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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04901052
• Other study ID #: CI-01219
• Status: Completed
• Phase: N/A
• Start date: January 10, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: May 2021
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• n-3 supplementation group
n-3 supplementation group (1.5g of omega 3)
• Placebo group
Placebo group (sunflower oil)

Locations

Country	Name	City	State
Mexico	Erika Martínez-López	Guadalajara	Jalisco
Mexico	University of Guadalajara	Guadalajara	Jaliscco

Sponsors (1)

Lead Sponsor	Collaborator
University of Guadalajara

Country where clinical trial is conducted

Mexico, 

References & Publications (6)

Albracht-Schulte K, Kalupahana NS, Ramalingam L, Wang S, Rahman SM, Robert-McComb J, Moustaid-Moussa N. Omega-3 fatty acids in obesity and metabolic syndrome: a mechanistic update. J Nutr Biochem. 2018 Aug;58:1-16. doi: 10.1016/j.jnutbio.2018.02.012. Epub — View Citation

Bruun JM, Lihn AS, Madan AK, Pedersen SB, Schiøtt KM, Fain JN, Richelsen B. Higher production of IL-8 in visceral vs. subcutaneous adipose tissue. Implication of nonadipose cells in adipose tissue. Am J Physiol Endocrinol Metab. 2004 Jan;286(1):E8-13. Epu — View Citation

Gurzell EA, Wiesinger JA, Morkam C, Hemmrich S, Harris WS, Fenton JI. Is the omega-3 index a valid marker of intestinal membrane phospholipid EPA+DHA content? Prostaglandins Leukot Essent Fatty Acids. 2014 Sep;91(3):87-96. doi: 10.1016/j.plefa.2014.04.001 — View Citation

Oh DY, Talukdar S, Bae EJ, Imamura T, Morinaga H, Fan W, Li P, Lu WJ, Watkins SM, Olefsky JM. GPR120 is an omega-3 fatty acid receptor mediating potent anti-inflammatory and insulin-sensitizing effects. Cell. 2010 Sep 3;142(5):687-98. doi: 10.1016/j.cell. — View Citation

Torres-Castillo N, Silva-Gómez JA, Campos-Perez W, Barron-Cabrera E, Hernandez-Cañaveral I, Garcia-Cazarin M, Marquez-Sandoval Y, Gonzalez-Becerra K, Barron-Gallardo C, Martinez-Lopez E. High Dietary ?-6:?-3 PUFA Ratio Is Positively Associated with Excess — View Citation

Vannice G, Rasmussen H. Position of the academy of nutrition and dietetics: dietary fatty acids for healthy adults. J Acad Nutr Diet. 2014 Jan;114(1):136-53. doi: 10.1016/j.jand.2013.11.001. Erratum in: J Acad Nutr Diet. 2014 Apr;114(4):644. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The fatty acid profile quantification	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).	Mean change from baseline (0 Month) to end of treatment at 4th Month
Primary	Pro-inflammatory and Anti-inflammatory Cytokines profile in serum	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: IL1ß, 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-?, MCP-1, MIP1a, TNFa. Units of measure in pg/ml.	Mean change from baseline (0 Month) to end of treatment at 4th Month
Secondary	Changes in Weight	The weight was measured in kilograms on InBody 370	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Secondary	Changes in Body Mass Index (BMI)	Weight and height were be combined to report BMI in kg/m^2	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Secondary	Changes in Waist Circumference	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.	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month.
Secondary	Changes in Fat Mass	The Fat Mass was measured in kilograms by electrical bioimpedance on InBody 370.	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Secondary	Changes in Serum Glucose	It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Secondary	Changes in Serum Insulin	Were determined through Insulin Model ELISA kit following the supplier's instructions.	At the baseline (0 Month) and the 4th month
Secondary	Changes in homeostatic model assessment - insulin resistance (HOMA-IR)	Serum glucose and Insulin levels were be combined to report HOMA-IR calculated as described by Matthews.	At the baseline (0 Month) and the 4th month
Secondary	Changes in Total Cholesterol	It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Secondary	Changes in High-density lipoprotein (c-HDL)	It was measured in mg/dL using a dry chemistry system in Vitros 350 equipment.	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month
Secondary	Changes in Low-density lipoprotein (c-LDL)	It was calculated using Friedewald formula	At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month

External Links

•   World Health Organization