Hepatic Fat AccumulationLiF-ProNCT01354626
Dietary Protein and Hepatic Fat Accumulation
A study testing dietary protein and low-protein in people with Hepatic Fat Accumulation and Nonalcoholic Fatty Liver Disease, run by Wageningen University at 1 site in Netherlands.
Trial summary
The objective of this study is to investigate the potential beneficial effect of increasing protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Fat Accumulation, Nonalcoholic Fatty Liver Disease
- What is being tested?
- dietary protein and low-protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2011to Mar 2012
- 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
- Healthy
- body mass index (BMI) 18-25 kg/ m2;
- stable dietary habits;
- physical activity levels.
- caucasian
Who cannot join
- Unable or unwilling to comply with study procedures;
- not caucasian
- Unstable body weight (weight gain or loss > 3 kg in the past three months);
- Moderate intense physical activity (exercise) for more than 4 hours/week;
- (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer;
- Family history of diabetes mellitus;
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- Use of medication, except incidental use of paracetamol;
- Abuse of drugs;
- Alcohol consumption of more than 14 glasses per week;
- Participation in another biomedical study within 1 months prior to the first screening visit;
- Contraindications to MRI scanning. These contraindications include patients with one of the following conditions:
- Claustrophobia;
- Central nervous system aneurysm clips;
- Implanted neural stimulator;
- Implanted cardiac pacemaker or defibrillator;
- Cochlear implant;
- Ocular foreign body (e.g. metal shavings);
- Insulin pump;
- Metal shrapnel or bullet;
- Or metal containing corpora aliena in the eye of brains.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University, Division of Human Nutrition
Wageningen, Gelderland, 6703 HD
About this study
Official title: Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism
The objective of this study is to investigate the potential beneficial effect of increasing protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.
The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced lipid accumulation.
- Being tested
- dietary protein, low-protein
- Keywords
- Hepatic fat accumulation, Dietary protein, NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary proteinOther
Also called diet
in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided
low-proteinOther
Also called diet
The control group will get a diet which is according to healthy eating guidelines.
| Study group | Role | What they receive |
|---|---|---|
| High fat diets | Experimental | High-fat-Low-protein or High-fat-high-protein Receives: Other: dietary protein |
| Control group | Other | Low-protein-low-fat (according to healthy eating guidelines) Receives: Other: low-protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
hepatic fat accumulation
Measured: baseline, 2 weeks, 4 weeks
Secondary outcomes (6)
Biomarkers of liver function/hepatic steatosis
Biomarkers of liver function/hepatic steatosis: ALT, AST, C-reactive protein
Measured: baseline, 2 weeks, 4 weeks
Circulating cytokines
adiponectin, TNF-α
Measured: baseline, 2 weeks, 4 weeks
Postprandial lipid metabolism
Postprandial lipid metabolism will be assessed by means of a meal challenge with the use of stable isotope tracer
Measured: 2 weeks, 4 weeks
Glucose homeostasis
Glucose homeostasis will be assessed with the homeostatic model assessment (HOMA) index in fasting blood samples. In addition dynamic indexes will be determined from the meal challenge.
Measured: baseline, 2 weeks, 4 weeks
Adipose tissue gene expression
Measured: 2 weeks, 4 weeks
Peripheral blood mononuclear cells gene expression (PBMC's).
Measured: baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2011 (estimated)
- Study startAug 2011
- Primary completionMar 2012
- Study completionMar 2012
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 Hepatic Fat AccumulationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01354626
- Sponsor's protocol ID
- LiF-Pro
- Acronym
- LiF-Pro
- Status last verified
- Mar 2012
- First submitted
- 13 May 2011
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Rietman A, Schwarz J, Blokker BA, Siebelink E, Kok FJ, Afman LA, Tome D, Mensink M. Increasing protein intake modulates lipid metabolism in healthy young men and women consuming a high-fat hypercaloric diet. J Nutr. 2014 Aug;144(8):1174-80. doi: 10.3945/jn.114.191072. Epub 2014 Jun 4.
PubMed 24899158
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Increasing Dietary Protein on Hepatic Fat Accumulation and Postprandial Metabolism
- ClinicalTrials.gov ID
- NCT01354626
- Acronym / sponsor ID
- LiF-Pro / LiF-Pro
- Keywords
- Hepatic fat accumulation, Dietary protein, NAFLD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 17 May 2011 (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 objective of this study is to investigate the potential beneficial effect of increasing protein in the diet in order to decrease hepatic lipid accumulation on a high-fat diet.
The investigators hypothesize that increasing protein in a high-fat diet suppresses lipid accumulation in the liver, and that changes in (hepatic) fat handling underlie this reduced lipid accumulation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High fat diets | Experimental | Other: dietary proteinHigh-fat-Low-protein or High-fat-high-protein |
| Control group | Other | Other: low-proteinLow-protein-low-fat (according to healthy eating guidelines) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- body mass index (BMI) 18-25 kg/ m2;
- stable dietary habits;
- physical activity levels.
- caucasian
Key exclusion criteria (20 listed)
- Unable or unwilling to comply with study procedures;
- not caucasian
- Unstable body weight (weight gain or loss > 3 kg in the past three months);
- Moderate intense physical activity (exercise) for more than 4 hours/week;
- (Chronic) disease which might influence the study outcomes e.g. diabetes mellitus or any other endocrine disorder, active cardiovascular disease, hepatic disease, renal disease, cancer;
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 |
|---|---|---|
| dietary proteinAlso: dietin the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided | Other | High fat diets |
| low-proteinAlso: dietThe control group will get a diet which is according to healthy eating guidelines. | Other | Control group |
Primary outcome
hepatic fat accumulation
Time frame: baseline, 2 weeks, 4 weeks
6 secondary outcomes
Biomarkers of liver function/hepatic steatosis
Time frame: baseline, 2 weeks, 4 weeks
Circulating cytokines
Time frame: baseline, 2 weeks, 4 weeks
Postprandial lipid metabolism
Time frame: 2 weeks, 4 weeks
Glucose homeostasis
Time frame: baseline, 2 weeks, 4 weeks
Adipose tissue gene expression
Time frame: 2 weeks, 4 weeks
Peripheral blood mononuclear cells gene expression (PBMC's).
Time frame: baseline, 2 weeks, 4 weeks
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 15 Mar 2012.
- Derived from this study: PubMed 24899158Rietman A, Schwarz J, Blokker BA, Siebelink E, Kok FJ, Afman LA, Tome D, Mensink M. Increasing protein intake modulates lipid metabolism in healthy young men and women consuming a high-fat hypercaloric diet. J Nutr. 2014 Aug;144(8):1174-80. doi: 10.3945/jn.114.191072. Epub 2014 Jun 4.
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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 dietary protein and low-protein in people with Hepatic Fat Accumulation and Nonalcoholic Fatty Liver Disease, run by Wageningen University at 1 site in Netherlands.
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 20 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 15 Mar 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 Netherlands. 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?
hepatic fat accumulation (time frame: baseline, 2 weeks, 4 weeks). 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 NCT01354626, 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 15 Mar 2012.