Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Centro Universitario de Ciencias de la Salud, Mexico | OTHER |
| Hospital Civil de Guadalajara | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| n-3 supplementation group | Dietary Supplement | n-3 supplementation group (1.5g of omega 3) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in Body Mass Index (BMI) | Weight and height were be combined to report BMI in kg/m^2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Erika Martinez-Lopez, PhD | University of Guadalajara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guadalajara | Guadalajara | Jaliscco | 44280 | Mexico | ||
| Erika Martínez-López |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29621669 | Result | 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. | |
| 30092569 | Result | 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. |
| Label | URL |
|---|---|
| World Health Organization | View source |
Not provided
The individual participant data will not be shared to protect and safeguard the confidentiality data of the participants.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000074242 | Sunflower Oil |
| ID | Term |
|---|---|
| D010938 | Plant Oils |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
Not provided
Not provided
Randomized Parallel with placebo
Not provided
Not provided
Double blind
| Placebo group | Dietary Supplement | Placebo group (sunflower oil) |
|
|
| At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month |
| 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. |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Guadalajara |
| Jalisco |
| 44340 |
| Mexico |
| 24342605 | Result | 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. |
| 13129857 | Result | 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. |
| 20813258 | Result | 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. |
| 24913088 | Result | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |