Metabolic Syndrome XMACRONUTRNCT00523562
Effects of Macronutrients on Hepatic Lipids, Plasma Triglycerides, and Insulin Sensitivity
A study testing diet intervention in people with Metabolic Syndrome X and Liver Diseases, run by University of Lausanne at 1 site in Switzerland.
Trial summary
The purpose of this study is to assess how the macronutrient composition of the diet effects lipid and glucose metabolism intrahepatic lipids insulin sensitivity in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and offsprings of patients with type 2 diabetes mellitus). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X, Liver Diseases
- What is being tested?
- diet intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2006to Jan 2009
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Males and females
- Age 18-40
- Informed consent obtained
- Subgroup with overweight (body mass index [BMI] > 25)
- Subgroup with family history of type 2 diabetes mellitus
Who cannot join
- Smokers
- Alcohol intake > 30g/day
- Drug abuse
- Diabetes mellitus
- Any concurrent medication
- Having a pacemaker
- History of orthopedic surgery
- History of metal foreign bodies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, CH-1011
About this study
Official title: Study of the Role of Insulin Resistance in the Pathogenesis of the Metabolic Syndrome and of Non-alcoholic Steatohepatitis
The purpose of this study is to assess how the macronutrient composition of the diet effects
- lipid and glucose metabolism
- intrahepatic lipids
- insulin sensitivity in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and offsprings of patients with type 2 diabetes mellitus).
Read the detailed description
The study is aimed at assessing the effects of changes in total energy, sugars, lipids, and protein intake on intrahepatic lipids, plasma lipids, and hepatic and whole body insulin resistance in
- lean men and women with no family history of diabetes
- overweight men and women
- lean men with a family history of type 2 diabetes
Subjects are studied after a 6-day period of
- isocaloric diet with 100% calorie requirement, of which 55% carbohydrate, 15% protein, and 30% fat)
- the same isocaloric diet supplemented with 3g/kg body weight/day fructose
- hypercaloric high fat diet with 130% energy requirement, of which 55% carbohydrate, 15% protein, 60% fat
- hypercaloric high fat+protein diet with 145% energy requirement, of which 55% carbohydrate, 30% protein, 60% fat
Measurements performed after 6 days on each diet include
- intrahepatic and intramyocellular lipids (1H-MRS)
- hepatic and whole body insulin sensitivity (hyperinsulinemic-euglycemic clamp)
- body weight
- plasma concentrations of hormones and substrates
- gene expression profile in skeletal muscle (vastus lateralis) and adipose tissue (subcutaneous abdominal)
- Conditions
- Metabolic Syndrome X, Liver Diseases
- Being tested
- diet intervention
- Keywords
- fructose, dietary lipids, dietary proteins, hepatic steatosis, insulin resistance, Healthy humans, overweight humans, obese humans
- Medical subject headings
- Metabolic Syndrome, Liver Diseases, Fatty Liver, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet interventionOther
controlled hypercaloric high fructose, high fat, or high fat/high protein diet
| Study group | Role | What they receive |
|---|---|---|
| normal weight male high fructose diet | Experimental | Effects of diet intervention " high fructose" in normal weight subjects Receives: Other: diet intervention |
| offsprings of T2DM high fructose diet | Experimental | Effect of diet intervention "high fructose" in healthy non-obese offsprings of patients with type 2 diabetes Receives: Other: diet intervention |
| normal weight subjects high fat diet | Experimental | effects of diet intervention "high fat" in healthy male subjects Receives: Other: diet intervention |
| Normal weight high fat+protein diet | Experimental | effect of diet intervention "high fat + protein" subjects in healthy male subjects Receives: Other: diet intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma triglycerides
Measured: 6 days
intra-hepatic lipids
Measured: 6 days
insulin mediated glucose disposal
Measured: 6 days
Secondary outcomes (3)
lipid oxidation
Measured: 6 days
plasma beta-hydroxybutyrate
Measured: 6 days
gene expression in skeletal muscle and adipose tissue
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJul 2006
- Primary completionApr 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic Syndrome XStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luc Tappy, MD, University of Lausanne
- Investigators
- Luc Tappy, MD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523562
- Sponsor's protocol ID
- protocol 140/04/CE/FBM
- Acronym
- MACRONUTR
- Status last verified
- Jun 2018
- First submitted
- 30 Aug 2007
- Last updated
- 14 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bortolotti M, Kreis R, Debard C, Cariou B, Faeh D, Chetiveaux M, Ith M, Vermathen P, Stefanoni N, Le KA, Schneiter P, Krempf M, Vidal H, Boesch C, Tappy L. High protein intake reduces intrahepatocellular lipid deposition in humans. Am J Clin Nutr. 2009 Oct;90(4):1002-10. doi: 10.3945/ajcn.2008.27296. Epub 2009 Aug 26.
PubMed 19710199Le KA, Ith M, Kreis R, Faeh D, Bortolotti M, Tran C, Boesch C, Tappy L. Fructose overconsumption causes dyslipidemia and ectopic lipid deposition in healthy subjects with and without a family history of type 2 diabetes. Am J Clin Nutr. 2009 Jun;89(6):1760-5. doi: 10.3945/ajcn.2008.27336. Epub 2009 Apr 29.
PubMed 19403641
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Role of Insulin Resistance in the Pathogenesis of the Metabolic Syndrome and of Non-alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT00523562
- Acronym / sponsor ID
- MACRONUTR / protocol 140/04/CE/FBM
- Conditions
- Metabolic Syndrome X, Liver Diseases
- Keywords
- fructose, dietary lipids, dietary proteins, hepatic steatosis, insulin resistance, Healthy humans, overweight humans, obese humans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Apr 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 31 Aug 2007 (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.
The purpose of this study is to assess how the macronutrient composition of the diet effects
- lipid and glucose metabolism
- intrahepatic lipids
- insulin sensitivity in healthy lean subjects and in subjects with a high metabolic risk (ie overweight and offsprings of patients with type 2 diabetes mellitus).
Detailed description
The study is aimed at assessing the effects of changes in total energy, sugars, lipids, and protein intake on intrahepatic lipids, plasma lipids, and hepatic and whole body insulin resistance in
- lean men and women with no family history of diabetes
- overweight men and women
- lean men with a family history of type 2 diabetes
Subjects are studied after a 6-day period of
- isocaloric diet with 100% calorie requirement, of which 55% carbohydrate, 15% protein, and 30% fat)
- the same isocaloric diet supplemented with 3g/kg body weight/day fructose
- hypercaloric high fat diet with 130% energy requirement, of which 55% carbohydrate, 15% protein, 60% fat
- hypercaloric high fat+protein diet with 145% energy requirement, of which 55% carbohydrate, 30% protein, 60% fat
Measurements performed after 6 days on each diet include
- intrahepatic and intramyocellular lipids (1H-MRS)
- hepatic and whole body insulin sensitivity (hyperinsulinemic-euglycemic clamp)
- body weight
- plasma concentrations of hormones and substrates
- gene expression profile in skeletal muscle (vastus lateralis) and adipose tissue (subcutaneous abdominal)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| normal weight male high fructose diet | Experimental | Other: diet interventionEffects of diet intervention " high fructose" in normal weight subjects |
| offsprings of T2DM high fructose diet | Experimental | Other: diet interventionEffect of diet intervention "high fructose" in healthy non-obese offsprings of patients with type 2 diabetes |
| normal weight subjects high fat diet | Experimental | Other: diet interventioneffects of diet intervention "high fat" in healthy male subjects |
| Normal weight high fat+protein diet | Experimental | Other: diet interventioneffect of diet intervention "high fat + protein" subjects in healthy male subjects |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Males and females
- Age 18-40
- Informed consent obtained
- Subgroup with overweight (body mass index [BMI] > 25)
- Subgroup with family history of type 2 diabetes mellitus
Key exclusion criteria (8 listed)
- Smokers
- Alcohol intake > 30g/day
- Drug abuse
- Diabetes mellitus
- Any concurrent medication
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 |
|---|---|---|
| diet interventioncontrolled hypercaloric high fructose, high fat, or high fat/high protein diet | Other | Normal weight high fat+protein diet, normal weight male high fructose diet, normal weight subjects high fat diet, offsprings of T2DM high fructose diet |
Primary outcome
plasma triglycerides
Time frame: 6 days
intra-hepatic lipids
Time frame: 6 days
insulin mediated glucose disposal
Time frame: 6 days
3 secondary outcomes
lipid oxidation
Time frame: 6 days
plasma beta-hydroxybutyrate
Time frame: 6 days
gene expression in skeletal muscle and adipose tissue
Time frame: 6 days
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 14 Jun 2018.
- Derived from this study: PubMed 19710199Bortolotti M, Kreis R, Debard C, Cariou B, Faeh D, Chetiveaux M, Ith M, Vermathen P, Stefanoni N, Le KA, Schneiter P, Krempf M, Vidal H, Boesch C, Tappy L. High protein intake reduces intrahepatocellular lipid deposition in humans. Am J Clin Nutr. 2009 Oct;90(4):1002-10. doi: 10.3945/ajcn.2008.27296. Epub 2009 Aug 26.
- Derived from this study: PubMed 19403641Le KA, Ith M, Kreis R, Faeh D, Bortolotti M, Tran C, Boesch C, Tappy L. Fructose overconsumption causes dyslipidemia and ectopic lipid deposition in healthy subjects with and without a family history of type 2 diabetes. Am J Clin Nutr. 2009 Jun;89(6):1760-5. doi: 10.3945/ajcn.2008.27336. Epub 2009 Apr 29.
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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.
Luc Tappy, MD principal investigator
University of Lausanne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet intervention in people with Metabolic Syndrome X and Liver Diseases, 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 5 inclusion and 8 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 14 Jun 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. 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?
plasma triglycerides (time frame: 6 days). The study lists 3 primary outcomes in all. 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 NCT00523562, which also lists 2 linked publications.
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 14 Jun 2018.