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OpenTrials
Completed

NCT Number: NCT02211612

Overeating Different Fats and Influence on Muscle Mass and Body Fat Accumulation

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

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Key information

Conditions

Obesity Body Composition Body Weight Body Weight Changes Digestive System Diseases Ectopic Fat Fatty Liver Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Liver Diseases Metabolic Diseases Muscle Mass Nutrition Disorders Nutritional and Metabolic Diseases Overfeeding Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Gain

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences

Uppsala, Please Select, 75185, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PUFA-group

Dietary Supplement

SFA-group

Dietary Supplement

Primary outcomes

  1. Change in lean tissue mass

    Time frame: 10 weeks

    Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod)

Secondary outcomes

  1. Change in hepatic fat content

    Time frame: 10 weeks

    Assessed by magnetic resonance imaging (MRI)

  2. Change in visceral adipose tissue (VAT)

    Time frame: 10 weeks

    Assessed by magnetic resonance imaging (MRI)

  3. Change in total adipose tissue

    Time frame: 10 weeks

    Assessed by magnetic resonance imaging (MRI)

  4. Change in pancreatic fat

    Time frame: 10 weeks

    Assessed by MRI

  5. Change in insulin sensitivity

    Time frame: 10 weeks

    Assessed by oral glucose tolerance test (OGTT)

  6. 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

  7. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska Institutet

Registry information

Official study title

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

Acronym: LIPOGAIN-2

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Aug 7, 2014
Registry last updated
Oct 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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