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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 25, 2014