Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN)

Study Overview
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Brief Summary
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The purpose of this study is to investigate the metabolic consequences of a moderate weight gain and if the type of dietary fat (saturated versus polyunsaturated) can modify the effects in young healthy adults. Hypothesis: the type of dietary fat can modify the effects of weight gain.

Detailed Description
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Specific goals: Investigate if dietary fat composition influences liver fat accumulation and metabolic risk factors in response to moderate weight gain Investigate if polyunsaturated fat (PUFA) in the diet could counteract any unfavorable metabolic changes that are expected to accompany moderate weight gain Investigate effects of weight gain and dietary fat composition on markers of vascular health

Official Title
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Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study

Conditions
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Healthy

Intervention / Treatment
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* Other: Polyunsaturated fatty acid group
* Other: Saturated fatty acid group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, Body Mass Index 18-27 Exclusion Criteria: Liver disease, Coronary heart disease, Diabetes mellitus, Malignant diseases, Alcohol or drug abuse, Magnetic Resonance-incompatibility, Abnormal clinical chemistry, Use of drugs that significantly effects energy metabolism, Heavy exercise, Pregnancy or lactation, Allergy of gluten, egg or milk protein

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Saturated fatty acid group<br>Addition of saturated fatty acids to the diet inte the form of pastries | Other: Saturated fatty acid group<br>* Addition of saturated fatty acids to the diet in the form of pastries<br>|
| Active Comparator: Polyunsaturated fatty acid group<br>Addition of polyunsaturated fatty acids to the diet in the form of pastries | Other: Polyunsaturated fatty acid group<br>* Addition of polyunsaturated fatty acids to the diet in the form of pastries<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic steatosis by magnetic resonance tomography (MRT) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| high density lipoprotein (HDL) |  | 6 weeks | 
| low density lipoprotein (LDL) |  | 6 weeks | 
| Insulin |  | 6 weeks | 
| Glucose |  | 6 weeks | 
| Triglycerides |  | 6 weeks | 
| Cholesterol |  | 6 weeks | 
| Apolipoprotein B (ApoB) |  | 6 weeks | 
| Apolipoprotein A1 (ApoA1) |  | 6 weeks | 
| Aspartate aminotransferase (ASAT) |  | 6 weeks | 
| Alanine aminotransferase (ALAT) |  | 6 weeks | 
| Gamma glutamyl transpeptidase (GGT) |  | 6 weeks | 
| Homeostasis model of assessment insulin resistance (HOMA-IR) |  | 6 weeks | 
| C-reactive protein (CRP) |  | 6 weeks | 
| Proinsulin |  | 6 weeks | 
| Endostatin |  | 6 weeks | 
| Pentraxin-3 (PTX-3) |  | 6 weeks | 
| Endothelin-1 (ET-1) |  | 6 weeks | 
| E-selectin |  | 6 weeks | 
| Cathepsin-S |  | 6 weeks | 
| Cystatin C |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver fat, Polyunsaturated fatty acids (PUFA), Saturated fatty acids (SFA), Weight gain, Overfeed, Dietary fatty acids, Palm oil, Sunflower oil