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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements |
|
| 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). |
|
| 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) |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Double blind dietary intervention with EPA and lipoic acid | Dietary 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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 |
| 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 |
| 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 |
| 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 |
| 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) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure and Cardiovascular Risk biomarkers | Blood pressure, PAI-1 and VEGF will be measured. | Baseline |
| Blood Pressure and Cardiovascular Risk biomarkers | Blood pressure, PAI-1 and VEGF will be measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria J Moreno-Aliaga, PhD | University of Navarra | Principal Investigator |
| Alfredo MartÃnez, PhD | University of Navarra | Study Director |
| Santiago Navas-Carretero, PhD | University of Navarra | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra | Pamplona | Navarre | 31008 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19588730 | Background | 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. | |
| 20352620 | Background | 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. |
| Label | URL |
|---|---|
| European Master´s Degree in Feeding, Nutrition and Metabolism | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| D015431 | Weight Loss |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008063 | Thioctic Acid |
| ID | Term |
|---|---|
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
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|
| 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. | Week 10 (end of treatment) |
| Glucose metabolism parameters | Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index | Week 0 (baseline) |
| Glucose metabolism parameters | Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index | Week 10 (end of treatment) |
| Lipid metabolism biomarkers | Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies. | Week 0 (baseline) |
| Lipid metabolism biomarkers | Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies. | Week 10 (end of treatment) |
| 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 | Baseline |
| 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) |
| Satiety | Satiety will be estimated by using a VAS questionnaire | Baseline |
| Satiety | Satiety will be estimated by using a VAS questionnaire | Week 10 (end of treatment) |
| Serum inflammation biomarkers | TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin | Baseline |
| Serum inflammation biomarkers | TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin | Week 10 (end of treatment) |
| Serum oxidative stress biomarkers | Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD). | Baseline |
| Serum oxidative stress biomarkers | Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD). | 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. | 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). | 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). | Week 10 (end of treatment) |
| 19296827 | Background | 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. |
| 18829285 | Background | 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. |
| 18807107 | Background | 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. |
| 18755047 | Background | 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. |
| 17298710 | Background | 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. |
| 16900083 | Background | 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. |
| 16325777 | Background | 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. |
| 18491071 | Background | 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. |
| 18602429 | Background | 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. |
| 19487105 | Background | 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. |
| 19210857 | Background | 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. |
| 29743087 | Derived | 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. |
| 26962183 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D001836 | Body Weight Changes |
| D010335 | Pathologic Processes |
| D003067 |
| Coenzymes |
| D045762 | Enzymes and Coenzymes |
| D005227 | Fatty Acids |
| D008055 | Lipids |