- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01733563
Sugar Sweetened Beverages (SSB)- Effects on Metabolism
Effects of Carbohydrate Containing Diets on Lipid Metabolism & Fatty Acid Oxidation in Healthy Young Men - a Randomized, Double-Blinded Study.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ZH
-
Zurich, ZH, Switzerland, 8091
- University Hospital Zurich, Endocrinology and Diabetology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Healthy male volunteers aged 18-30
- BMI between 19-24 kg/m2
- Non-smoker
Exclusion criteria:
- Acute or chronic infections, malignant disease, renal, hepatic (more than two-fold increased transaminases), pulmonary, neurological (epilepsy) or psychiatric diseases, manifested atherosclerosis, or any other disease precluding participation in the study.
- Diabetes
- Known alcohol, substance or drug abuse, concomitant medication
- More than three hours of physical exercise per week
- Consumption of more than 2 times 3 dl SSB daily
- Subjects likely to fail to comply with the study protocol
- Subjects who do not give informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: fructose sweetened beverage
Soft drink consumption: Subjects have to drink a fructose sweetened beverage (3x 200ml per day, 13.3g fructose/100ml) during 7 weeks |
|
Experimental: glucose sweetened beverage
Soft drink consumption: Subjects have to drink a glucose sweetened beverage (3x 200ml per day, 13.3g glucose/100ml) during 7 weeks |
|
Experimental: sucrose sweetened beverage
Soft drink consumption: Subjects have to drink a sucrose sweetened beverage (3x 200ml per day, 13.3g sucrose/100ml) during 7 weeks |
|
Experimental: No change of eating habits
No Soft drink consumption (no soft drink diet): Subjects do not change their eating habits during 7 weeks |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipogenesis
Time Frame: After total 6 weeks dietary intervention
|
Measurement of lipogenesis is based on i. v. administration of stable isotope labelled acetate (1,2-13C-acetate).
13C incorporation into palmitate is quantified by mass-spectrometry.
13C incorporation correlates to the rate of fatty acid synthesis.
|
After total 6 weeks dietary intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lipolysis
Time Frame: After total 6 weeks dietary intervention
|
Measurements using stable isotopes
|
After total 6 weeks dietary intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Waist/Hip Ratio
Time Frame: After total 6 weeks dietary intervention
|
Measurement waist/hip ratio using a nonstretchable band
|
After total 6 weeks dietary intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Philipp Gerber, MD, University Hospital Zurich, Endocrinology and Diabetology
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SSB-Effects on metabolism
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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