Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04901052
Status:
COMPLETED
Last Update Posted:
2021-05-28
First Post:
2021-05-20
Brief Title:
Effects of n-3 Intake on Lipid Profile Biochemical and Inflammatory Markers in Subjects With Obesity
Sponsor:
University of Guadalajara
Organization:
University of Guadalajara
Study Overview
Official Title:
Effect of a Diet Supplemented With Omega-3 on Biochemical Variables Cytokine Concentration and Fatty Acid Profile in Subjects With Obesity
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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-6n-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 11 and 51 to maintain a healthy balance Purpose Compare the effect of a diet n6n3 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 v22 software
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 v22 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-StJeor 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-6omega-3 close to 51 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 15 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
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-StJeor 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-6omega-3 close to 51 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 15 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None