  • Allergic to phenylalanine or milk
  • Smoking
  • Pregnancy or breast-feeding

Sites / Locations

  • Department of Internal Medicine/Endocrinology C, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Sugar-sweetened soft drink

Aspartame-sweetened soft drink

Semi-skimmed milk

Water

Arm Description

54g sugar/L, 180kJ/100mL

1.5kJ/100mL

202kJ/100mL

0kJ/100mL

Outcomes

Primary Outcome Measures

Body Weight (kg)
MR spectroscopy
to assess liver fat and skeletal muscle fat
Magnetic resonance imaging
to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)
Dual-energy X-ray absorptiometry (DEXA) scan
to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)

Secondary Outcome Measures

Blood pressure
Systolic and diastolic blood pressure (mmHg)
Circulating metabolic parameters: including serum urate
mmol/L
fasting plasma glucose
mmol/L
fasting serum insulin
pmol/L
Oral Glucose Tolerance Test (OGTT)
AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index
Fasting blood lipids
Total, LDL, and HDL cholesterol, and TAG (mmol/L)
Fasting plasma FFA
mmol/L
Fasting plasma PAI-1
ng/ml

Full Information

First Posted
October 21, 2008
Last Updated
March 28, 2017
Sponsor
Aarhus University Hospital
Collaborators
LG Life Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00777647
Brief Title
Effect of Carbonated Soft Drinks on the Body Weight
Official Title
Effect of Carbonated Soft Drinks on Body Weight, Fat Distribution and Metabolic Risk Factors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
May 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aarhus University Hospital
Collaborators
LG Life Sciences

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Metabolic; Complications, Dietary Habits

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sugar-sweetened soft drink
Arm Type
Experimental
Arm Description
54g sugar/L, 180kJ/100mL
Arm Title
Aspartame-sweetened soft drink
Arm Type
Experimental
Arm Description
1.5kJ/100mL
Arm Title
Semi-skimmed milk
Arm Type
Active Comparator
Arm Description
202kJ/100mL
Arm Title
Water
Arm Type
Placebo Comparator
Arm Description
0kJ/100mL
Intervention Type
Other
Intervention Name(s)
Sugar-sweetened soft drink
Intervention Description
One litre a day for six months.
Intervention Type
Other
Intervention Name(s)
Aspartame-sweetened soft drink
Intervention Description
One litre a day for six months.
Intervention Type
Other
Intervention Name(s)
Semi-skimmed milk
Intervention Description
One litre a day for six months
Intervention Type
Other
Intervention Name(s)
Water
Intervention Description
One litre a day for six months.
Primary Outcome Measure Information:
Title
Body Weight (kg)
Time Frame
Six months
Title
MR spectroscopy
Description
to assess liver fat and skeletal muscle fat
Time Frame
Six months
Title
Magnetic resonance imaging
Description
to assess visceral adipose tissue (VAT) and subcutaneous abdominal adipose tissue (SAAT)
Time Frame
Six months
Title
Dual-energy X-ray absorptiometry (DEXA) scan
Description
to assess total fat mass (kg), lean body mass (kg), and bone mass (kg)
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic blood pressure (mmHg)
Time Frame
Six months
Title
Circulating metabolic parameters: including serum urate
Description
mmol/L
Time Frame
Six months
Title
fasting plasma glucose
Description
mmol/L
Time Frame
Six months
Title
fasting serum insulin
Description
pmol/L
Time Frame
Six months
Title
Oral Glucose Tolerance Test (OGTT)
Description
AUC OGTT glucose and insulin, AUC HOMA-IR, and Matzuda index
Time Frame
Six months
Title
Fasting blood lipids
Description
Total, LDL, and HDL cholesterol, and TAG (mmol/L)
Time Frame
Six months
Title
Fasting plasma FFA
Description
mmol/L
Time Frame
Six months
Title
Fasting plasma PAI-1
Description
ng/ml
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Diabetes Allergic to phenylalanine or milk Smoking Pregnancy or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Richelsen, Professor
Organizational Affiliation
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Internal Medicine/Endocrinology C, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
36118751
Citation
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.
Results Reference
derived
PubMed Identifier
26081486
Citation
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.
Results Reference
derived
PubMed Identifier
22205311
Citation
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.
Results Reference
derived

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Effect of Carbonated Soft Drinks on the Body Weight

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