Body Fat, Insulin Resistance, Obesity
Conditions
Keywords
Obesity, Calorie restriction, Eicosapentaenoic acid (EPA), Lipoic acid, Weight loss, Insulin sensitivity, Lipid metabolism, Adipokines, Inflammation, Oxidative stress, Adipose tissue gene profile, Metabolomic profile
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.
Interventions
DIETARY_SUPPLEMENTDouble blind dietary intervention with EPA and lipoic acid
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).
Sponsors
Clinica Universidad de Navarra, Universidad de Navarra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight Loss | Week 0 (baseline) | 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 0 (baseline) | Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index |
| Lipid metabolism biomarkers | Week 0 (baseline) | Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Blood Pressure and Cardiovascular Risk biomarkers | Baseline | Blood pressure, PAI-1 and VEGF will be measured. |
| Metabolomic and lipidomic profile | Baseline | 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). |
| Energy expenditure | Baseline | Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits |
| Satiety | Baseline | Satiety will be estimated by using a VAS questionnaire |
| Serum inflammation biomarkers | Baseline | TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin |
| Serum oxidative stress biomarkers | Baseline | Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD). |
Countries
Spain
Outcome results
None listed