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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uppsala University
ClinicalTrials.gov Identifier:
NCT01427140
First received: August 19, 2011
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention
Healthy
 Other: Polyunsaturated fatty acid group
Other: Saturated fatty acid group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Hepatic steatosis by magnetic resonance tomography (MRT) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • high density lipoprotein (HDL) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • low density lipoprotein (LDL) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Insulin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Glucose [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Cholesterol [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein B (ApoB) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Apolipoprotein A1 (ApoA1) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Aspartate aminotransferase (ASAT) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Alanine aminotransferase (ALAT) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Gamma glutamyl transpeptidase (GGT) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Homeostasis model of assessment insulin resistance (HOMA-IR) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • C-reactive protein (CRP) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Proinsulin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Endostatin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Pentraxin-3 (PTX-3) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Endothelin-1 (ET-1) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • E-selectin [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Cathepsin-S [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Cystatin C [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Enrollment: 41
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Saturated fatty acid group
Addition of saturated fatty acids to the diet inte the form of pastries
 Other: Saturated fatty acid group
Addition of saturated fatty acids to the diet in the form of pastries
Active Comparator: Polyunsaturated fatty acid group
Addition of polyunsaturated fatty acids to the diet in the form of pastries
 Other: Polyunsaturated fatty acid group
Addition of polyunsaturated fatty acids to the diet in the form of pastries

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
  Eligibility

Ages Eligible for Study:   20 Years to 38 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427140

Locations
Sweden
Uppsala University Hospital, Uppsala Science Park
Uppsala, Sweden
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Ulf Risérus, Ass. professor Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
  More Information

No publications provided

Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01427140     History of Changes
Other Study ID Numbers: SLS-2011-LPG
Study First Received: August 19, 2011
Last Updated: December 8, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University:
Liver fat
Polyunsaturated fatty acids (PUFA)
Saturated fatty acids (SFA)
Weight gain
 Overfeed
Dietary fatty acids
Palm oil
Sunflower oil

Additional relevant MeSH terms:
Weight Gain
Body Weight Changes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013