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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01138774
Other study ID # OBEPALIP
Secondary ID
Status Completed
Phase N/A
First received May 21, 2010
Last updated May 27, 2015
Start date January 2010
Est. completion date December 2012

Study information

Verified date February 2012
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical 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.


Recruitment information / eligibility

Status Completed
Enrollment 103
Est. completion date December 2012
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 45 Years
Eligibility 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).

Locations

Country Name City State
Spain Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra Pamplona Navarra

Sponsors (1)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Lorente-Cebrián 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. — View Citation

Lorente-Cebrián 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. — View Citation

Marrades MP, Martínez 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. Epub 2006 Aug 9. — View Citation

Marrades MP, Milagro FI, Martínez 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. Epub 2005 Nov 22. — View Citation

Navas-Carretero S, Pérez-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. — View Citation

Parra D, Ramel A, Bandarra N, Kiely M, Martínez 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. — View Citation

Pérez-Echarri N, Pérez-Matute P, Marcos-Gómez B, Baena MJ, Marti A, Martínez 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. — View Citation

Pérez-Echarri N, Pérez-Matute P, Marcos-Gómez B, Marti A, Martínez 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. — View Citation

Pérez-Echarri N, Pérez-Matute P, Marcos-Gómez B, Martínez 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. — View Citation

Pérez-Matute P, Pérez-Echarri N, Martínez 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. — View Citation

Prieto-Hontoria PL, Pérez-Matute P, Fernández-Galilea M, Barber A, Martínez 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. — View Citation

Ramel A, Martinéz 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. — View Citation

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. — View Citation

* Note: There are 13 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Weight Loss Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg. Week 0 (baseline) No
Primary Weight Loss Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg. Week 2 No
Primary Weight Loss Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg. Week 4 No
Primary Weight Loss Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg. week 6 No
Primary Weight Loss Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg. Week 8 No
Primary Weight Loss Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg. Week 10 (end of treatment) No
Primary 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. Week 0 (Baseline) No
Primary 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. Week 10 (end of treatment) No
Primary Glucose metabolism parameters Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index Week 0 (baseline) No
Primary Glucose metabolism parameters Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index Week 10 (end of treatment) No
Primary Lipid metabolism biomarkers Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies. Week 0 (baseline) No
Primary Lipid metabolism biomarkers Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies. Week 10 (end of treatment) No
Secondary Blood Pressure and Cardiovascular Risk biomarkers Blood pressure, PAI-1 and VEGF will be measured. Baseline No
Secondary Blood Pressure and Cardiovascular Risk biomarkers Blood pressure, PAI-1 and VEGF will be measured. Week 10 (end of treatment) No
Secondary Energy expenditure Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits Baseline No
Secondary Energy expenditure Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits Week 10 (end of treatment) No
Secondary Satiety Satiety will be estimated by using a VAS questionnaire Baseline No
Secondary Satiety Satiety will be estimated by using a VAS questionnaire Week 10 (end of treatment) No
Secondary Serum inflammation biomarkers TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin Baseline No
Secondary Serum inflammation biomarkers TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin Week 10 (end of treatment) No
Secondary Serum oxidative stress biomarkers Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD). Baseline No
Secondary Serum oxidative stress biomarkers Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD). Week 10 (end of treatment) No
Secondary 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. Week 10 (end of treatment) No
Secondary 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). Baseline No
Secondary 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). Week 10 (end of treatment) No
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