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

University of Navarra

Status: Completed

Conditions: Body Fat; Insulin Resistance; Obesity

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01138774

OBEPALIP

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 4 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

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

EPA group

Experimental group

Description:

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).

Treatment:

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

Lipoic acid group

Experimental group

Description:

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)

Treatment:

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

EPA+LA group

Experimental group

Description:

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).

Treatment:

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