Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity (OBEPALIP)
2015年5月27日 更新者：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.
調査の概要
状態
完了
研究の種類
介入
入学 (実際)
103
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Navarra
-
Pamplona、Navarra、スペイン、31008
- Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
20年～45年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
女性
説明
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)
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
プラセボコンパレーター：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).
|
|
実験的：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).
|
|
実験的：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).
|
|
実験的：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).
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight Loss
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Week 0 (baseline)
|
Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
|
Week 0 (baseline)
|
|
Glucose metabolism parameters
時間枠：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
時間枠：Week 0 (baseline)
|
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
|
Week 0 (baseline)
|
|
Lipid metabolism biomarkers
時間枠：Week 10 (end of treatment)
|
Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
|
Week 10 (end of treatment)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Blood Pressure and Cardiovascular Risk biomarkers
時間枠：Baseline
|
Blood pressure, PAI-1 and VEGF will be measured.
|
Baseline
|
|
Blood Pressure and Cardiovascular Risk biomarkers
時間枠：Week 10 (end of treatment)
|
Blood pressure, PAI-1 and VEGF will be measured.
|
Week 10 (end of treatment)
|
|
Energy expenditure
時間枠：Baseline
|
Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
|
Baseline
|
|
Energy expenditure
時間枠：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
時間枠：Baseline
|
Satiety will be estimated by using a VAS questionnaire
|
Baseline
|
|
Satiety
時間枠：Week 10 (end of treatment)
|
Satiety will be estimated by using a VAS questionnaire
|
Week 10 (end of treatment)
|
|
Serum inflammation biomarkers
時間枠：Baseline
|
TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
|
Baseline
|
|
Serum inflammation biomarkers
時間枠：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
時間枠：Baseline
|
Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
|
Baseline
|
|
Serum oxidative stress biomarkers
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Maria J Moreno-Aliaga, PhD、University of Navarra
- スタディディレクター：Alfredo Martínez, PhD、University of Navarra
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年1月1日
一次修了 (実際)
2011年12月1日
研究の完了 (実際)
2012年12月1日
試験登録日
最初に提出
2010年5月21日
QC基準を満たした最初の提出物
2010年6月4日
最初の投稿 (見積もり)
2010年6月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2015年5月28日
QC基準を満たした最後の更新が送信されました
2015年5月27日
最終確認日
2012年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。