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

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Polyunsaturated fatty acid group
Saturated fatty acid group
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Liver fat, Polyunsaturated fatty acids (PUFA), Saturated fatty acids (SFA), Weight gain, Overfeed, Dietary fatty acids, Palm oil, Sunflower oil

Eligibility Criteria

20 Years - 38 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Uppsala University Hospital, Uppsala Science Park

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Saturated fatty acid group

Polyunsaturated fatty acid group

Arm Description

Addition of saturated fatty acids to the diet inte the form of pastries

Addition of polyunsaturated fatty acids to the diet in the form of pastries

Outcomes

Primary Outcome Measures

Hepatic steatosis by magnetic resonance tomography (MRT)

Secondary Outcome Measures

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

Full Information

First Posted
August 19, 2011
Last Updated
December 8, 2011
Sponsor
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01427140
Brief Title
Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN)
Acronym
LIPOGAIN
Official Title
Metabolic Consequences of Moderate Weight Gain - Role of Dietary Fat Composition (LIPOGAIN): a Randomized Double-Blind Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Liver fat, Polyunsaturated fatty acids (PUFA), Saturated fatty acids (SFA), Weight gain, Overfeed, Dietary fatty acids, Palm oil, Sunflower oil

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Saturated fatty acid group
Arm Type
Active Comparator
Arm Description
Addition of saturated fatty acids to the diet inte the form of pastries
Arm Title
Polyunsaturated fatty acid group
Arm Type
Active Comparator
Arm Description
Addition of polyunsaturated fatty acids to the diet in the form of pastries
Intervention Type
Other
Intervention Name(s)
Polyunsaturated fatty acid group
Intervention Description
Addition of polyunsaturated fatty acids to the diet in the form of pastries
Intervention Type
Other
Intervention Name(s)
Saturated fatty acid group
Intervention Description
Addition of saturated fatty acids to the diet in the form of pastries
Primary Outcome Measure Information:
Title
Hepatic steatosis by magnetic resonance tomography (MRT)
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
high density lipoprotein (HDL)
Time Frame
6 weeks
Title
low density lipoprotein (LDL)
Time Frame
6 weeks
Title
Insulin
Time Frame
6 weeks
Title
Glucose
Time Frame
6 weeks
Title
Triglycerides
Time Frame
6 weeks
Title
Cholesterol
Time Frame
6 weeks
Title
Apolipoprotein B (ApoB)
Time Frame
6 weeks
Title
Apolipoprotein A1 (ApoA1)
Time Frame
6 weeks
Title
Aspartate aminotransferase (ASAT)
Time Frame
6 weeks
Title
Alanine aminotransferase (ALAT)
Time Frame
6 weeks
Title
Gamma glutamyl transpeptidase (GGT)
Time Frame
6 weeks
Title
Homeostasis model of assessment insulin resistance (HOMA-IR)
Time Frame
6 weeks
Title
C-reactive protein (CRP)
Time Frame
6 weeks
Title
Proinsulin
Time Frame
6 weeks
Title
Endostatin
Time Frame
6 weeks
Title
Pentraxin-3 (PTX-3)
Time Frame
6 weeks
Title
Endothelin-1 (ET-1)
Time Frame
6 weeks
Title
E-selectin
Time Frame
6 weeks
Title
Cathepsin-S
Time Frame
6 weeks
Title
Cystatin C
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
38 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ulf Risérus, Ass. professor
Organizational Affiliation
Clinical Nutrition and Metabolism, Dept. of Public Health and Caring Sciences, Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala University Hospital, Uppsala Science Park
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
33344496
Citation
Rosqvist F, Orho-Melander M, Kullberg J, Iggman D, Johansson HE, Cedernaes J, Ahlstrom H, Riserus U. Abdominal Fat and Metabolic Health Markers but Not PNPLA3 Genotype Predicts Liver Fat Accumulation in Response to Excess Intake of Energy and Saturated Fat in Healthy Individuals. Front Nutr. 2020 Dec 3;7:606004. doi: 10.3389/fnut.2020.606004. eCollection 2020.
Results Reference
derived
PubMed Identifier
28275132
Citation
Perfilyev A, Dahlman I, Gillberg L, Rosqvist F, Iggman D, Volkov P, Nilsson E, Riserus U, Ling C. Impact of polyunsaturated and saturated fat overfeeding on the DNA-methylation pattern in human adipose tissue: a randomized controlled trial. Am J Clin Nutr. 2017 Apr;105(4):991-1000. doi: 10.3945/ajcn.116.143164. Epub 2017 Mar 8. Erratum In: Am J Clin Nutr. 2017 Jul;106(1):325.
Results Reference
derived
PubMed Identifier
25319187
Citation
Iggman D, Rosqvist F, Larsson A, Arnlov J, Beckman L, Rudling M, Riserus U. Role of dietary fats in modulating cardiometabolic risk during moderate weight gain: a randomized double-blind overfeeding trial (LIPOGAIN study). J Am Heart Assoc. 2014 Oct 15;3(5):e001095. doi: 10.1161/JAHA.114.001095.
Results Reference
derived

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

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