Obesity Clinical Trial
— LIPOGAIN-2Official title:
Role of Fatty Acids in Skeletal Muscle Hypertrophy and Ectopic Fat Accumulation During Overfeeding (LIPOGAIN-2)
Verified date | October 2016 |
Source | Uppsala University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Regional Ethical Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 60 |
Est. completion date | June 2015 |
Est. primary completion date | June 2015 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 30 Years to 50 Years |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Sweden | Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences | Uppsala | Please Select |
Lead Sponsor | Collaborator |
---|---|
Uppsala University | Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Circulating hormones and molecular analyses in muscle and fat tissue | 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 | No |
Primary | Change in lean tissue mass | Assessed by magnetic resonance imaging (MRI) and air displacement plethysmography (BodPod) | 10 weeks | No |
Secondary | Change in hepatic fat content | Assessed by magnetic resonance imaging (MRI) | 10 weeks | No |
Secondary | Change in visceral adipose tissue (VAT) | Assessed by magnetic resonance imaging (MRI) | 10 weeks | No |
Secondary | Change in total adipose tissue | Assessed by magnetic resonance imaging (MRI) | 10 weeks | No |
Secondary | Change in pancreatic fat | Assessed by MRI | 10 weeks | No |
Secondary | Change in insulin sensitivity | Assessed by oral glucose tolerance test (OGTT) | 10 weeks | No |
Secondary | Change in plasma lipids | 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 | No |
Secondary | Change in circulating inflammation and coagulation markers | Plasma tumor necrosis factor-receptor 2, Interleukin receptor 1 antagonist, C-reactive protein, fibrinogen, adhesion molecules | 10 weeks | No |
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