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Completed

NCT Number: NCT01138774

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

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.

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Key information

Conditions

Obesity Body Fat Body Weight Body Weight Changes Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Pamplona, Navarre, 31008, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Double blind dietary intervention with EPA and lipoic acid

Dietary 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).

Primary outcomes

  1. Weight Loss

    Time frame: 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.

  2. Weight Loss

    Time frame: Week 2

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

  3. Weight Loss

    Time frame: Week 4

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

  4. Weight Loss

    Time frame: week 6

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

  5. Weight Loss

    Time frame: Week 8

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

  6. Weight Loss

    Time frame: 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.

  7. Body composition and Anthropometric parameters

    Time frame: 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.

  8. Body composition and anthropometric parameters

    Time frame: 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.

  9. Glucose metabolism parameters

    Time frame: Week 0 (baseline)

    Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index

  10. Glucose metabolism parameters

    Time frame: Week 10 (end of treatment)

    Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index

  11. Lipid metabolism biomarkers

    Time frame: Week 0 (baseline)

    Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.

  12. Lipid metabolism biomarkers

    Time frame: Week 10 (end of treatment)

    Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.

Secondary outcomes

  1. Blood Pressure and Cardiovascular Risk biomarkers

    Time frame: Baseline

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

  2. Blood Pressure and Cardiovascular Risk biomarkers

    Time frame: Week 10 (end of treatment)

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

  3. Energy expenditure

    Time frame: Baseline

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

  4. Energy expenditure

    Time frame: 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

  5. Satiety

    Time frame: Baseline

    Satiety will be estimated by using a VAS questionnaire

  6. Satiety

    Time frame: Week 10 (end of treatment)

    Satiety will be estimated by using a VAS questionnaire

  7. Serum inflammation biomarkers

    Time frame: Baseline

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

  8. Serum inflammation biomarkers

    Time frame: Week 10 (end of treatment)

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

  9. Serum oxidative stress biomarkers

    Time frame: Baseline

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

  10. Serum oxidative stress biomarkers

    Time frame: Week 10 (end of treatment)

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

  11. Adipose tissue gene profile and function analysis

    Time frame: 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.

  12. Metabolomic and lipidomic profile

    Time frame: 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).

  13. Metabolomic and lipidomic profile

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study title

Cellular and Molecular Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) on Adipose Tissue: Potential Application in Human Obesity

Acronym: OBEPALIP

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Jun 7, 2010
Registry last updated
May 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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