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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04901052
Enrollment
58
Registered
2021-05-25
Start date
2018-01-10
Completion date
2019-03-15
Last updated
2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Dietary Supplementations, Anti-Inflammatory Agent

Brief summary

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.

Detailed description

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.

Interventions

DIETARY_SUPPLEMENTn-3 supplementation group

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

DIETARY_SUPPLEMENTPlacebo group

Placebo group (sunflower oil)

Sponsors

Centro Universitario de Ciencias de la Salud, Mexico
CollaboratorOTHER
Hospital Civil de Guadalajara
CollaboratorOTHER
University of Guadalajara
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Double blind

Intervention model description

Randomized Parallel with placebo

Eligibility

Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
The fatty acid profile quantificationMean change from baseline (0 Month) to end of treatment at 4th MonthAll 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).
Pro-inflammatory and Anti-inflammatory Cytokines profile in serumMean change from baseline (0 Month) to end of treatment at 4th MonthThe 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

MeasureTime frameDescription
Changes in Waist CircumferenceAt 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.
Changes in Fat MassAt the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th monthThe Fat Mass was measured in kilograms by electrical bioimpedance on InBody 370.
Changes in Serum GlucoseAt the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th monthIt was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Changes in Serum InsulinAt the baseline (0 Month) and the 4th monthWere determined through Insulin Model ELISA kit following the supplier's instructions.
Changes in WeightAt the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th monthThe weight was measured in kilograms on InBody 370
Changes in Total CholesterolAt the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th monthIt was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Changes in High-density lipoprotein (c-HDL)At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th monthIt was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.
Changes in Low-density lipoprotein (c-LDL)At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th monthIt was calculated using Friedewald formula
Changes in homeostatic model assessment - insulin resistance (HOMA-IR)At the baseline (0 Month) and the 4th monthSerum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews.
Changes in Body Mass Index (BMI)At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th monthWeight and height were be combined to report BMI in kg/m\^2

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026