Status:
COMPLETED
Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Obesity
Body Fat
Eligibility:
FEMALE
20-45 years
Phase:
NA
Brief Summary
The aim of the study is to analyze the effects of Lipoic acid and/or EPA supplementation on weight loss, lipid profile, insulin resistance, oxidative and inflammation parameters, metabolomic profile a...
Eligibility Criteria
Inclusion
- Women
- Ages between 20 and 45 years, and with regular menstrual cycles
- Body Mass Index (BMI) between 27.5 and 39.9 kg/m2
- Weight unchanged (± 3 kg) for the last 3 months
- All subjects should have an overall physical and psychological condition that the investigator believes is in accordance with the overall aim of the study.
Exclusion
- Use of prescription medication
- To suffer from any chronic metabolic or obesity related disease, hepatic or renal systemic disease: Hypertension, dislipidemia, type 1 or 2 diabetes, thyroid function disorders, cirrhosis, fatty liver, etc.
- Food allergies or food intolerance expected to come up during the study
- Special diets (Atkins, vegetarian, etc.) prior three months the start of the study.
- Eating disorders
- Surgically treated obesity
- Pregnant or lactating women or planning to be pregnant in the next two months
- Alcohol or drug abuse (based on clinical parameters)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT01138774
Start Date
January 1 2010
End Date
December 1 2012
Last Update
May 28 2015
Active Locations (1)
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1
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarre, Spain, 31008