Metabolic Syndrome XNCT00561626
Effects of High-fat and Low-fat Diet on the Gut
A study testing high fat diet followed by low fat diet and low fat diet followed by high fat diet in people with Metabolic Syndrome X, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: The prevalence of the metabolic syndrome is strongly increasing in developed countries. The role of the small intestine seems important in the development of the metabolic syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome X
- What is being tested?
- high fat diet followed by low fat diet and low fat diet followed by high fat diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2008to Dec 2008
- 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age between 18 and 65 years
- body mass index (BMI) between 18 and 30 kg/m2
Who cannot join
- BMI ≤ 18 and ≥ 25 kg/m2
- Smoking
- Serum Total cholesterol > 8.0 mmol/L
- Fasting glucose > 7.0 mmol/L
- Use of any medication
- Active cardiovascular diseases like congestive heart failure or recent (<6 months) event (acute myocardial infarction, CVA)
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- Gastrointestinal diseases (like celiac disease, inflammatory bowel disease, irritable bowel disease and food allergies) or a history of any gastrointestinal disorders or complaints
- Pre-existing gallbladder disease
- Diabetes mellitus
- Familial hypercholesterolemia
- Severe medical conditions that might interfere with the study such as epilepsy, asthma, COPD and rheumatoid arthritis.
- Unstable body weight (weight gain or loss > 3 kg in the past three months)
- Impairment of renal function, as evidenced by increased serum creatinine >150 mmol/L
- Hepatic diseases as manifested by ALT, AST, GGT, total bilirubin or ALP > 2 times the upper limit of normal
- CRP values > 8.0 mg/mL
- Abuse of drugs and/or alcohol
- Participation in another biomedical study within 1 month prior to the start of this study
- Having donated blood (as blood donor) within 1 month prior to start of this study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University, Department of Human Biology
Maastricht, 6229 ER
About this study
Official title: Effects of a High-fat and a Low-fat Diet on Early Biomarkers of Metabolic Stress in Blood and Gene Expression in the Small Intestine of Healthy Subjects
Rationale: The prevalence of the metabolic syndrome is strongly increasing in developed countries. The role of the small intestine seems important in the development of the metabolic syndrome. Although it is known that a high-fat Western-style of diet has deleterious effects on (post-prandial) lipidemia and glucose homeostases, effects of such a diet on the small intestine is not known. To elucidate the role of the small intestine on the early development of the metabolic syndrome, the effects of a high-fat (HF) and a low-fat (LF) diet will be examined on gene expression in the small intestine and early biomarkers in blood of healthy subjects.
Objective: The objective of this study is to compare in healthy subjects the effects of a HF diet (40 En% fat) with those of a LF diet (20 En% fat) on early biomarkers and parameters of metabolic stress in blood and on expression of genes in the small intestine.
Read more
Additional research objectives are:
- To compare the diet-induced changes in transcriptome profile of the small intestine with more easily accessible peripheral blood mononuclear cells (PBMC)
- To establish effects of HF and LF diet on basal gut permeability and after a chenodeoxycholic acid (CDCA) load (second hit).
Study design: Randomised crossover design. The duration of the experimental periods (HF and LF diet) will be 28 days, separated by a wash out period of at least 3 weeks. At day 21 of each intervention period a postprandial test will be performed and duodenum biopsies will be taken. At day 25 and 28 of each intervention period, respectively, basal gut permeability and gut permeability after a CDCA load will be determined with a sugar recovery test.
Study population: Ten healthy men in the age of 18-60 years, without a history of any gastrointestinal disorders or complaints.
Intervention: Subjects will consume in random order:
- a HF diet (40 En% fat, 45 En% carbohydrates and 15 En% proteins)
- a LF diet (20 En% fat, 65 En% carbohydrates and 15 En% proteins)
Primary study parameters/endpoints: Potential early biomarkers of the metabolic syndrome in blood and gene expression profiles in the small intestine.
Secondary study parameters/endpoints: Parameters of the metabolic syndrome in blood, gene expression profiles in PBMC and gut permeability.
- Conditions
- Metabolic Syndrome X
- Being tested
- high fat diet followed by low fat diet, low fat diet followed by high fat diet
- 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 fat diet followed by low fat dietDietary supplement
High fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily Low fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily
low fat diet followed by high fat dietDietary supplement
Low fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily High fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Dietary Supplement: high fat diet followed by low fat diet |
| B | Experimental | Not described Receives: Dietary Supplement: low fat diet followed by high fat diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
potential early biomarkers in plasma
Measured: 3 weeks
Secondary outcomes (2)
gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC)
Measured: 3 weken
gut permeability
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionOct 2008
- Study completionDec 2008
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.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Ronald P. Mensink, Prof. Dr. Ir., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561626
- Sponsor's protocol ID
- 07-3-088
- Status last verified
- Dec 2008
- First submitted
- 20 Nov 2007
- Last updated
- 24 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a High-fat and a Low-fat Diet on Early Biomarkers of Metabolic Stress in Blood and Gene Expression in the Small Intestine of Healthy Subjects
- ClinicalTrials.gov ID
- NCT00561626
- Acronym / sponsor ID
- 07-3-088
- Conditions
- Metabolic Syndrome X
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Oct 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 21 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.
Rationale: The prevalence of the metabolic syndrome is strongly increasing in developed countries. The role of the small intestine seems important in the development of the metabolic syndrome. Although it is known that a high-fat Western-style of diet has deleterious effects on (post-prandial) lipidemia and glucose homeostases, effects of such a diet on the small intestine is not known. To elucidate the role of the small intestine on the early development of the metabolic syndrome, the effects of a high-fat (HF) and a low-fat (LF) diet will be examined on gene expression in the small intestine and early biomarkers in blood of healthy subjects.
Objective: The objective of this study is to compare in healthy subjects the effects of a HF diet (40 En% fat) with those of a LF diet (20 En% fat) on early biomarkers and parameters of metabolic stress in blood and on expression of genes in the small intestine.
Additional research objectives are:
- To compare the diet-induced changes in transcriptome profile of the small intestine with more easily accessible peripheral blood mononuclear cells (PBMC)
- To establish effects of HF and LF diet on basal gut permeability and after a chenodeoxycholic acid (CDCA) load (second hit).
Study design: Randomised crossover design. The duration of the experimental periods (HF and LF diet) will be 28 days, separated by a wash out period of at least 3 weeks. At day 21 of each intervention period a postprandial test will be performed and duodenum biopsies will be taken. At day 25 and 28 of each intervention period, respectively, basal gut permeability and gut permeability after a CDCA load will be determined with a sugar recovery test.
Study population: Ten healthy men in the age of 18-60 years, without a history of any gastrointestinal disorders or complaints.
Intervention: Subjects will consume in random order:
- a HF diet (40 En% fat, 45 En% carbohydrates and 15 En% proteins)
- a LF diet (20 En% fat, 65 En% carbohydrates and 15 En% proteins)
Primary study parameters/endpoints: Potential early biomarkers of the metabolic syndrome in blood and gene expression profiles in the small intestine.
Secondary study parameters/endpoints: Parameters of the metabolic syndrome in blood, gene expression profiles in PBMC and gut permeability.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Dietary Supplement: high fat diet followed by low fat diet |
| B | Experimental | Dietary Supplement: low fat diet followed by high fat diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age between 18 and 65 years
- body mass index (BMI) between 18 and 30 kg/m2
Key exclusion criteria (18 listed)
- BMI ≤ 18 and ≥ 25 kg/m2
- Smoking
- Serum Total cholesterol > 8.0 mmol/L
- Fasting glucose > 7.0 mmol/L
- Use of any 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 |
|---|---|---|
| high fat diet followed by low fat dietHigh fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily Low fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily | Dietary supplement | A |
| low fat diet followed by high fat dietLow fat diet : 20 Energy (En)% fat, 65 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily High fat diet : 40 Energy (En)% fat, 45 En% carbohydrates, 15 En% proteins, 250 mg cholesterol,4 weeks, daily | Dietary supplement | B |
Primary outcome
potential early biomarkers in plasma
Time frame: 3 weeks
2 secondary outcomes
gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC)
Time frame: 3 weken
gut permeability
Time frame: 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 24 Feb 2017.
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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.
Ronald P. Mensink, Prof. Dr. Ir. principal investigator
Maastricht University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high fat diet followed by low fat diet and low fat diet followed by high fat diet in people with Metabolic Syndrome X, run by Maastricht University Medical Center 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 2 inclusion and 18 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 24 Feb 2017. 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?
potential early biomarkers in plasma (time frame: 3 weeks). 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 24 Feb 2017.