Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity

NCT01138774 | Completed

• 1 other identifier: OBEPALIP
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Body Fat; Insulin Resistance

Keywords

Obesity; Calorie restriction; Eicosapentaenoic acid (EPA); Lipoic acid; Weight loss; Insulin sensitivity; Lipid metabolism; Adipokines; Inflammation; Oxidative stress; Adipose tissue gene profile; Metabolomic profile

Outcome Measures

Primary Outcomes (12)

• 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.

  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)

Secondary Outcomes (13)

• Blood Pressure and Cardiovascular Risk biomarkers

  Baseline

• Blood Pressure and Cardiovascular Risk biomarkers

  Week 10 (end of treatment)

• Energy expenditure

  Baseline

• Energy expenditure

  Week 10 (end of treatment)

• Satiety

  Baseline

Study Arms (4)

Control group

PLACEBO COMPARATOR

Dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline + placebos supplements

Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid

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).

Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid

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)

Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid

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).

Dietary Supplement: Double blind dietary intervention with EPA and lipoic acid

Interventions

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).

Control group; EPA group; EPA+LA group; Lipoic acid group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinica Universidad de Navarra, Universidad de Navarra: lead

Study Sites (1)

Department of Nutrition, Food Science, Physiology and Toxicology. University of Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (15)

• 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.

  PMID: 19588730 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.

  PMID: 20352620 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.

  PMID: 19296827 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.

  PMID: 18829285 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.

  PMID: 18807107 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.

  PMID: 18755047 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.

  PMID: 17298710 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.

  PMID: 16900083 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.

  PMID: 16325777 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.

  PMID: 18491071 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.

  PMID: 18602429 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.

  PMID: 19487105 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.

  PMID: 19210857 BACKGROUND

• 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.

  PMID: 29743087 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.

  PMID: 26962183 DERIVED

Related Links

• European Master´s Degree in Feeding, Nutrition and Metabolism

MeSH Terms

Conditions

Obesity; Insulin Resistance; Weight Loss; Inflammation

Interventions

Thioctic Acid

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Body Weight Changes; Pathologic Processes

Intervention Hierarchy (Ancestors)

Carboxylic Acids; Organic Chemicals; Thiophenes; Sulfur Compounds; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Study Officials

• Maria J Moreno-Aliaga, PhD

  University of Navarra

  PRINCIPAL INVESTIGATOR

• Alfredo Martínez, PhD

  University of Navarra

  STUDY DIRECTOR

• Santiago Navas-Carretero, PhD

  University of Navarra

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2010
• First Posted: June 7, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: May 28, 2015

Record last verified: 2012-02

Locations

ES (1)