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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02211612
Other study ID # LIPOGAIN-2
Secondary ID
Status Completed
Phase N/A
First received August 6, 2014
Last updated October 25, 2016
Start date September 2014
Est. completion date June 2015

Study information

Verified date October 2016
Source Uppsala University
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
PUFA-group

SFA-group


Locations

Country Name City State
Sweden Uppsala University; Clinical nutrition and metabolism; Dept of public health and caring sciences Uppsala Please Select

Sponsors (2)

Lead Sponsor Collaborator
Uppsala University Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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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