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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

Tracking Information
First Submitted Date  ICMJE May 21, 2010
First Posted Date  ICMJE June 7, 2010
Last Update Posted Date May 28, 2015
Study Start Date  ICMJE January 2010
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Glucose metabolism parameters [ Time Frame: Week 0 (baseline) ]
    Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
  • Glucose metabolism parameters [ Time Frame: Week 10 (end of treatment) ]
    Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
  • Lipid metabolism biomarkers [ Time Frame: Week 0 (baseline) ]
    Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
  • Lipid metabolism biomarkers [ Time Frame: Week 10 (end of treatment) ]
    Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01138774 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 4, 2010)
  • Blood Pressure and Cardiovascular Risk biomarkers [ Time Frame: Baseline ]
    Blood pressure, PAI-1 and VEGF will be measured.
  • Blood Pressure and Cardiovascular Risk biomarkers [ Time Frame: Week 10 (end of treatment) ]
    Blood pressure, PAI-1 and VEGF will be measured.
  • 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
  • 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
  • Satiety [ Time Frame: Baseline ]
    Satiety will be estimated by using a VAS questionnaire
  • Satiety [ Time Frame: Week 10 (end of treatment) ]
    Satiety will be estimated by using a VAS questionnaire
  • Serum inflammation biomarkers [ Time Frame: Baseline ]
    TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
  • Serum inflammation biomarkers [ Time Frame: Week 10 (end of treatment) ]
    TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
  • Serum oxidative stress biomarkers [ Time Frame: Baseline ]
    Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
  • Serum oxidative stress biomarkers [ Time Frame: Week 10 (end of treatment) ]
    Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
  • 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.
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity
Official Title  ICMJE Cellular and Molecular Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) on Adipose Tissue: Potential Application in Human Obesity
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Body Fat
  • Insulin Resistance
Intervention  ICMJE 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).
Study Arms  ICMJE
  • Placebo Comparator: Control group
    Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements
    Intervention: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid
  • 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).
    Intervention: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid
  • 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)
    Intervention: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid
  • 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).
    Intervention: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 27, 2015)
103
Original Estimated Enrollment  ICMJE
 (submitted: June 4, 2010)
80
Actual Study Completion Date  ICMJE December 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 20 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01138774
Other Study ID Numbers  ICMJE OBEPALIP
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Clinica Universidad de Navarra, Universidad de Navarra
Study Sponsor  ICMJE Clinica Universidad de Navarra, Universidad de Navarra
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Clinica Universidad de Navarra, Universidad de Navarra
Verification Date February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP