Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity

Not Applicable

Completed

• Conditions: Obesity; Body Fat; Insulin Resistance
• Interventions: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid

• Registration Number: NCT01138774
• Lead Sponsor: Clinica Universidad de Navarra, Universidad de Navarra

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 as well as on adipose tissue gene profile in healthy overweight/obese subjects following an energy-restricted diet.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-05-21
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Primary Completion: 2011-12
• Status Verified: 2012-02
• Study Completion: 2012-12
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 103

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Double blind dietary intervention with EPA and lipoic acid	Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements
EPA group	Double blind dietary intervention with EPA and lipoic acid	Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + EPA (1.3 g/day, 3 capsules of 433 mg/day) supplement (EPA Group).
Lipoic acid group	Double blind dietary intervention with EPA and lipoic acid	Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + LA (300 mg/day, 3 capsules of 100 mg/day) supplement (LA Group)
EPA+LA group	Double blind dietary intervention with EPA and lipoic acid	Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + EPA/LA (1.3 g /day and 300 mg/day respectively).

Primary Outcome Measures

Name	Time	Method
Weight Loss	Week 10 (end of treatment)	Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Body composition and Anthropometric parameters	Week 0 (Baseline)	Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
Body composition and anthropometric parameters	Week 10 (end of treatment)	Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
Glucose metabolism parameters	Week 10 (end of treatment)	Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
Lipid metabolism biomarkers	Week 10 (end of treatment)	Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.

Secondary Outcome Measures

Name	Time	Method
Blood Pressure and Cardiovascular Risk biomarkers	Week 10 (end of treatment)	Blood pressure, PAI-1 and VEGF will be measured.
Energy expenditure	Week 10 (end of treatment)	Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
Satiety	Week 10 (end of treatment)	Satiety will be estimated by using a VAS questionnaire
Serum inflammation biomarkers	Week 10 (end of treatment)	TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
Serum oxidative stress biomarkers	Week 10 (end of treatment)	Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
Adipose tissue gene profile and function analysis	Week 10 (end of treatment)	A biopsy (2 g) of subcutaneous abdominal periumbilical area adipose tissue will be obtained. In order to identify clusters/pathways of genes regulated by the supplementation of EPA and LA, microarray gene profiling will be performed in adipose tissue from the 4 groups after the nutritional intervention. If possible primary explant culture of adipose tissue biopsies will be also carried out.
Metabolomic and lipidomic profile	Week 10 (end of treatment)	Samples of plasma and 24-h urine will be analysed by Ultra Performance Liquid Chromatography-Mass Spectrometry (UPLC-MS), and Nuclear Magnetic Resonance (NMR), and Bidimensional Gas Chromatography-Mass Spectrometry (BC-MS).

Trial Locations

Locations (1)

Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra; 🇪🇸 Pamplona, Navarra, Spain