Clinical trial NCT04901052: Effects of N-3 Intake on Lipid Profile, Biochemical and Inflammatory Markers in Subjects with Obesity
Official title: Effect of a Diet Supplemented with Omega-3 on Biochemical Variables, Cytokine Concentration and Fatty Acid Profile in Subjects with Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Dietary Supplementations
Anti-Inflammatory Agent
Lead sponsor: University of Guadalajara
Sponsor class: OTHER
Collaborators: name: Centro Universitario de Ciencias de la Salud, Mexico
name: Hospital Civil de Guadalajara
First posted: 2021-05-25
Enrollment: 58
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Parallel with placebo
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The fatty acid profile quantification
timeFrame: Mean change from baseline (0 Month) to end of treatment at 4th Month
measure: Pro-inflammatory and Anti-inflammatory Cytokines profile in serum
timeFrame: Mean change from baseline (0 Month) to end of treatment at 4th Month
Secondary outcomes:
measure: Changes in Weight
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
measure: Changes in Body Mass Index (BMI)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
measure: Changes in Waist Circumference
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
measure: Changes in Fat Mass
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
measure: Changes in Serum Glucose
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
measure: Changes in Serum Insulin
timeFrame: At the baseline (0 Month) and the 4th month
measure: Changes in homeostatic model assessment - insulin resistance (HOMA-IR)
timeFrame: At the baseline (0 Month) and the 4th month
measure: Changes in Total Cholesterol
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
measure: Changes in High-density lipoprotein (c-HDL)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
measure: Changes in Low-density lipoprotein (c-LDL)
timeFrame: At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: University of Guadalajara
state: Jaliscco
city: Guadalajara
country: Mexico
facility: Erika Martínez-López
state: Jalisco
Study officials:
affiliation: University of Guadalajara
name: Erika Martinez-Lopez, PhD
role: STUDY_DIRECTOR
References:
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