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

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Basic Science
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: December 2011

Detailed Description

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

Interventions

  • Other: Polyunsaturated fatty acid group
    • Addition of polyunsaturated fatty acids to the diet in the form of pastries
  • Other: Saturated fatty acid group
    • Addition of saturated fatty acids to the diet in the form of pastries

Arms, Groups and Cohorts

  • Active Comparator: Saturated fatty acid group
    • Addition of saturated fatty acids to the diet inte the form of pastries
  • Active Comparator: Polyunsaturated fatty acid group
    • Addition of polyunsaturated fatty acids to the diet in the form of pastries

Clinical Trial Outcome Measures

Primary Measures

  • Hepatic steatosis by magnetic resonance tomography (MRT)
    • Time Frame: 6 weeks

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 38 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Uppsala University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Ulf Risérus, Ass. professor, Principal Investigator, Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University

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