Metabolic Syndrome XNCT00558740
Effects of Dietary Proteins on Hepatic Lipid Metabolism
An observational study of Metabolic Syndrome X, run by University of Lausanne at 1 site in Switzerland.
Trial summary
Individuals submitted to a high-fat or a high-fructose/sucrose diet develop, over a 6 day-period, several features of the metabolic syndrome, including increased plasma triglycerides, increased intrahepatic lipids, and decreased hepatic insulin sensitivity. 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 X
- What is being tested?
- high protein intake
- How many people
- 22 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2009to Apr 2009
- Phase
- Observational
- 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
Study population: Healthy volunteers
Who may be able to join
- age 18-30
- sex male
- BMI 19-25 kg/m2
- sedentary
- good physical health
Who cannot join
- family history of diabetes
- use of drugs or illicit substances
- consumption of alcohol >50 g/week
- vegetarians
- smokers
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, CH-1011
About this study
Individuals submitted to a high-fat or a high-fructose/sucrose diet develop, over a 6 day-period, several features of the metabolic syndrome, including increased plasma triglycerides, increased intrahepatic lipids, and decreased hepatic insulin sensitivity. It has been recently observed that the increase in intrahepatic lipids observed after a high fat diet is largely prevented when protein intake is concomitantly increased. This suggests that dietary protein protects the liver against some of the deleterious effects of a high fat diet. Mechanisms underlying this effect of protein may include an increased hepatic fat oxidation.
The aims of this study are:
- to evaluate the effects of dietary protein on several major pathways involved in hepatic lipid metabolism ( ketogenesis, lipid oxidation, de novo lipogenesis, VLDL-triglyceride secretion
- to determine whether the decrease in intra-hepatic lipids observed when dietary protein intake is increased are to be attributed to acute or long-term effects of proteins
Read the detailed description
This research project include three sub-studies of healthy, normal weight, young males.
Sub-study A1: The effects of acute and chronic increase in protein intake on whole body and hepatic lipid metabolism will be studied in healthy males. Two groups of 7 subjects will be recruited.
One group will be studied on three occasions, during which their metabolism will be evaluated in basal, post-absorptive conditions and over 6 hours after ingestion of mixed meal containing carbohydrate, fat (including medium chain triglycerides (MCT) labeled with 13C3 tri-octanoate), and protein.
- control: on one occasion subjects will have received an isocaloric diet (55% carbohydrate, 30% fat, 15% protein) during 4 days. On the morning of the 5th day, they will be studied for 2 hours in basal, postabsorptive conditions and over 6 hours following ingestion of a meal providing ca 10 kcal /kg body weight and containing 55% carbohydrate, 35% fat (of which 15% medium chain triglycerides (MCT) labeled with 13C3 trioctanoate, and 10% protein.
- acute increase in protein intake: on the second occasion, they will have received an isocaloric diet (55% carbohydrate, 30% fat, 15% protein) during 4 days. On the morning of the 5th day, they will be studied for 2 hours in basal, post absorptive conditions and over 6 hours following ingestion of a meal providing ca 12.5 kcal /kg body weight and containing 45% carbohydrate, 30% fat (of which 13% medium chain triglycerides (MCT) labeled with 13C3 trioctanoate, and 25% protein.
- chronic high protein intake: on the third occasion, they will have received an hypercaloric diet ( 130% energy requirement, providing 42% carbohydrate, 23% fat, 35% protein; this corresponds to the isocaloric diet given on the first two occasions, additioned with 1g/day protein) during 4 days. On the morning of the 5th day, they will be studied for 2 hours in basal, post absorptive conditions and over 6 hours following ingestion of a meal providing ca 12.5 kcal /kg body weight and containing 45% carbohydrate, 30% fat (of which 13% medium chain triglycerides (MCT) labeled with 13C3 trioctanoate) and 25% protein. The three tests will be done in a randomized order, with a washout period of at least 4 weeks between each test.
On each occasion, the following parameters will be monitored in basal conditions and after ingestion of the mixed meal.
Deuterated glucose (6,6 2H2-glucose) and glycerol (2H5 glycerol) will be infused throughout the tests. Measurements will be include:
- whole body energy expenditure and net substrate oxidation (indirect calorimetry)
- plasma glucose, free fatty acids, VLDL-TG, ketone bodies, insulin, glucagon, growth hormone
- MCT oxidation (breath 13CO2)
- Glucose and glycerol turnover
- VLDL kinetics (modelization of 2H5 incorporation into VLDL-triglycerides. Sub-study A2: A second group of 7 subjects will be studied on three occasions according to the same protocol, except that the test meal will not include MCT and that long-chain triglycerides (LCT) will be labeled with 13C3 triolein. The same metabolic parameters will be recorded, except for MCT oxidation, which will be replaced by LCT oxidation.
This sub-study will allow to evaluate the hypothesis that dietary proteins enhance whole body hepatic lipid oxidation and decrease hepatic VLDL-triglyceride secretion.
Sub-study B: The effects of acute and chronic increase in protein intake on fructose-induced hepatic de-novo lipogenesis and VLDL-triglyceride secretion will be studied in healthy males. One group of 8 subjects will be recruited.Each subject will be studied on 4 separate occasions during which their metabolism will be studied for 2 hours in basal conditions and over 6 hours after ingestion of a standard test meal containing 0.75 g/kg fructose labeled with 13C6 fructose and 0.3 or 0.8 g/kg protein.
- control: subjects will be studied after 6 days of a a high fructose diet (isocaloric diet containing 45 % complex carbohydrate, 10% sugars, 30% fat, and 15% protein, additionned with 3.0 g/kg body weight/day fructose) and measurements will be performed in basal conditions and after administration of a standard test meal with 0.3 g/kg protein.
- acute effects of protein: subjects will be studied after 6 days of a high fructose diet, and measurements will be performed in basal conditions and after administration of a standard test meal with 0.8 g/kg protein
- Chronic effects of high protein: subjects will be studied after 6 days of a high fructose diet additionned with 1g/kg body weight protein/day and after administration of a standard test meal with 0.3 g/kg protein.
- Chronic + acute effects of high protein: subjects will be studied after 6 days of a high fructose diet additionned with 1g/kg body weight protein/day and after administration of a standard test meal with 0.8 g/kg protein
Deuterated glucose (6,6 2H2 Glucose) and glycerol (2H5 glycerol) will be infused throughout the tests. Measurements will be include:
- whole body energy expenditure and net substrate oxidation (indirect calorimetry)
- plasma glucose, free fatty acids, VLDL-TG, ketone bodies, insulin, glucagon, growth hormone
- Fructose oxidation (breath 13CO2)
- Hepatic de novo lipogenesis (13C VLDL-palmitate)
- Gluconeogenesis (13C glucose)
- Glucose and glycerol turnover
- VLDL kinetics (modelization of 2H5 incorporation into VLDL-triglycerides This sub-study will allow to evaluate the hypothesis that dietary proteins inhibit hepatic de-novo lipogenesis and enhance the oxidation of fructose.
Subcutaneous adipose tissue biopsies will be obtained on two occasions, ie after high protein and control diet for analysis of gene expression.
Sub-study B3:The effects of hyperglucagonemia on fructose-induced hepatic de-novo lipogenesis and VLDL-triglyceride secretion will be studied in healthy males. One group of 6 subjects will be recruited.Each subject will be studied on 2 separate occasions during which their metabolism will be studied for 2 hours in basal conditions and over 8 hours after ingestion of a standard test meal containing 0.75 g/kg fructose labeled with 13C6 fructose and 0.3 g/kg protein.
- control: subjects will be studied after 6 days of an energy balanced diet and measurements will be performed in basal conditions and after administration of a standard test meal with 0.75g/g 13C-labelled fructose and 0.3 g/kg protein.
- acute effects of glucagon: subjects will be studied after 6 days of an energy balanced diet and measurements will be performed in basal conditions and after administration of a standard test meal with 0.75g/g 13C-labelled fructose and 0.3 g/kg protein together with a glucagon infusion (5ng/kg/min)
Deuterated glucose (6,6 2H2 Glucose) and glycerol (2H5 glycerol) will be infused throughout the tests. Measurements will include:
- whole body energy expenditure and net substrate oxidation (indirect calorimetry)
- plasma glucose, free fatty acids, VLDL-TG, ketone bodies, insulin, glucagon, growth hormone
- Fructose oxidation (breath 13CO2)
- Hepatic de novo lipogenesis (13C VLDL-palmitate)
- Gluconeogenesis (13C glucose)
- Glucose and glycerol turnover
- VLDL kinetics (modelization of 2H5 incorporation into VLDL-triglycerides This sub-study will allow to evaluate the hypothesis that dietary proteins inhibit hepatic de-novo lipogenesis and enhance the oxidation of fructose. through an increased glucagon secretion
- Conditions
- Metabolic Syndrome X
- Being tested
- high protein intake
- Keywords
- Dietary protein, Fructose, VLDL-triglycerides, Hepatic de novo lipogenesis, Lipid oxidation
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high protein intakeOther
acute high protein intake chronic (6-day) high protein intake acute+chronic high protein intake control
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Not described Receives: Other: high protein intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole body lipid oxidation Medium chain triglyceride oxidation Long chain triglyceride oxidation VLDL-triglyceride kinetics Hepatic de novo lipogenesis whole body glucose and glycerol turnover
Measured: acute effects of dietary proteins and after 4 days on a high protein day
Secondary outcomes (1)
Energy expenditure Glucagon/insulin ratio Plasma growth hormone concentrations gene expression in subcutaneous adipose tissue Plasma ketone bodies concentrations
Measured: acute effects of dietary proteins and after 4 days on a high protein day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2007 (estimated)
- Study startJan 2009
- Primary completionApr 2009
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Investigators
- l Tappy, MD, Principal investigator, University of Lausanne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558740
- Sponsor's protocol ID
- protocol 66/07/CE/FBM
- Other IDs
- SNF 310000-109737
- Status last verified
- Nov 2009
- First submitted
- 14 Nov 2007
- Last updated
- 10 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dietary Proteins on Hepatic Lipid Metabolism
- ClinicalTrials.gov ID
- NCT00558740
- Acronym / sponsor ID
- protocol 66/07/CE/FBM
- Conditions
- Metabolic Syndrome X
- Keywords
- Dietary protein, Fructose, VLDL-triglycerides, Hepatic de novo lipogenesis, Lipid oxidation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of LausanneUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern
- Study start
- Jan 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 15 Nov 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.
Individuals submitted to a high-fat or a high-fructose/sucrose diet develop, over a 6 day-period, several features of the metabolic syndrome, including increased plasma triglycerides, increased intrahepatic lipids, and decreased hepatic insulin sensitivity. It has been recently observed that the increase in intrahepatic lipids observed after a high fat diet is largely prevented when protein intake is concomitantly increased. This suggests that dietary protein protects the liver against some of the deleterious effects of a high fat diet. Mechanisms underlying this effect of protein may include an increased hepatic fat oxidation.
The aims of this study are:
- to evaluate the effects of dietary protein on several major pathways involved in hepatic lipid metabolism ( ketogenesis, lipid oxidation, de novo lipogenesis, VLDL-triglyceride secretion
- to determine whether the decrease in intra-hepatic lipids observed when dietary protein intake is increased are to be attributed to acute or long-term effects of proteins
Detailed description
This research project include three sub-studies of healthy, normal weight, young males.
Sub-study A1: The effects of acute and chronic increase in protein intake on whole body and hepatic lipid metabolism will be studied in healthy males. Two groups of 7 subjects will be recruited.
One group will be studied on three occasions, during which their metabolism will be evaluated in basal, post-absorptive conditions and over 6 hours after ingestion of mixed meal containing carbohydrate, fat (including medium chain triglycerides (MCT) labeled with 13C3 tri-octanoate), and protein.
- control: on one occasion subjects will have received an isocaloric diet (55% carbohydrate, 30% fat, 15% protein) during 4 days. On the morning of the 5th day, they will be studied for 2 hours in basal, postabsorptive conditions and over 6 hours following ingestion of a meal providing ca 10 kcal /kg body weight and containing 55% carbohydrate, 35% fat (of which 15% medium chain triglycerides (MCT) labeled with 13C3 trioctanoate, and 10% protein.
- acute increase in protein intake: on the second occasion, they will have received an isocaloric diet (55% carbohydrate, 30% fat, 15% protein) during 4 days. On the morning of the 5th day, they will be studied for 2 hours in basal, post absorptive conditions and over 6 hours following ingestion of a meal providing ca 12.5 kcal /kg body weight and containing 45% carbohydrate, 30% fat (of which 13% medium chain triglycerides (MCT) labeled with 13C3 trioctanoate, and 25% protein.
- chronic high protein intake: on the third occasion, they will have received an hypercaloric diet ( 130% energy requirement, providing 42% carbohydrate, 23% fat, 35% protein; this corresponds to the isocaloric diet given on the first two occasions, additioned with 1g/day protein) during 4 days. On the morning of the 5th day, they will be studied for 2 hours in basal, post absorptive conditions and over 6 hours following ingestion of a meal providing ca 12.5 kcal /kg body weight and containing 45% carbohydrate, 30% fat (of which 13% medium chain triglycerides (MCT) labeled with 13C3 trioctanoate) and 25% protein. The three tests will be done in a randomized order, with a washout period of at least 4 weeks between each test.
On each occasion, the following parameters will be monitored in basal conditions and after ingestion of the mixed meal.
Deuterated glucose (6,6 2H2-glucose) and glycerol (2H5 glycerol) will be infused throughout the tests. Measurements will be include:
- whole body energy expenditure and net substrate oxidation (indirect calorimetry)
- plasma glucose, free fatty acids, VLDL-TG, ketone bodies, insulin, glucagon, growth hormone
- MCT oxidation (breath 13CO2)
- Glucose and glycerol turnover
- VLDL kinetics (modelization of 2H5 incorporation into VLDL-triglycerides. Sub-study A2: A second group of 7 subjects will be studied on three occasions according to the same protocol, except that the test meal will not include MCT and that long-chain triglycerides (LCT) will be labeled with 13C3 triolein. The same metabolic parameters will be recorded, except for MCT oxidation, which will be replaced by LCT oxidation.
This sub-study will allow to evaluate the hypothesis that dietary proteins enhance whole body hepatic lipid oxidation and decrease hepatic VLDL-triglyceride secretion.
Sub-study B: The effects of acute and chronic increase in protein intake on fructose-induced hepatic de-novo lipogenesis and VLDL-triglyceride secretion will be studied in healthy males. One group of 8 subjects will be recruited.Each subject will be studied on 4 separate occasions during which their metabolism will be studied for 2 hours in basal conditions and over 6 hours after ingestion of a standard test meal containing 0.75 g/kg fructose labeled with 13C6 fructose and 0.3 or 0.8 g/kg protein.
- control: subjects will be studied after 6 days of a a high fructose diet (isocaloric diet containing 45 % complex carbohydrate, 10% sugars, 30% fat, and 15% protein, additionned with 3.0 g/kg body weight/day fructose) and measurements will be performed in basal conditions and after administration of a standard test meal with 0.3 g/kg protein.
- acute effects of protein: subjects will be studied after 6 days of a high fructose diet, and measurements will be performed in basal conditions and after administration of a standard test meal with 0.8 g/kg protein
- Chronic effects of high protein: subjects will be studied after 6 days of a high fructose diet additionned with 1g/kg body weight protein/day and after administration of a standard test meal with 0.3 g/kg protein.
- Chronic + acute effects of high protein: subjects will be studied after 6 days of a high fructose diet additionned with 1g/kg body weight protein/day and after administration of a standard test meal with 0.8 g/kg protein
Deuterated glucose (6,6 2H2 Glucose) and glycerol (2H5 glycerol) will be infused throughout the tests. Measurements will be include:
- whole body energy expenditure and net substrate oxidation (indirect calorimetry)
- plasma glucose, free fatty acids, VLDL-TG, ketone bodies, insulin, glucagon, growth hormone
- Fructose oxidation (breath 13CO2)
- Hepatic de novo lipogenesis (13C VLDL-palmitate)
- Gluconeogenesis (13C glucose)
- Glucose and glycerol turnover
- VLDL kinetics (modelization of 2H5 incorporation into VLDL-triglycerides This sub-study will allow to evaluate the hypothesis that dietary proteins inhibit hepatic de-novo lipogenesis and enhance the oxidation of fructose.
Subcutaneous adipose tissue biopsies will be obtained on two occasions, ie after high protein and control diet for analysis of gene expression.
Sub-study B3:The effects of hyperglucagonemia on fructose-induced hepatic de-novo lipogenesis and VLDL-triglyceride secretion will be studied in healthy males. One group of 6 subjects will be recruited.Each subject will be studied on 2 separate occasions during which their metabolism will be studied for 2 hours in basal conditions and over 8 hours after ingestion of a standard test meal containing 0.75 g/kg fructose labeled with 13C6 fructose and 0.3 g/kg protein.
- control: subjects will be studied after 6 days of an energy balanced diet and measurements will be performed in basal conditions and after administration of a standard test meal with 0.75g/g 13C-labelled fructose and 0.3 g/kg protein.
- acute effects of glucagon: subjects will be studied after 6 days of an energy balanced diet and measurements will be performed in basal conditions and after administration of a standard test meal with 0.75g/g 13C-labelled fructose and 0.3 g/kg protein together with a glucagon infusion (5ng/kg/min)
Deuterated glucose (6,6 2H2 Glucose) and glycerol (2H5 glycerol) will be infused throughout the tests. Measurements will include:
- whole body energy expenditure and net substrate oxidation (indirect calorimetry)
- plasma glucose, free fatty acids, VLDL-TG, ketone bodies, insulin, glucagon, growth hormone
- Fructose oxidation (breath 13CO2)
- Hepatic de novo lipogenesis (13C VLDL-palmitate)
- Gluconeogenesis (13C glucose)
- Glucose and glycerol turnover
- VLDL kinetics (modelization of 2H5 incorporation into VLDL-triglycerides This sub-study will allow to evaluate the hypothesis that dietary proteins inhibit hepatic de-novo lipogenesis and enhance the oxidation of fructose. through an increased glucagon secretion
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | Other: high protein intake |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers
Key inclusion criteria (5 listed)
- age 18-30
- sex male
- BMI 19-25 kg/m2
- sedentary
- good physical health
Key exclusion criteria (5 listed)
- family history of diabetes
- use of drugs or illicit substances
- consumption of alcohol >50 g/week
- vegetarians
- smokers
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 |
|---|---|---|
| high protein intakeacute high protein intake chronic (6-day) high protein intake acute+chronic high protein intake control | Other | healthy volunteers |
Primary outcome
Whole body lipid oxidation Medium chain triglyceride oxidation Long chain triglyceride oxidation VLDL-triglyceride kinetics Hepatic de novo lipogenesis whole body glucose and glycerol turnover
Time frame: acute effects of dietary proteins and after 4 days on a high protein day
1 secondary outcome
Energy expenditure Glucagon/insulin ratio Plasma growth hormone concentrations gene expression in subcutaneous adipose tissue Plasma ketone bodies concentrations
Time frame: acute effects of dietary proteins and after 4 days on a high protein day
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 10 Feb 2012.
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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.
l 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?
An observational study of Metabolic Syndrome X, 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 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 10 Feb 2012. 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?
Whole body lipid oxidation Medium chain triglyceride oxidation Long chain triglyceride oxidation VLDL-triglyceride kinetics Hepatic de novo lipogenesis whole body glucose and glycerol turnover (time frame: acute effects of dietary proteins and after 4 days on a high protein day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2012.