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Completed

NCT Number: NCT04901052

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

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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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Guadalajara, Guadalajara, Jaliscco, Mexico

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

n-3 supplementation group

Dietary Supplement

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

Placebo Group

Dietary Supplement

Placebo group (sunflower oil)

Other names: Placebo group (sunflower oil)

Primary outcomes

  1. The fatty acid profile quantification

    Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month

    All the samples was performed in a Gas Chromatograph (GC) Agilent Technologies, 6850 network system coupled to an injector (Agilent Technologies, 7083 Series) with a column for fatty acids (Durabond, DB-23). flame ionization detector with helium as gas carrier (0.7 cm3 min-1) and a temperature ramp (110 °C - 220 °C).

  2. Pro-inflammatory and Anti-inflammatory Cytokines profile in serum

    Time frame: Mean change from baseline (0 Month) to end of treatment at 4th Month

    The pro-inflammatory and anti-inflammatory cytokines quantification were using Bio-Plex Pro™ Human cytokine Standard 17-Plex, Group I kit following the supplier's instructions, and the read was immediately by MAGPIX™ analyzer.

    The 17 cytokine include: IL1β, IL-1ra, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12p70, IL-13, IL-15, IL17A, G-CSF, GM-CSF, INF-γ, MCP-1, MIP1α, TNFα. Units of measure in pg/ml.

Secondary outcomes

  1. Changes in Weight

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

    The weight was measured in kilograms on InBody 370

  2. Changes in Body Mass Index (BMI)

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

    Weight and height were be combined to report BMI in kg/m^2

  3. Changes in Waist Circumference

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.

    Waist circumference was measured at the narrowest point between the edge of the inner rib and the iliac crest, with the participant in an abducted and relaxed position, after expiration using a Lufkin Executive® tape.

  4. Changes in Fat Mass

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

    The Fat Mass was measured in kilograms by electrical bioimpedance on InBody 370.

  5. Changes in Serum Glucose

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

    It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.

  6. Changes in Serum Insulin

    Time frame: At the baseline (0 Month) and the 4th month

    Were determined through Insulin Model ELISA kit following the supplier's instructions.

  7. Changes in homeostatic model assessment - insulin resistance (HOMA-IR)

    Time frame: At the baseline (0 Month) and the 4th month

    Serum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews.

  8. Changes in Total Cholesterol

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

    It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.

  9. Changes in High-density lipoprotein (c-HDL)

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

    It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.

  10. Changes in Low-density lipoprotein (c-LDL)

    Time frame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

    It was calculated using Friedewald formula

Sponsors and collaborators

Lead sponsor

University of Guadalajara

Other

Collaborators

  • Centro Universitario de Ciencias de la Salud, Mexico
  • Hospital Civil de Guadalajara

Registry information

Official study title

Effect of a Diet Supplemented With Omega-3 on Biochemical Variables, Cytokine Concentration and Fatty Acid Profile in Subjects With Obesity

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 25, 2021
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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