Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity (OBEPALIP)
2015년 5월 27일 업데이트: 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.
연구 개요
상태
완전한
연구 유형
중재적
등록 (실제)
103
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Navarra
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Pamplona, Navarra, 스페인, 31008
- Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
20년 (성인)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
여성
설명
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)
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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위약 비교기: Control group
Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements
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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).
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실험적: 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).
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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).
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실험적: 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)
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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).
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실험적: 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).
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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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Weight Loss
기간: Week 0 (baseline)
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Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
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Week 0 (baseline)
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Weight Loss
기간: Week 2
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Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
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Week 2
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Weight Loss
기간: Week 4
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Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
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Week 4
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Weight Loss
기간: week 6
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Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
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week 6
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Weight Loss
기간: Week 8
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Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
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Week 8
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Weight Loss
기간: Week 10 (end of treatment)
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Volunteers will attend the Nutritional Intervention unit (University of Navarra), where their weight will be measured to the nearest 0.1 kg.
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Week 10 (end of treatment)
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Body composition and Anthropometric parameters
기간: Week 0 (Baseline)
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Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
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Week 0 (Baseline)
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Body composition and anthropometric parameters
기간: Week 10 (end of treatment)
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Changes in body composition will be analyzed by Dual X-ray Absorptiometry (DXA) and by bioimpedance, and hip and waist circumferences will be measured.
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Week 10 (end of treatment)
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Glucose metabolism parameters
기간: Week 0 (baseline)
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Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
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Week 0 (baseline)
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Glucose metabolism parameters
기간: Week 10 (end of treatment)
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Fasting serum glucose, Fasting serum insulin, Oral Glucose Tolerance Test, HOMA index
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Week 10 (end of treatment)
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Lipid metabolism biomarkers
기간: Week 0 (baseline)
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Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
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Week 0 (baseline)
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Lipid metabolism biomarkers
기간: Week 10 (end of treatment)
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Serum total-cholesterol, HDL-cholesterol, LDL-cholesterol, triacylglycerols, free fatty acids, ketone bodies.
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Week 10 (end of treatment)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Blood Pressure and Cardiovascular Risk biomarkers
기간: Baseline
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Blood pressure, PAI-1 and VEGF will be measured.
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Baseline
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Blood Pressure and Cardiovascular Risk biomarkers
기간: Week 10 (end of treatment)
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Blood pressure, PAI-1 and VEGF will be measured.
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Week 10 (end of treatment)
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Energy expenditure
기간: Baseline
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Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
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Baseline
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Energy expenditure
기간: Week 10 (end of treatment)
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Energy expenditure will be estimated by indirect calorimetry, and T3, T4 and TSH levels will be analysed by ELISA kits
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Week 10 (end of treatment)
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Satiety
기간: Baseline
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Satiety will be estimated by using a VAS questionnaire
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Baseline
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Satiety
기간: Week 10 (end of treatment)
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Satiety will be estimated by using a VAS questionnaire
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Week 10 (end of treatment)
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Serum inflammation biomarkers
기간: Baseline
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TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
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Baseline
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Serum inflammation biomarkers
기간: Week 10 (end of treatment)
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TNF-alpha, IL-6, C-reactive protein, serum A-amiloid, Leptin, Adiponectin, Visfatin
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Week 10 (end of treatment)
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Serum oxidative stress biomarkers
기간: Baseline
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Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
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Baseline
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Serum oxidative stress biomarkers
기간: Week 10 (end of treatment)
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Total and Reduced Glutathione, Glutathione Peroxidase, MDA, Superoxide Dismutase-2 (Mn-SOD).
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Week 10 (end of treatment)
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Adipose tissue gene profile and function analysis
기간: Week 10 (end of treatment)
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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.
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Week 10 (end of treatment)
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Metabolomic and lipidomic profile
기간: Baseline
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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).
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Baseline
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Metabolomic and lipidomic profile
기간: Week 10 (end of treatment)
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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).
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Week 10 (end of treatment)
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Maria J Moreno-Aliaga, PhD, University of Navarra
- 연구 책임자: Alfredo Martínez, PhD, University of Navarra
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 1월 1일
기본 완료 (실제)
2011년 12월 1일
연구 완료 (실제)
2012년 12월 1일
연구 등록 날짜
최초 제출
2010년 5월 21일
QC 기준을 충족하는 최초 제출
2010년 6월 4일
처음 게시됨 (추정)
2010년 6월 7일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2015년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2015년 5월 27일
마지막으로 확인됨
2012년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .