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

Metabolic Syndrome X Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561626
• Other study ID #: 07-3-088
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: February 22, 2017
• Start date: January 2008
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome X

Intervention

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
• 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

Locations

Country	Name	City	State
Netherlands	Maastricht University, Department of Human Biology	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	potential early biomarkers in plasma		3 weeks
Secondary	gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC)		3 weken
Secondary	gut permeability		4 weeks