ObesityOBEPALIPNCT01138774

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

A study testing Double blind dietary intervention with EPA and lipoic acid in people with Obesity and Body Fat, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 20 to 45 years, women onlyHealthy volunteers can take part
Conditions the study is for: Obesity, Body Fat, Insulin Resistance
What is being tested?: Double blind dietary intervention with EPA and lipoic acid
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 1 siteSpain
Study dates: Jan 2010to Dec 2012
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 45 years
Women only
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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)

Trial locations and contacts

1 site in 1 country.

Spain1 site

Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
Pamplona, Navarre, 31008

Other trials in Spain

About this study

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

Conditions: Obesity, Body Fat, Insulin Resistance
Being tested: Double blind dietary intervention with EPA and lipoic acid
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
Medical subject headings: Obesity, Insulin Resistance, Weight Loss, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Double blind dietary intervention with EPA and lipoic acidDietary 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).

Study groups in NCT01138774
Study group	Role	What they receive
Control group	Placebo comparator	Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements Receives: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid
EPA group	Experimental	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). Receives: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid
Lipoic acid group	Experimental	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) Receives: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid
EPA+LA group	Experimental	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). Receives: Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid

What is being measured

The primary outcome is the main question the study is designed to answer.

Weight Loss
Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Measured: Week 0 (baseline)
Weight Loss
Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Measured: Week 2
Weight Loss
Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Measured: Week 4
Weight Loss
Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Measured: week 6
Weight Loss
Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Measured: Week 8
Weight Loss
Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
Measured: Week 10 (end of treatment)
Body composition and Anthropometric parameters
Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
Measured: Week 0 (Baseline)
Body composition and anthropometric parameters
Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
Measured: Week 10 (end of treatment)
Glucose metabolism parameters
Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
Measured: Week 0 (baseline)
Glucose metabolism parameters
Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
Measured: Week 10 (end of treatment)
Lipid metabolism biomarkers
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
Measured: Week 0 (baseline)
Lipid metabolism biomarkers
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
Measured: Week 10 (end of treatment)

Secondary outcomes (13)

Blood Pressure and Cardiovascular Risk biomarkers
Blood pressure, PAI-1 and VEGF will be measured.
Measured: Baseline
Blood Pressure and Cardiovascular Risk biomarkers
Blood pressure, PAI-1 and VEGF will be measured.
Measured: Week 10 (end of treatment)
Energy expenditure
Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
Measured: Baseline
Energy expenditure
Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
Measured: Week 10 (end of treatment)
Satiety
Satiety will be estimated by using a VAS questionnaire
Measured: Baseline
Satiety
Satiety will be estimated by using a VAS questionnaire
Measured: Week 10 (end of treatment)
Serum inflammation biomarkers
TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
Measured: Baseline
Serum inflammation biomarkers
TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
Measured: Week 10 (end of treatment)
Serum oxidative stress biomarkers
Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
Measured: Baseline
Serum oxidative stress biomarkers
Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
Measured: Week 10 (end of treatment)
Adipose tissue gene profile and function analysis
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.
Measured: Week 10 (end of treatment)
Metabolomic and lipidomic profile
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).
Measured: Baseline
Metabolomic and lipidomic profile
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).
Measured: Week 10 (end of treatment)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Dec 2012

First posted7 Jun 2010 (estimated)
Study startJan 2010
Primary completionDec 2011
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for ObesityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01138774
Sponsor's protocol ID: OBEPALIP
Acronym: OBEPALIP
Status last verified: Feb 2012
First submitted: 21 May 2010
Last updated: 28 May 2015
Results posted: No
Data monitoring committee: No

Publications

Prieto-Hontoria PL, Perez-Matute P, Fernandez-Galilea M, Barber A, Martinez JA, Moreno-Aliaga MJ. Lipoic acid prevents body weight gain induced by a high fat diet in rats: effects on intestinal sugar transport. J Physiol Biochem. 2009 Mar;65(1):43-50. doi: 10.1007/BF03165968.
PubMed 19588730
Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid up-regulates apelin secretion and gene expression in 3T3-L1 adipocytes. Mol Nutr Food Res. 2010 May;54 Suppl 1:S104-11. doi: 10.1002/mnfr.200900522.
PubMed 20352620
Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid stimulates AMP-activated protein kinase and increases visfatin secretion in cultured murine adipocytes. Clin Sci (Lond). 2009 Aug 14;117(6):243-9. doi: 10.1042/CS20090020.
PubMed 19296827
Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Marti A, Martinez JA, Moreno-Aliaga MJ. Down-regulation in muscle and liver lipogenic genes: EPA ethyl ester treatment in lean and overweight (high-fat-fed) rats. J Nutr Biochem. 2009 Sep;20(9):705-14. doi: 10.1016/j.jnutbio.2008.06.013. Epub 2008 Sep 30.
PubMed 18829285
Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Baena MJ, Marti A, Martinez JA, Moreno-Aliaga MJ. Differential inflammatory status in rats susceptible or resistant to diet-induced obesity: effects of EPA ethyl ester treatment. Eur J Nutr. 2008 Oct;47(7):380-6. doi: 10.1007/s00394-008-0738-3. Epub 2008 Sep 18.
PubMed 18807107
Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Martinez JA, Moreno-Aliaga MJ. Effects of eicosapentaenoic acid ethyl ester on visfatin and apelin in lean and overweight (cafeteria diet-fed) rats. Br J Nutr. 2009 Apr;101(7):1059-67. doi: 10.1017/S0007114508048307. Epub 2008 Aug 28.
PubMed 18755047
Perez-Matute P, Perez-Echarri N, Martinez JA, Marti A, Moreno-Aliaga MJ. Eicosapentaenoic acid actions on adiposity and insulin resistance in control and high-fat-fed rats: role of apoptosis, adiponectin and tumour necrosis factor-alpha. Br J Nutr. 2007 Feb;97(2):389-98. doi: 10.1017/S0007114507207627.
PubMed 17298710
Marrades MP, Martinez JA, Moreno-Aliaga MJ. Differences in short-term metabolic responses to a lipid load in lean (resistant) vs obese (susceptible) young male subjects with habitual high-fat consumption. Eur J Clin Nutr. 2007 Feb;61(2):166-74. doi: 10.1038/sj.ejcn.1602500. Epub 2006 Aug 9.
PubMed 16900083
Marrades MP, Milagro FI, Martinez JA, Moreno-Aliaga MJ. Differential expression of aquaporin 7 in adipose tissue of lean and obese high fat consumers. Biochem Biophys Res Commun. 2006 Jan 20;339(3):785-9. doi: 10.1016/j.bbrc.2005.11.080. Epub 2005 Nov 22.
PubMed 16325777
Ramel A, Martinez A, Kiely M, Morais G, Bandarra NM, Thorsdottir I. Beneficial effects of long-chain n-3 fatty acids included in an energy-restricted diet on insulin resistance in overweight and obese European young adults. Diabetologia. 2008 Jul;51(7):1261-8. doi: 10.1007/s00125-008-1035-7. Epub 2008 May 20.
PubMed 18491071
Parra D, Ramel A, Bandarra N, Kiely M, Martinez JA, Thorsdottir I. A diet rich in long chain omega-3 fatty acids modulates satiety in overweight and obese volunteers during weight loss. Appetite. 2008 Nov;51(3):676-80. doi: 10.1016/j.appet.2008.06.003. Epub 2008 Jun 14.
PubMed 18602429
Ramel A, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Moderate consumption of fatty fish reduces diastolic blood pressure in overweight and obese European young adults during energy restriction. Nutrition. 2010 Feb;26(2):168-74. doi: 10.1016/j.nut.2009.04.002. Epub 2009 May 31.
PubMed 19487105
Navas-Carretero S, Perez-Granados AM, Schoppen S, Vaquero MP. An oily fish diet increases insulin sensitivity compared to a red meat diet in young iron-deficient women. Br J Nutr. 2009 Aug;102(4):546-53. doi: 10.1017/S0007114509220794. Epub 2009 Feb 12.
PubMed 19210857
Romo-Hualde A, Huerta AE, Gonzalez-Navarro CJ, Ramos-Lopez O, Moreno-Aliaga MJ, Martinez JA. Untargeted metabolomic on urine samples after alpha-lipoic acid and/or eicosapentaenoic acid supplementation in healthy overweight/obese women. Lipids Health Dis. 2018 May 9;17(1):103. doi: 10.1186/s12944-018-0750-4.
PubMed 29743087
Huerta AE, Prieto-Hontoria PL, Sainz N, Martinez JA, Moreno-Aliaga MJ. Supplementation with alpha-Lipoic Acid Alone or in Combination with Eicosapentaenoic Acid Modulates the Inflammatory Status of Healthy Overweight or Obese Women Consuming an Energy-Restricted Diet. J Nutr. 2015 Apr 1;146(4):889S-896S. doi: 10.3945/jn.115.224105.
PubMed 26962183

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cellular and Molecular Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) on Adipose Tissue: Potential Application in Human Obesity
ClinicalTrials.gov ID: NCT01138774
Acronym / sponsor ID: OBEPALIP / OBEPALIP
Conditions: Obesity, Body Fat, Insulin Resistance
Keywords: Obesity, Calorie restriction, Eicosapentaenoic acid (EPA), Lipoic acid, Weight loss, Insulin sensitivity, Lipid metabolism, Adipokines
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
Study start: Jan 2010
Primary completion: Dec 2011 (actual)
Study completion: Dec 2012 (actual)
First posted: 7 Jun 2010 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Control group	Placebo comparator	Dietary Supplement: Double blind dietary intervention with EPA and lipoic acidDietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements
EPA group	Experimental	Dietary Supplement: Double blind dietary intervention with EPA and lipoic acidDietary 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).
Lipoic acid group	Experimental	Dietary Supplement: Double blind dietary intervention with EPA and lipoic acidDietary 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)
EPA+LA group	Experimental	Dietary Supplement: Double blind dietary intervention with EPA and lipoic acidDietary 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).

Who may qualify

Ages: 20 to 45 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Double blind dietary intervention with EPA and lipoic acidPlacebo-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).	Dietary supplement	Control group, EPA group, EPA+LA group, Lipoic acid group

Primary outcome

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.

13 secondary outcomes

Blood Pressure and Cardiovascular Risk biomarkers
Time frame: Baseline
Blood Pressure and Cardiovascular Risk biomarkers
Time frame: Week 10 (end of treatment)
Energy expenditure
Time frame: Baseline
Energy expenditure
Time frame: Week 10 (end of treatment)
Satiety
Time frame: Baseline
Satiety
Time frame: Week 10 (end of treatment)
Serum inflammation biomarkers
Time frame: Baseline
Serum inflammation biomarkers
Time frame: Week 10 (end of treatment)
Serum oxidative stress biomarkers
Time frame: Baseline
Serum oxidative stress biomarkers
Time frame: Week 10 (end of treatment)
Adipose tissue gene profile and function analysis
Time frame: Week 10 (end of treatment)
Metabolomic and lipidomic profile
Time frame: Baseline
Metabolomic and lipidomic profile
Time frame: Week 10 (end of treatment)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
Background: PubMed 19588730Prieto-Hontoria PL, Perez-Matute P, Fernandez-Galilea M, Barber A, Martinez JA, Moreno-Aliaga MJ. Lipoic acid prevents body weight gain induced by a high fat diet in rats: effects on intestinal sugar transport. J Physiol Biochem. 2009 Mar;65(1):43-50. doi: 10.1007/BF03165968.
Background: PubMed 20352620Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid up-regulates apelin secretion and gene expression in 3T3-L1 adipocytes. Mol Nutr Food Res. 2010 May;54 Suppl 1:S104-11. doi: 10.1002/mnfr.200900522.
Background: PubMed 19296827Lorente-Cebrian S, Bustos M, Marti A, Martinez JA, Moreno-Aliaga MJ. Eicosapentaenoic acid stimulates AMP-activated protein kinase and increases visfatin secretion in cultured murine adipocytes. Clin Sci (Lond). 2009 Aug 14;117(6):243-9. doi: 10.1042/CS20090020.
Background: PubMed 18829285Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Marti A, Martinez JA, Moreno-Aliaga MJ. Down-regulation in muscle and liver lipogenic genes: EPA ethyl ester treatment in lean and overweight (high-fat-fed) rats. J Nutr Biochem. 2009 Sep;20(9):705-14. doi: 10.1016/j.jnutbio.2008.06.013. Epub 2008 Sep 30.
Background: PubMed 18807107Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Baena MJ, Marti A, Martinez JA, Moreno-Aliaga MJ. Differential inflammatory status in rats susceptible or resistant to diet-induced obesity: effects of EPA ethyl ester treatment. Eur J Nutr. 2008 Oct;47(7):380-6. doi: 10.1007/s00394-008-0738-3. Epub 2008 Sep 18.
Background: PubMed 18755047Perez-Echarri N, Perez-Matute P, Marcos-Gomez B, Martinez JA, Moreno-Aliaga MJ. Effects of eicosapentaenoic acid ethyl ester on visfatin and apelin in lean and overweight (cafeteria diet-fed) rats. Br J Nutr. 2009 Apr;101(7):1059-67. doi: 10.1017/S0007114508048307. Epub 2008 Aug 28.
Background: PubMed 17298710Perez-Matute P, Perez-Echarri N, Martinez JA, Marti A, Moreno-Aliaga MJ. Eicosapentaenoic acid actions on adiposity and insulin resistance in control and high-fat-fed rats: role of apoptosis, adiponectin and tumour necrosis factor-alpha. Br J Nutr. 2007 Feb;97(2):389-98. doi: 10.1017/S0007114507207627.
Background: PubMed 16900083Marrades MP, Martinez JA, Moreno-Aliaga MJ. Differences in short-term metabolic responses to a lipid load in lean (resistant) vs obese (susceptible) young male subjects with habitual high-fat consumption. Eur J Clin Nutr. 2007 Feb;61(2):166-74. doi: 10.1038/sj.ejcn.1602500. Epub 2006 Aug 9.
Background: PubMed 16325777Marrades MP, Milagro FI, Martinez JA, Moreno-Aliaga MJ. Differential expression of aquaporin 7 in adipose tissue of lean and obese high fat consumers. Biochem Biophys Res Commun. 2006 Jan 20;339(3):785-9. doi: 10.1016/j.bbrc.2005.11.080. Epub 2005 Nov 22.
Background: PubMed 18491071Ramel A, Martinez A, Kiely M, Morais G, Bandarra NM, Thorsdottir I. Beneficial effects of long-chain n-3 fatty acids included in an energy-restricted diet on insulin resistance in overweight and obese European young adults. Diabetologia. 2008 Jul;51(7):1261-8. doi: 10.1007/s00125-008-1035-7. Epub 2008 May 20.
Background: PubMed 18602429Parra D, Ramel A, Bandarra N, Kiely M, Martinez JA, Thorsdottir I. A diet rich in long chain omega-3 fatty acids modulates satiety in overweight and obese volunteers during weight loss. Appetite. 2008 Nov;51(3):676-80. doi: 10.1016/j.appet.2008.06.003. Epub 2008 Jun 14.
Background: PubMed 19487105Ramel A, Martinez JA, Kiely M, Bandarra NM, Thorsdottir I. Moderate consumption of fatty fish reduces diastolic blood pressure in overweight and obese European young adults during energy restriction. Nutrition. 2010 Feb;26(2):168-74. doi: 10.1016/j.nut.2009.04.002. Epub 2009 May 31.
European Master´s Degree in Feeding, Nutrition and MetabolismLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Maria J Moreno-Aliaga, PhD principal investigator

University of Navarra

Alfredo Martínez, PhD study director

University of Navarra

Santiago Navas-Carretero, PhD study chair

University of Navarra

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Double blind dietary intervention with EPA and lipoic acid in people with Obesity and Body Fat, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weight Loss (time frame: Week 0 (baseline)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01138774, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.