Effects of High-fat & Low-fat Diet on the Gut

Status Completed

Clinical 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. 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Metabolic Syndrome X

Clinical Trial Details

NCT number	NCT00561626
Study type	Interventional
Source	Maastricht University Medical Center
Contact
Status	Completed
Phase	N/A
Start date	January 2008
Completion date	December 2008

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT02702375` - Meta-analyses of Impotrant Food Sources of Sugars and Incident Cardiometabolic Diseases	N/A
Completed	`NCT02918422` - Controlled Clinical Study to Determine Novel Health Benefits of Cheese Consumption	N/A
Completed	`NCT02649348` - Effects of Prehabilitation in Gastric Cancer Patients With Metabolic Syndrome on Perioperative Outcome	N/A
Completed	`NCT02337933` - Effect of Ursolic Acid Administration on Insulin Sensitivity and Metabolic Syndrome	Phase 2
Completed	`NCT02356952` - Effect of a Low Glycemic Index on Metabolic Syndrome	N/A
Completed	`NCT02459691` - Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos)	N/A
Completed	`NCT02402985` - Comparison of a Plant Protein Diet to a Animal Protein Diet Emphasized in Type 2 Diabetics	N/A
Completed	`NCT01694056` - Soy Protein Intake and the Metabolic Syndrome	N/A
Completed	`NCT00344903` - Dallas Heart Study 2: Return Clinic Visit for the Dallas Heart Study Cohort	N/A
Recruiting	`NCT00408824` - Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)	N/A
Completed	`NCT00362908` - Effects of Low and Moderate Fat Diets on Lipids, Inflammation and Vascular Reactivity in the Metabolic Syndrome	N/A
Completed	`NCT00395486` - ROMEO (Rosuvastatin in Metabolic syndrOme)	Phase 4
Completed	`NCT00140816` - Dairy Products and Metabolic Effects (Norwegian Part)	N/A
Completed	`NCT00166036` - Effect of Statins on Oxidative Stress and Endothelial Progenitor Cells	Phase 2
Completed	`NCT00455325` - Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS)	Phase 2
Completed	`NCT00101517` - Partnership Programs to Reduce Ethnic Differences in the Risk of Cardiovascular Disease	N/A
Recruiting	`NCT00177892` - Obstructive Sleep Apnea (OSA) and Metabolic Syndrome: Role of Oxidative Stress	N/A
Completed	`NCT00074451` - Genomewide Search for Loci Underlying Metabolic Syndrome
Completed	`NCT00073775` - Epidemiology of Stress and the Metabolic Syndrome	N/A
Completed	`NCT00200993` - Peripheral Effects of Exercise on Cardiovascular Health (STRRIDE I)	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effects of High-fat and Low-fat Diet on the Gut

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms