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

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ClinicalTrials.gov Identifier: NCT01427140
Recruitment Status : Completed
First Posted : September 1, 2011
Last Update Posted : December 9, 2011
Sponsor:
Information provided by (Responsible Party):
Uppsala University

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Other: Polyunsaturated fatty acid group Other: Saturated fatty acid group Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : September 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Hepatic steatosis by magnetic resonance tomography (MRT) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. high density lipoprotein (HDL) [ Time Frame: 6 weeks ]
  2. low density lipoprotein (LDL) [ Time Frame: 6 weeks ]
  3. Insulin [ Time Frame: 6 weeks ]
  4. Glucose [ Time Frame: 6 weeks ]
  5. Triglycerides [ Time Frame: 6 weeks ]
  6. Cholesterol [ Time Frame: 6 weeks ]
  7. Apolipoprotein B (ApoB) [ Time Frame: 6 weeks ]
  8. Apolipoprotein A1 (ApoA1) [ Time Frame: 6 weeks ]
  9. Aspartate aminotransferase (ASAT) [ Time Frame: 6 weeks ]
  10. Alanine aminotransferase (ALAT) [ Time Frame: 6 weeks ]
  11. Gamma glutamyl transpeptidase (GGT) [ Time Frame: 6 weeks ]
  12. Homeostasis model of assessment insulin resistance (HOMA-IR) [ Time Frame: 6 weeks ]
  13. C-reactive protein (CRP) [ Time Frame: 6 weeks ]
  14. Proinsulin [ Time Frame: 6 weeks ]
  15. Endostatin [ Time Frame: 6 weeks ]
  16. Pentraxin-3 (PTX-3) [ Time Frame: 6 weeks ]
  17. Endothelin-1 (ET-1) [ Time Frame: 6 weeks ]
  18. E-selectin [ Time Frame: 6 weeks ]
  19. Cathepsin-S [ Time Frame: 6 weeks ]
  20. Cystatin C [ Time Frame: 6 weeks ]


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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT01427140     History of Changes
Other Study ID Numbers: SLS-2011-LPG
First Posted: September 1, 2011    Key Record Dates
Last Update Posted: December 9, 2011
Last Verified: December 2011

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