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

Clinica Universidad de Navarra, Universidad de Navarra103 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

103

Conditions

Obesity Body Fat Insulin Resistance

Interventions

Double blind dietary intervention with EPA and lipoic acidDIETARY_SUPPLEMENT

Placebo-controlled dietary intervention during 10 weeks. All groups will have a dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline, supplemented with eicosapentaenoic acid (EPA) and/or lipoic acid (LA).

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

Pamplona, Navarre, Spain

Outcomes

Primary Outcomes

Weight Loss

Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.

Time frame: Week 0 (baseline)

Weight Loss

Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.

Time frame: Week 2

Weight Loss

Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.

Time frame: Week 4

Weight Loss

Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.

Time frame: week 6

Weight Loss

Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.

Time frame: Week 8

Weight Loss

Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.

Time frame: Week 10 (end of treatment)

Body composition and Anthropometric parameters

Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.

Time frame: Week 0 (Baseline)

Body composition and anthropometric parameters

Data from ClinicalTrials.gov

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Secondary Outcomes

Blood Pressure and Cardiovascular Risk biomarkers

Blood pressure, PAI-1 and VEGF will be measured.

Time frame: Baseline

Blood Pressure and Cardiovascular Risk biomarkers

Blood pressure, PAI-1 and VEGF will be measured.

Time frame: Week 10 (end of treatment)

Energy expenditure

Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits

Time frame: Baseline

Energy expenditure

Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits

Time frame: Week 10 (end of treatment)

Satiety

Satiety will be estimated by using a VAS questionnaire

Time frame: Baseline

Satiety

Satiety will be estimated by using a VAS questionnaire

Time frame: Week 10 (end of treatment)

Serum inflammation biomarkers

TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin

Time frame: Baseline

Serum inflammation biomarkers

TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin

Time frame: Week 10 (end of treatment)

Serum oxidative stress biomarkers

Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).

Time frame: Baseline

Serum oxidative stress biomarkers

Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).

Time frame: Week 10 (end of treatment)

Adipose tissue gene profile and function analysis

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.

Time frame: Week 10 (end of treatment)

Metabolomic and lipidomic profile

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).

Time frame: Baseline

Metabolomic and lipidomic profile

Time frame: Week 10 (end of treatment)