Effects of N-3 Intake on Lipid Profile, Biochemical and Inflammatory Markers in Subjects with Obesity

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2019-03-15

Brief Summary

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Obesity is a chronic disease characterized by the excessive accumulation of adipose tissue that is harmful to health. Dietary habits modification through a caloric restriction, macronutrient distribution including linoleic and linolenic (n-6:n-3) polyunsaturated fatty acids (PUFAs) ratio, has been suggested for obesity management. It has been proposed that the optimal n-6: n-3 ratio should be between 1:1 and 5:1 to maintain a healthy balance. Purpose: Compare the effect of a diet n6:n3 ratio of polyunsaturated fatty acids with a group supplemented with n-3 PUFA on lipid profile in erythrocyte membrane, biochemical and inflammatory markers in subjects with obesity.

Methods: 58 subjects were randomly divided into two groups: fish oil group and the placebo group. Anthropometric and biochemical data were evaluated, cytokine levels was performed using the Bio-PlexPro™ HumanTh17Cytokine Assays (MagPix) panel. The fatty acid profile quantification in the erythrocyte membrane was carried out by gas chromatography. Statistical analysis was performed with Statistical Package for the Social Sciences (SPSS) v.22 software.

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Detailed Description

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A randomized clinical trial was conducted at the Institute of Translational Nutrigenetics and Nutrigenomics of the University of Guadalajara. All participants were recruited through flyers and social media invitations. Sample size was determined according to the mean difference formula for clinical trials. To achieve a statistical power of 80% and an alpha of 5%, a sample size of 19 participants in each study group was required. However, 58 obese individuals who met the selection criteria were randomized in n-3 group or placebo group.

Blood sample, height and weight were measured after 8-12 hour fast and wearing light clothes.

The nutritional intervention consisted in 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study. Fish oil group besides the diet was supplemented with omega 3, the dosage was 2 capsules per day, containing 1.5 g of total omega 3, of which 1000 mg were EPA and 500mg DHA. The omega 3 capsules were obtained from the same batch, and a toxicity analysis was performed to verify the safety or the placebo group (2 capsules per day made from sunflower oil).

This study was approved by the Ethics and Biosafety Committee of the Health Sciences Center, University of Guadalajara (Registration number CI-01219) and was carried out according to the Declaration of Helsinki (2013) and all the participants signed a written consent-informed.

Conditions

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Parallel with placebo

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Double blind

Study Groups

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n-3 supplementation group

The nutritional strategy consisted a hypocaloric diet high in n-3. A 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study plus Omega 3 supplementation, the dosage was 2 capsules per day, containing 1.5 g of omega 3, of which 1000 mg were EPA and 500mg DHA. The omega 3 capsules were obtained from the same batch.

Group Type EXPERIMENTAL

n-3 supplementation group

Intervention Type DIETARY_SUPPLEMENT

n-3 supplementation group (1.5g of omega 3)

Placebo group

The nutritional strategy consisted a hypocaloric diet high in n-3. A 20% reduction by the total estimated energy through the Mifflin-St.Jeor formula was calculated, following a 50% to carbohydrates, 20% to proteins and 30% to lipids distribution. All participants received a balanced nutritional plan of omega-6/omega-3 close to 5:1 ratio, according to estimated energy. Additionally, a high omega-3 foods list was proportioned to emphasize their consumption during the study plus placebo capsules (2 capsules per day made from sunflower oil)

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

Placebo group (sunflower oil)

Interventions

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n-3 supplementation group

n-3 supplementation group (1.5g of omega 3)

Intervention Type DIETARY_SUPPLEMENT

Placebo group

Placebo group (sunflower oil)

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Placebo group (sunflower oil)

Eligibility Criteria

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Inclusion Criteria

* Subjects of both sexes
* Mestizo from West Mexico
* Age between 30 to 50 years of age
* Sign the Informed Consent
* Diagnostic of Obesity type I and II according to BMI (30 - 40kg / m2)
* Waist circumference (WC) women ≥80cm, men ≥90cm
* Sedentary lifestyle ˂ 150 minutes per week

Exclusion Criteria

* Pregnant or breastfeeding women
* Diabetes disease
* Cardiovascular disease
* Any type of cancer disease Tobacco and alcohol (consumption ≥ 40 g of alcohol per day for men and ≥ 20 g for women)
* Participants that consume n-3 supplements, anti-inflammatory medications, or some type of lipid-lowering drugs in the past year

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes