- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01119989
Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism (AMINOFRUCT)
May 1, 2018 updated by: Luc Tappy, MD, University of Lausanne
Effects of a Supplementation With Amino-acids on Hepatic Lipid Metabolism
10 healthy male volunteers will be studied after
- a 6 day weight maintenance, balanced diet
- a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day
- a 6 days weight maintenance, balanced diet supplemented with 3 grams fructose/kg body weight/day and 20g amino-acids per day At the end of each 6 days period, the following measurements will be obtained
- intrahepatic lipids (1H-MRS)
- metabolic effects of fructose ingestion (measurement of substrate oxidation, gluconeogenesis from fructose, palmitate synthesis from fructose, plasma VLDL-kinetics)
This is a randomized, double blinded study
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
VD
-
Lausanne, VD, Switzerland, CH-1011
- Centre Hospitalier Universitaire Vaudois
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- age 18-30 years
- sex: males
- BMI between 19 and 25 kg/m2
- less than 3 30min- exercise session/week
Exclusion Criteria:
- smokers
- alcohol consumption more than 50g/week
- consumption of drugs
- history of diabetes in first degree relatives
- presence of ferro-magnetic prosthesis, cardiac pacemakers, or any contra-indication to NMR
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: weight maintenance diet
|
|
PLACEBO_COMPARATOR: weight maintenance + fructose
|
|
EXPERIMENTAL: weight maintenance diet + fructose and amino-acid
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
intrahepatic lipids
Time Frame: after 6 days on each controlled diet
|
after 6 days on each controlled diet
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
13C palmitate synthesis
Time Frame: after 6 days on each controlled diet
|
after 6 days on each controlled diet
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (ACTUAL)
March 1, 2011
Study Completion (ACTUAL)
December 1, 2011
Study Registration Dates
First Submitted
May 6, 2010
First Submitted That Met QC Criteria
May 7, 2010
First Posted (ESTIMATE)
May 10, 2010
Study Record Updates
Last Update Posted (ACTUAL)
May 4, 2018
Last Update Submitted That Met QC Criteria
May 1, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- protocole 51/10
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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