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

This study has been completed.
Sponsor:
Information provided by:
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00561626
First received: November 20, 2007
Last updated: December 11, 2008
Last verified: December 2008
History of Changes
  Purpose

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 Intervention
Metabolic Syndrome X
 Dietary Supplement: high fat diet followed by low fat diet
Dietary Supplement: low fat diet followed by high fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • potential early biomarkers in plasma [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC) [ Time Frame: 3 weken ] [ Designated as safety issue: No ]
  • gut permeability [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A 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
Experimental: B 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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561626

Locations
Netherlands
Maastricht University, Department of Human Biology
Maastricht, Netherlands, 6229 ER
Sponsors and Collaborators
Maastricht University Medical Center
Investigators
Principal Investigator: Ronald P. Mensink, Prof. Dr. Ir. Maastricht University
  More Information

No publications provided

Responsible Party: Ronald P. Mensink, Prof. Dr. Ir., Maastricht University
ClinicalTrials.gov Identifier: NCT00561626     History of Changes
Other Study ID Numbers: 07-3-088
Study First Received: November 20, 2007
Last Updated: December 11, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 23, 2013