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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Clinica Universidad de Navarra, Universidad de Navarra.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01138774
First received: May 21, 2010
Last updated: February 28, 2012
Last verified: February 2012
  Purpose

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 Intervention
Obesity
Body Fat
Insulin Resistance
Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: Week 0 (baseline) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index

  • Glucose metabolism parameters [ Time Frame: Week 10 (end of treatment) ] [ Designated as safety issue: No ]
    Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index

  • Lipid metabolism biomarkers [ Time Frame: Week 0 (baseline) ] [ Designated as safety issue: No ]
    Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.

  • Lipid metabolism biomarkers [ Time Frame: Week 10 (end of treatment) ] [ Designated as safety issue: No ]
    Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.


Secondary Outcome Measures:
  • Blood Pressure and Cardiovascular Risk biomarkers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Blood pressure, PAI-1 and VEGF will be measured.

  • Blood Pressure and Cardiovascular Risk biomarkers [ Time Frame: Week 10 (end of treatment) ] [ Designated as safety issue: No ]
    Blood pressure, PAI-1 and VEGF will be measured.

  • Energy expenditure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits

  • Satiety [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Satiety will be estimated by using a VAS questionnaire

  • Satiety [ Time Frame: Week 10 (end of treatment) ] [ Designated as safety issue: No ]
    Satiety will be estimated by using a VAS questionnaire

  • Serum inflammation biomarkers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin

  • Serum inflammation biomarkers [ Time Frame: Week 10 (end of treatment) ] [ Designated as safety issue: No ]
    TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin

  • Serum oxidative stress biomarkers [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).

  • Serum oxidative stress biomarkers [ Time Frame: Week 10 (end of treatment) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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).


Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138774

Locations
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
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

Additional Information:
Publications:

Responsible Party: Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier: NCT01138774     History of Changes
Other Study ID Numbers: OBEPALIP
Study First Received: May 21, 2010
Last Updated: February 28, 2012
Health Authority: Spain: Ethics Committee

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:
Insulin Resistance
Obesity
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Thioctic Acid
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on August 19, 2014