- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00561626
Effects of High-fat and Low-fat Diet on the Gut
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.
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 Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Maastricht, Netherlands, 6229 ER
- Maastricht University, Department of Human Biology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age between 18 and 65 years
- body mass index (BMI) between 18 and 30 kg/m2
Exclusion Criteria:
- 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)
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: A
|
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
|
Experimental: B
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
potential early biomarkers in plasma
Time Frame: 3 weeks
|
3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC)
Time Frame: 3 weken
|
3 weken
|
gut permeability
Time Frame: 4 weeks
|
4 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ronald P. Mensink, Prof. Dr. Ir., Maastricht University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-3-088
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Metabolic Syndrome X
-
The Catholic University of KoreaCompletedMetabolic Syndrome X | Metabolic Cardiovascular Syndrome | Insulin Resistance Syndrome X | Dysmetabolic Syndrome XKorea, Republic of
-
Universidad de los Andes, ChileCompleted
-
SanofiBristol-Myers SquibbCompletedMetabolic Syndrome xUnited States
-
Federal University of São PauloCompletedPhysical Activity | Endothelial Dysfunction | Metabolic Syndrome xBrazil
-
Midwest Biomedical Research FoundationSuspended
-
Instituto de Seguridad y Servicios Sociales de...Enrolling by invitationCardiovascular Diseases | Mediterranean Diet | Metabolic Syndrome xMexico
-
Wake Forest University Health SciencesBrigham and Women's HospitalCompletedDiabetes | Metabolic Syndrome xUnited States
-
University of PennsylvaniaAbbottCompletedMetabolic Syndrome xUnited States
-
Queen Margaret UniversityUnknownCardiovascular Diseases | Metabolic Syndrome XUnited Kingdom
-
Arne AstrupUniversity of Aarhus; University Hospital, Gentofte, Copenhagen; Technical University...CompletedMetabolic Syndrome XDenmark
Clinical Trials on high fat diet followed by low fat diet
-
Rutgers, The State University of New JerseyCompleted
-
Zhejiang UniversityNational Natural Science Foundation of China; Chinese PLA General Hospital; National...Completed
-
Laval UniversityRecruiting
-
Tufts UniversityCompletedDyslipidemia | Impaired Glucose Tolerance
-
Oregon Health and Science UniversityNational Institutes of Health (NIH)Recruiting
-
UCSF Benioff Children's Hospital OaklandNational Cattlemen's Beef AssociationCompletedHealthy | Cardiovascular Disease | Atherogenic DyslipidemiaUnited States
-
Hvidovre University HospitalUniversity of Copenhagen; Danish Research Centre for Magnetic ResonanceCompletedDiabetes | Metabolic Syndrome | NAFLD | Overweight and ObesityDenmark
-
Haukeland University HospitalUniversity of BergenCompleted
-
Vårdcentralen LyckornaCompleted
-
University of NottinghamMars, Inc.Completed