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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01138774
• Date of registration: 21/05/2010
• Primary sponsor: Clinica Universidad de Navarra, Universidad de Navarra
• Public title: Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) in Human Obesity OBEPALIP
• Scientific title: Cellular and Molecular Effects of Lipoic Acid and Eicosapentaenoic Acid (EPA) on Adipose Tissue: Potential Application in Human Obesity
• Date of first enrolment: January 2010
• Target sample size: 80
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT01138774
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Spain

Contacts

• Name: Alfredo Martínez, PhD
• Affiliation: University of Navarra

• Name: Maria J Moreno-Aliaga, PhD
• Affiliation: University of Navarra

• Name: Santiago Navas-Carretero, PhD
• Affiliation: University of Navarra

Key inclusion & exclusion criteria

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)



Age minimum: 20 Years
Age maximum: 45 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Body Fat

Insulin Resistance

Obesity

Intervention(s)

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

Primary Outcome(s)

Body composition and Anthropometric parameters [Time Frame: Week 0 (Baseline)]

Body composition and anthropometric parameters [Time Frame: Week 10 (end of treatment)]

Glucose metabolism parameters [Time Frame: Week 0 (baseline)]

Glucose metabolism parameters [Time Frame: Week 10 (end of treatment)]

Lipid metabolism biomarkers [Time Frame: Week 0 (baseline)]

Lipid metabolism biomarkers [Time Frame: Week 10 (end of treatment)]

Weight Loss [Time Frame: Week 0 (baseline)]

Weight Loss [Time Frame: Week 10 (end of treatment)]

Weight Loss [Time Frame: Week 2]

Weight Loss [Time Frame: Week 4]

Weight Loss [Time Frame: week 6]

Weight Loss [Time Frame: Week 8]

Secondary Outcome(s)

Adipose tissue gene profile and function analysis [Time Frame: Week 10 (end of treatment)]

Blood Pressure and Cardiovascular Risk biomarkers [Time Frame: Baseline]

Blood Pressure and Cardiovascular Risk biomarkers [Time Frame: Week 10 (end of treatment)]

Energy expenditure [Time Frame: Baseline]

Energy expenditure [Time Frame: Week 10 (end of treatment)]

Metabolomic and lipidomic profile [Time Frame: Baseline]

Metabolomic and lipidomic profile [Time Frame: Week 10 (end of treatment)]

Satiety [Time Frame: Baseline]

Satiety [Time Frame: Week 10 (end of treatment)]

Serum inflammation biomarkers [Time Frame: Baseline]

Serum inflammation biomarkers [Time Frame: Week 10 (end of treatment)]

Serum oxidative stress biomarkers [Time Frame: Baseline]

Serum oxidative stress biomarkers [Time Frame: Week 10 (end of treatment)]

Secondary ID(s)

OBEPALIP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors