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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01121003
Other study ID # Protocole 220/09
Secondary ID
Status Completed
Phase N/A
First received May 6, 2010
Last updated October 18, 2011
Start date May 2010
Est. completion date October 2011

Study information

Verified date October 2011
Source University of Lausanne
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

8 healthy male volunteers will be studied each on 3 occasions, ie

- after 4 days on a weight maintenance diet containing 5% simple sugars + low physical activity

- after 4 days on a weight maintenance diet containing 30% fructose + low physical activity

- after 4 days on a weight maintenance diet containing 30% fructose + high physical activity At the end of each of these 3 periods, fructose induced hepatic de novo lipogenesis (13C palmitate synthesis in response to ingestion of a 13C fructose load) and plasma VLDL-triglyceride kinetics (measured with a bolus of 2H-labeled glycerol) will be measured


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date October 2011
Est. primary completion date October 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 30 Years
Eligibility Inclusion Criteria:

- age between 18 and 30 years

- males

- BMI between 19 and 25

- low to moderate physical activity (< 3 sessions/week)

Exclusion Criteria:

- smoking

- consumption of alcohol>50g/week

- consumption of drugs or illicit substances

- food allergies

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Behavioral:
weight maintenance, low sugar diet

weight maintenance, high fructose diet

weight maintenance, high fructose diet+ exercise


Locations

Country Name City State
Switzerland Centre Hospitalier Universitaire Vaudois Lausanne VD

Sponsors (2)

Lead Sponsor Collaborator
University of Lausanne Centre Hospitalier Universitaire Vaudois

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hepatic de novo lipogenesis Measurement of 13C VLDL palmitate after ingestion of 13C fructose after 4 days on controlled diet+exercise No
Secondary Plasma VLDL-triglyceride kinetics Modelling of 2H5-glycerol incorporation in VLDL afetr administration of a bolus of 2H5 glycerol after 4 days on controlled diet+exercise No
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