Effects of High-fat and Low-fat Diet on the Gut
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|ClinicalTrials.gov Identifier: NCT00561626|
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : February 24, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome X||Dietary Supplement: high fat diet followed by low fat diet Dietary Supplement: low fat diet followed by high fat diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||October 2008|
|Actual Study Completion Date :||December 2008|
Dietary Supplement: high fat diet followed by low fat diet
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
Dietary Supplement: low fat diet followed by high fat diet
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
- potential early biomarkers in plasma [ Time Frame: 3 weeks ]
- gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC) [ Time Frame: 3 weken ]
- gut permeability [ Time Frame: 4 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561626
|Maastricht University, Department of Human Biology|
|Maastricht, Netherlands, 6229 ER|
|Principal Investigator:||Ronald P. Mensink, Prof. Dr. Ir.||Maastricht University|