Metabolic SyndromeAMINOFRUCTNCT01119989
Effects of an Amino-acid Supplement on Hepatic Lipid Metabolism
A study testing amino-acid + fructose in people with Metabolic Syndrome, run by University of Lausanne at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- amino-acid + fructose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2010to Dec 2011
- 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 18 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-30 years
- sex: males
- BMI between 19 and 25 kg/m2
- less than 3 30min- exercise session/week
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: 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
- Conditions
- Metabolic Syndrome
- Being tested
- Fructose+maltodextrin placebo, amino-acid + fructose
- Keywords
- hepatic fat content, hepatic de novo lipogenesis
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructose+maltodextrin placeboDietary supplement
amino-acid + fructoseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| weight maintenance diet | No intervention | Not described |
| weight maintenance + fructose | Placebo comparator | Not described Receives: Dietary Supplement: Fructose+maltodextrin placebo |
| weight maintenance diet + fructose and amino-acid | Experimental | Not described Receives: Dietary Supplement: amino-acid + fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
intrahepatic lipids
Measured: after 6 days on each controlled diet
Secondary outcomes (1)
13C palmitate synthesis
Measured: after 6 days on each controlled diet
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2010 (estimated)
- Study startMay 2010
- Primary completionMar 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01119989
- Sponsor's protocol ID
- protocole 51/10
- Acronym
- AMINOFRUCT
- Status last verified
- May 2018
- First submitted
- 6 May 2010
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Theytaz F, Noguchi Y, Egli L, Campos V, Buehler T, Hodson L, Patterson BW, Nishikata N, Kreis R, Mittendorfer B, Fielding B, Boesch C, Tappy L. Effects of supplementation with essential amino acids on intrahepatic lipid concentrations during fructose overfeeding in humans. Am J Clin Nutr. 2012 Nov;96(5):1008-16. doi: 10.3945/ajcn.112.035139. Epub 2012 Oct 3.
PubMed 23034968
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Supplementation With Amino-acids on Hepatic Lipid Metabolism
- ClinicalTrials.gov ID
- NCT01119989
- Acronym / sponsor ID
- AMINOFRUCT / protocole 51/10
- Conditions
- Metabolic Syndrome
- Keywords
- hepatic fat content, hepatic de novo lipogenesis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- May 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| weight maintenance diet | No intervention | – |
| weight maintenance + fructose | Placebo comparator | Dietary Supplement: Fructose+maltodextrin placebo |
| weight maintenance diet + fructose and amino-acid | Experimental | Dietary Supplement: amino-acid + fructose |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age 18-30 years
- sex: males
- BMI between 19 and 25 kg/m2
- less than 3 30min- exercise session/week
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructose+maltodextrin placebo | Dietary supplement | weight maintenance + fructose |
| amino-acid + fructose | Dietary supplement | weight maintenance diet + fructose and amino-acid |
Primary outcome
intrahepatic lipids
Time frame: after 6 days on each controlled diet
1 secondary outcome
13C palmitate synthesis
Time frame: after 6 days on each controlled diet
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Derived from this study: PubMed 23034968Theytaz F, Noguchi Y, Egli L, Campos V, Buehler T, Hodson L, Patterson BW, Nishikata N, Kreis R, Mittendorfer B, Fielding B, Boesch C, Tappy L. Effects of supplementation with essential amino acids on intrahepatic lipid concentrations during fructose overfeeding in humans. Am J Clin Nutr. 2012 Nov;96(5):1008-16. doi: 10.3945/ajcn.112.035139. Epub 2012 Oct 3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amino-acid + fructose in people with Metabolic Syndrome, run by University of Lausanne at 1 site in Switzerland.
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 5 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 4 May 2018. 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 Switzerland. 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?
intrahepatic lipids (time frame: after 6 days on each controlled diet). 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 NCT01119989, which also lists 1 linked publication.
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 4 May 2018.