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NCT Number: NCT00561626

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

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.

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Key information

Conditions

Metabolic Syndrome X Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University, Department of Human Biology

Maastricht, 6229 ER, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high fat diet followed by low fat diet

Dietary 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 diet

Dietary 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

Primary outcomes

  1. potential early biomarkers in plasma

    Time frame: 3 weeks

Secondary outcomes

  1. gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC)

    Time frame: 3 weken

  2. gut permeability

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Nov 21, 2007
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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