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

Completed

• Conditions: disturbed fat and glucose metabolism; metabolic syndrome; 10000546

• Registration Number: NL-OMON31635
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 13 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

age between 18 and 65 years
body mass index (BMI) between 18 and 30 kg/m2

Exclusion Criteria

- BMI <= 18 and >= 30 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Potential early biomarkers of the metabolic syndrome in blood and gene<br /><br>expression profiles in the small intestine.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Parameters of the metabolic syndrome in blood, gene expression profiles in PBMC<br /><br>and gut permeability.</p><br>