The Effect of 12 Weeks of Conjugated Linoleic Acid on Obesity Markers, Lung Functions, Lipid Profile and Inflammation in Overweight and Obese Women: Double-blind Randomised Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- The change in Lean body mass from baseline to 12 weeks
研究概览
简要总结
Conjugated linoleic acid or CLA, is one of the food supplements that could be found in meat, fats, and dairy products of ruminants which has been fed grass not on grains. CLA has shown anti-cancer, anti-obesity, and anti-inflammatory effects in several animal modules, but the results of the human studies were not consistent. Also, a very limited number of studies looked at the CLA effect on the respiratory system. The study will look at the effect of 12 weeks of supplementation of conjugated linoleic acid on obesity markers, lung functions, lipid profile, and inflammation in overweight and obese women in a double-blind randomized control trial.
The study looked at the inflammation using different approaches, where it looked at the expression of adhesion molecules on the proinflammatory monocytes as well as it analysed the expression of the stress proteins Heat-shock proteins (HSPA1A and HSPB1)on the PBMCs.
详细描述
This is a double-blind randomized control trial with parallel design, where consented overweight and obese women from Chester city in the UK will be randomly assigned into two groups one group CLA will receive 4.5 g/day CLA mixture capsules while the other group will receive a placebo.
Participants will attend three clinics and by the end of each clinic, the participants will be asked to provide 20 ml venous blood samples for the analysis of the biological marker. Participants' anthropometric, body composition, lung functions, Leptin adiponectin, lipid profile, Adhesion molecules CD14, CD16, CD11b, and CD62L, HSPA1A, and HSPB1 will be assessed at three time points, at baseline after 6 and 12 weeks. The level of CLA in the plasma, as well as lipid profile (HDL, LDL, TC, TG), will be measured at each time point
Participants will be asked to fill three food diaries before attending each clinic. Body composition will be measured using bioelectric impedance, lung functions will be assessed using spirometers, adiponectin and leptin will be assessed using ELISA, and finally, CD11b, CD62L, HSPA1A, and HSPB1 will be analysed using flow cytometer. Plasma level of c9, t11-CLA and t10, c12-CLA will be measured using flame ionized Gas chromatography, and the lipid profile will be assessed using ALERE AFINION™ AS100 ANALYZER.
Power calculation for the RCT Sample size calculation is done using G*Power software, a total of 20 participant is required, 10 participants in each group, to get an effect size of 1.3 kg/m2 change in BMI from baseline and SD of 0.45, 0.05 margin of error, 95% power and 95% confidence interval. Considering a 150% drop out the total number will be 50, 25 in each group.
Participants' randomisation will be performed by an independent third party who is not involved in the current trial. Participants will be randomised into blocks using (www.randomization.com) which generate the randomisation plan. All the capsules will be packed in a light protective dark brown tamper-proof container. The randomised participants will be either allocated to the CLA group or the placebo group. CLA and placebo capsules will have the same shape and colour, and both the participants and researcher will be blind to the treatments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Able to swallow capsules
- •Overweight and obese women (BMI≥25)
- •Forced expiratory volume FEV1≥ 70%
排除标准
- •Participants taking antibiotics,
- •Participants taking weight loss medications
- •Pregnant and breastfeeding women,
- •Women with current or a history of severe lung disease
结局指标
主要结局
The change in Lean body mass from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
Lean body mass (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in percentage body fat from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
Percentage body fat will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in percentage lean body mass from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
Percentage lean body mass will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in waist circumference from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
Waist circumference will be measured by cm using the tab
The change in body weight from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
Body weight (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in total body fat from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
total body fat (Kg) will be measured using Bioelectric impedance technique (Tanita MC-780)
The change in BMI from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
weight and height will be combined to report BMI in kg/m\^2
The change in waist to hip ratio from baseline to 12 weeks
时间窗: 0, 6, 12 Weeks
Waist to hip ratio will be calculated by dividing the waist circumference cm over the hip circumference
次要结局
- The change in Triglycerides (TG) from baseline to 12 weeks(0, 6, 12 weeks)
- The change in Total Cholesterol (TC) from baseline to 12 weeks(0, 6, 12 weeks)
- The change in Low Density Lipoprotein (LDL) from baseline to 12 weeks(0, 6, 12 weeks)
- The change in (High Density Lipoprotein) HDL from baseline to 12 weeks(0, 6, 12 weeks)