Effect of a Diet Supplemented with Omega-3 on Biochemical Variables, Cytokine Concentration and Fatty Acid Profile in Subjects with Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 4
- 主要终点
- The fatty acid profile quantification
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
盲法说明
Double blind
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The fatty acid profile quantification
时间窗: Mean change from baseline (0 Month) to end of treatment at 4th Month
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).
Pro-inflammatory and Anti-inflammatory Cytokines profile in serum
时间窗: Mean change from baseline (0 Month) to end of treatment at 4th Month
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.
次要结局
- Changes in Serum Glucose(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 Low-density lipoprotein (c-LDL)(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month)
- Changes in Weight(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 Insulin(At the baseline (0 Month) and the 4th month)
- Changes in homeostatic model assessment - insulin resistance (HOMA-IR)(At the baseline (0 Month) and the 4th month)
- Changes in High-density lipoprotein (c-HDL)(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 Total Cholesterol(At the baseline (0 Month) and 1st month, 2nd month, 3th month and the 4th month)
研究者
ERIKA MARTINEZ-LOPEZ
Principal Investigator
University of Guadalajara