Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity (OBEPALIP)
27. Mai 2015 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
103
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Navarra
-
Pamplona, Navarra, Spanien, 31008
- Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
-
-
Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
20 Jahre bis 45 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
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)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Placebo-Komparator: 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).
|
|
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).
|
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)
|
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).
|
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).
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Weight Loss
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Week 0 (baseline)
|
Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
|
Week 0 (baseline)
|
|
Glucose metabolism parameters
Zeitfenster: 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
Zeitfenster: Week 0 (baseline)
|
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
|
Week 0 (baseline)
|
|
Lipid metabolism biomarkers
Zeitfenster: Week 10 (end of treatment)
|
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
|
Week 10 (end of treatment)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Blood Pressure and Cardiovascular Risk biomarkers
Zeitfenster: Baseline
|
Blood pressure, PAI-1 and VEGF will be measured.
|
Baseline
|
|
Blood Pressure and Cardiovascular Risk biomarkers
Zeitfenster: Week 10 (end of treatment)
|
Blood pressure, PAI-1 and VEGF will be measured.
|
Week 10 (end of treatment)
|
|
Energy expenditure
Zeitfenster: Baseline
|
Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
|
Baseline
|
|
Energy expenditure
Zeitfenster: 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
Zeitfenster: Baseline
|
Satiety will be estimated by using a VAS questionnaire
|
Baseline
|
|
Satiety
Zeitfenster: Week 10 (end of treatment)
|
Satiety will be estimated by using a VAS questionnaire
|
Week 10 (end of treatment)
|
|
Serum inflammation biomarkers
Zeitfenster: Baseline
|
TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
|
Baseline
|
|
Serum inflammation biomarkers
Zeitfenster: 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
Zeitfenster: Baseline
|
Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
|
Baseline
|
|
Serum oxidative stress biomarkers
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Maria J Moreno-Aliaga, PhD, University of Navarra
- Studienleiter: Alfredo Martínez, PhD, University of Navarra
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Nützliche Links
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Januar 2010
Primärer Abschluss (Tatsächlich)
1. Dezember 2011
Studienabschluss (Tatsächlich)
1. Dezember 2012
Studienanmeldedaten
Zuerst eingereicht
21. Mai 2010
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
4. Juni 2010
Zuerst gepostet (Schätzen)
7. Juni 2010
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
28. Mai 2015
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
27. Mai 2015
Zuletzt verifiziert
1. Februar 2012
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Störungen des Glukosestoffwechsels
- Stoffwechselerkrankungen
- Überernährung
- Ernährungsstörungen
- Übergewicht
- Körpergewicht
- Hyperinsulinismus
- Fettleibigkeit
- Insulinresistenz
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Schutzmittel
- Mikronährstoffe
- Vitamine
- Antioxidantien
- Vitamin B-Komplex
- Thioctsäure
Andere Studien-ID-Nummern
- OBEPALIP
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .