Effects of High-fat and Low-fat Diet on the Gut
Primary Purpose
Metabolic Syndrome X
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
high fat diet followed by low fat diet
low fat diet followed by high fat diet
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome X
Eligibility 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
Sites / Locations
- Maastricht University, Department of Human Biology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
A
B
Arm Description
Outcomes
Primary Outcome Measures
potential early biomarkers in plasma
Secondary Outcome Measures
gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC)
gut permeability
Full Information
NCT ID
NCT00561626
First Posted
November 20, 2007
Last Updated
February 22, 2017
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00561626
Brief Title
Effects of High-fat and Low-fat Diet on the Gut
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 Type
Interventional
2. Study Status
Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome X
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
high fat diet followed by low fat diet
Intervention Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
low fat diet followed by high fat diet
Intervention Description
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 Outcome Measure Information:
Title
potential early biomarkers in plasma
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
gene expression in the small intestine and in peripheral blood mononuclear cells (PBMC)
Time Frame
3 weken
Title
gut permeability
Time Frame
4 weeks
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P. Mensink, Prof. Dr. Ir.
Organizational Affiliation
Maastricht University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University, Department of Human Biology
City
Maastricht
ZIP/Postal Code
6229 ER
Country
Netherlands
12. IPD Sharing Statement
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Effects of High-fat and Low-fat Diet on the Gut
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