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Trial record 1 of 1 for:    NCT01138774
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Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity (OBEPALIP)

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ClinicalTrials.gov Identifier: NCT01138774
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra

Study Description
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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.

Condition or disease Intervention/treatment Phase
Obesity Body Fat Insulin Resistance Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cellular and Molecular Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) on Adipose Tissue: Potential Application in Human Obesity
Study Start Date : January 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Control group
Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements
 Dietary Supplement: Double 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).
Experimental: EPA group
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).
 Dietary Supplement: Double 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).
Experimental: Lipoic acid group
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)
 Dietary Supplement: Double 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).
Experimental: EPA+LA group
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).
 Dietary Supplement: Double 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).


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01138774


Locations
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Spain
Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Investigators
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Principal Investigator: Maria J Moreno-Aliaga, PhD University of Navarra
Study Director: Alfredo Martínez, PhD University of Navarra
Study Chair: Santiago Navas-Carretero, PhD University of Navarra
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01138774    
Other Study ID Numbers: OBEPALIP
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: February 2012
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
Obesity
Calorie restriction
Eicosapentaenoic acid (EPA)
Lipoic acid
Weight loss
Insulin sensitivity
 Lipid metabolism
Adipokines
Inflammation
Oxidative stress
Adipose tissue gene profile
Metabolomic profile
Additional relevant MeSH terms:
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Obesity
Insulin Resistance
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients