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

NCT04901052 | Completed DMC

• 1 other identifier: CI-01219
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

Dietary Supplementations; Anti-Inflammatory Agent

Outcome Measures

Primary Outcomes (2)

• 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

• 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: 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.

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

Secondary Outcomes (10)

• Changes in Weight

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

• Changes in Body Mass Index (BMI)

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

• Changes in Waist Circumference

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

• Changes in Fat Mass

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

• Changes in Serum Glucose

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

Study Arms (2)

n-3 supplementation group

EXPERIMENTAL

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.

Dietary Supplement: n-3 supplementation group

Placebo group

PLACEBO COMPARATOR

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)

Dietary Supplement: Placebo group

Interventions

n-3 supplementation group DIETARY_SUPPLEMENT

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

n-3 supplementation group

Placebo group DIETARY_SUPPLEMENT

Placebo group (sunflower oil)

Also known as: Placebo group (sunflower oil)

Placebo group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Guadalajara: lead
• Centro Universitario de Ciencias de la Salud, Mexico: collaborator
• Hospital Civil de Guadalajara: collaborator

Study Sites (2)

University of Guadalajara

Guadalajara, Jaliscco, 44280, Mexico

Location

Erika Martínez-López

Guadalajara, Jalisco, 44340, Mexico

Location

Related 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 2018 Feb 27.

  PMID: 29621669 BACKGROUND

• Torres-Castillo N, Silva-Gomez JA, Campos-Perez W, Barron-Cabrera E, Hernandez-Canaveral I, Garcia-Cazarin M, Marquez-Sandoval Y, Gonzalez-Becerra K, Barron-Gallardo C, Martinez-Lopez E. High Dietary omega-6:omega-3 PUFA Ratio Is Positively Associated with Excessive Adiposity and Waist Circumference. Obes Facts. 2018;11(4):344-353. doi: 10.1159/000492116. Epub 2018 Aug 10.

  PMID: 30092569 BACKGROUND

• 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.

  PMID: 24342605 BACKGROUND

• Bruun JM, Lihn AS, Madan AK, Pedersen SB, Schiott 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. doi: 10.1152/ajpendo.00269.2003. Epub 2003 Sep 16.

  PMID: 13129857 BACKGROUND

• 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.2010.07.041.

  PMID: 20813258 BACKGROUND

• 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. Epub 2014 Apr 24.

  PMID: 24913088 BACKGROUND

Related Links

• World Health Organization

MeSH Terms

Conditions

Obesity

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Erika Martinez-Lopez, PhD

  University of Guadalajara

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Double blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Parallel with placebo

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: May 25, 2021
• Study Start: January 10, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: November 15, 2024

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (2)