Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity (OBEPALIP)
27 maj 2015 uppdaterad av: Clinica Universidad de Navarra, Universidad de Navarra
Cellular and Molecular Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) on Adipose Tissue: Potential Application in Human Obesity
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
103
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Navarra
-
Pamplona, Navarra, Spanien, 31008
- Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
20 år till 45 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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)
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Placebo-jämförare: Control group
Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements
|
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).
|
|
Experimentell: 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).
|
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).
|
|
Experimentell: 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)
|
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).
|
|
Experimentell: 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).
|
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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Weight Loss
Tidsram: 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.
|
Week 0 (baseline)
|
|
Weight Loss
Tidsram: Week 2
|
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
Tidsram: Week 4
|
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
Tidsram: week 6
|
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
Tidsram: Week 8
|
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
Tidsram: 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.
|
Week 10 (end of treatment)
|
|
Body composition and Anthropometric parameters
Tidsram: 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.
|
Week 0 (Baseline)
|
|
Body composition and anthropometric parameters
Tidsram: 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.
|
Week 10 (end of treatment)
|
|
Glucose metabolism parameters
Tidsram: Week 0 (baseline)
|
Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
|
Week 0 (baseline)
|
|
Glucose metabolism parameters
Tidsram: Week 10 (end of treatment)
|
Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
|
Week 10 (end of treatment)
|
|
Lipid metabolism biomarkers
Tidsram: Week 0 (baseline)
|
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
|
Week 0 (baseline)
|
|
Lipid metabolism biomarkers
Tidsram: Week 10 (end of treatment)
|
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
|
Week 10 (end of treatment)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Blood Pressure and Cardiovascular Risk biomarkers
Tidsram: Baseline
|
Blood pressure, PAI-1 and VEGF will be measured.
|
Baseline
|
|
Blood Pressure and Cardiovascular Risk biomarkers
Tidsram: Week 10 (end of treatment)
|
Blood pressure, PAI-1 and VEGF will be measured.
|
Week 10 (end of treatment)
|
|
Energy expenditure
Tidsram: Baseline
|
Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
|
Baseline
|
|
Energy expenditure
Tidsram: 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
|
Week 10 (end of treatment)
|
|
Satiety
Tidsram: Baseline
|
Satiety will be estimated by using a VAS questionnaire
|
Baseline
|
|
Satiety
Tidsram: Week 10 (end of treatment)
|
Satiety will be estimated by using a VAS questionnaire
|
Week 10 (end of treatment)
|
|
Serum inflammation biomarkers
Tidsram: Baseline
|
TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
|
Baseline
|
|
Serum inflammation biomarkers
Tidsram: Week 10 (end of treatment)
|
TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
|
Week 10 (end of treatment)
|
|
Serum oxidative stress biomarkers
Tidsram: Baseline
|
Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
|
Baseline
|
|
Serum oxidative stress biomarkers
Tidsram: Week 10 (end of treatment)
|
Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
|
Week 10 (end of treatment)
|
|
Adipose tissue gene profile and function analysis
Tidsram: 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.
|
Week 10 (end of treatment)
|
|
Metabolomic and lipidomic profile
Tidsram: 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).
|
Baseline
|
|
Metabolomic and lipidomic profile
Tidsram: 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).
|
Week 10 (end of treatment)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Maria J Moreno-Aliaga, PhD, University of Navarra
- Studierektor: Alfredo Martínez, PhD, University of Navarra
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 januari 2010
Primärt slutförande (Faktisk)
1 december 2011
Avslutad studie (Faktisk)
1 december 2012
Studieregistreringsdatum
Först inskickad
21 maj 2010
Först inskickad som uppfyllde QC-kriterierna
4 juni 2010
Första postat (Uppskatta)
7 juni 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
28 maj 2015
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
27 maj 2015
Senast verifierad
1 februari 2012
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Störningar i glukosmetabolism
- Metaboliska sjukdomar
- Övernäring
- Näringsstörningar
- Övervikt
- Kroppsvikt
- Hyperinsulinism
- Fetma
- Insulinresistens
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Skyddsmedel
- Mikronäringsämnen
- Vitaminer
- Antioxidanter
- Vitamin B-komplex
- Tioctic syra
Andra studie-ID-nummer
- OBEPALIP
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .