Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation (LIPOGAIN-2)

October 25, 2016 updated by: David Iggman, Uppsala University

Role of Fatty Acids in Skeletal Muscle Hypertrophy and Ectopic Fat Accumulation During Overfeeding (LIPOGAIN-2)

To investigate metabolic and molecular response to fatty acid-specific overfeeding in overweight subjects, in relation to changes in ectopic fat, lean tissue mass and insulin sensitivity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Please Select
      • Uppsala, Please Select, Sweden, 75185
        • Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index 25-32

Exclusion Criteria:

  • Type 2 diabetes
  • Type 1 diabetes
  • Kidney disease
  • Liver disease
  • Abnormal clinical chemistry at screening
  • Intense physical exercise > 2 hours per week
  • Use of statins or drugs affecting energy metabolism
  • Use of extreme diets

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Saturated fatty acids (SFA)-group
Weight gain created by addition of muffins baked on saturated fat
Dietary supplement: SFA-group
Experimental: Polyunsaturated fatty acids (PUFA)-group
Weight gain created by addition of muffins baked on polyunsaturated fat
Dietary supplement: PUFA-group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lean tissue mass
Time Frame: 10 weeks
Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hepatic fat content
Time Frame: 10 weeks
Assessed by magnetic resonance imaging (MRI)
10 weeks
Change in visceral adipose tissue (VAT)
Time Frame: 10 weeks
Assessed by magnetic resonance imaging (MRI)
10 weeks
Change in total adipose tissue
Time Frame: 10 weeks
Assessed by magnetic resonance imaging (MRI)
10 weeks
Change in pancreatic fat
Time Frame: 10 weeks
Assessed by MRI
10 weeks
Change in insulin sensitivity
Time Frame: 10 weeks
Assessed by oral glucose tolerance test (OGTT)
10 weeks
Change in plasma lipids
Time Frame: 10 weeks
Plasma cholesterol, low-density lipoprotein, high-density lipoprotein, triglycerides, apolipoprotein B, apolipoprotein A1, free fatty acids, glycerol, proprotein convertase subtilisin/kexin type 9
10 weeks
Change in circulating inflammation and coagulation markers
Time Frame: 10 weeks
Plasma tumor necrosis factor-receptor 2, Interleukin receptor 1 antagonist, C-reactive protein, fibrinogen, adhesion molecules
10 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Circulating hormones and molecular analyses in muscle and fat tissue
Time Frame: 10 weeks
Serum hormones including prolactin, tyroxin, T3, cortisol, growth hormone, Insulin growth factor-1. Fat cell morphology assessment in fat tissue, and gene and protein expression, DNA methylation analyses in fat and muscle tissue, palmitate tracer uptake in liver using positron emission tomography
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Ulf Riserus, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2014

Primary Completion (Actual)

June 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

August 6, 2014

First Submitted That Met QC Criteria

August 6, 2014

First Posted (Estimate)

August 7, 2014

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 25, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIPOGAIN-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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