Study to Assess the Effects of DHA (Docosahexaenoic Acid) on Pro-resolving Anti-inflammatory Mediators in Obese Patients Undergoing Weight-loss Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Proresolution Index
研究概览
简要总结
Comparative, randomized, placebo-controlled, single-centre, single-blind clinical trial to assess the effectiveness of providing additional DHA omega-3 fatty acids supplements to increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.
详细描述
Will include obese patients (BMI between 30 and 35) who are following a standardized, multidisciplinary weight-loss programme (PronoKal® Method), which consists of a very-low-calorie diet based on protein packets and vegetables with a low glycemic index, into which natural foods are gradually reintroduced, accompanied by physical exercise and emotional support.
Patients who are being treated with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones); and patients with immune disorders (rheumatoid arthritis, Lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) who may alter the biological markers of inflammation,will be excluded.
Treatment: In addition to the vitamin and oligoelement supplements which are part of the standard weight-loss programme, the patients will receive an additional 500 mg/day supplement of DHA omega-3 fatty acids in capsule form (study group) or a placebo capsule (control group).
The follow up will be 6 months and patients will be monitored over the course of 6 control visits: baseline, 7 days, 15 days, 30 days, 60 days and 180 days.
The main objective is to assess the effectiveness of providing additional DHA supplements to increase the levels of pro-resolving and anti-inflammatory lipid mediators and decrease the biological markers of chronic inflammation in obese patients following a weight-loss programme.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 75 years
- •Obese patients with Body Mass Index between 30 and 35
- •Patients who, regardless of their inclusion in this study, are going to follow the standardized weight-loss programme (PronoKal® Method)
- •Patients who agree to participate and sign the Informed Consent form
排除标准
- •Treatment with Omega-3 fatty acid supplements for other reasons during the month prior to inclusion in the trial
- •Treatment with acetylsalicylic acid (ASA), non-steroidal anti-inflammatory drugs (NSAIDS), corticoids or thiazolidinedione antidiabetic drugs (glitazones)
- •Pregnant or nursing patients
- •Haemopathy, including clotting disorders
- •Treatment with dicoumarin anticoagulants (Sintrom®)
- •Cancer or a history of cancer who have not received the oncologist's release
- •Type 1 or type 2 diabetes mellitus
- •Immune disorders (rheumatoid arthritis, lupus, etc.) and/or inflammatory disease (ulcerative colitis, Crohn's disease, etc.) that may alter the biological markers of inflammation
- •Patients not expected to attend monitoring visits
结局指标
主要结局
Proresolution Index
时间窗: 6 months
Proresolution index is the ratio of sum of proresolving mediators/sum of proinflammatory mediators
Sum of Proresolving Mediators at 6 Months
时间窗: 6 months
Sum of proresolving mediators at 6 months
Sum of Proinflammatory Mediators at 6 Months
时间窗: 6 months
Sum of proinflammatory mediators at 6 months
次要结局
- Waist Circumference at 6 Months(6 months)
- Body Mass Index at 6 Months(6 months)
- C-reactive Protein (CRP) at 6 Months(6 months)
- Adiponectin at 2 Months(2 months)
- Adiponectin at 6 Months(6 months)
- Tnf Alpha at 2 Months(2 months)
- C-reactive Protein (CRP) at 2 Months(2 months)
- Weight at 6 Months(6 months)
- Interleukin-6 at 2 Months(2 months)
- 8-HETE at 6 Months(6 months)
- TXB2 at 2 Months(2 months)
- 7-HDOHE at 2 Months(2 months)
- RVD2 at 2 Months(2 months)
- 15-HETE at 2 Months(2 months)
- 15-HETE at 6 Months(6 months)
- 5-HETE at 2 Months(2 months)
- TXB2 at 6 Months(6 months)
- PGE2 at 2 Months(2 months)
- LTB4 at 2 Months(2 months)
- 7SMAR1 at 2 Months(2 months)
- 7SMAR1 at 6 Months(6 months)
- Tnf Alpha at 6 Months(6 months)
- Resistin at 6 Months(6 months)
- Leptin at 2 Months(2 months)
- Leptin at 6 Months(6 months)
- 12-HETE at 2 Months(2 month)
- Interleukin-6 at 6 Months(6 months)
- Resistin at 2 Months(2 months)
- 12-HETE at 6 Months(6 months)
- 8-HETE at 2 Months(2 months)
- 5-HETE at 6 Months(6 months)
- PGE2 at 6 Months(6 months)
- 14-HDOHE at 6 Months(6 months)
- RVD2 at 6 Months(6 months)
- Sum of Proinflammatory Mediators at 2 Months(2 months)
- Sum of Proresolving Mediators at 2 Months(2 months)
- 17-HDOHE at 2 Months(2 months)
- LTB4 at 6 Months(6 months)
- 17-HDOHE at 6 Months(6 months)
- 14-HDOHE at 2 Months(2 months)
- 7-HDOHE at 6 Months(6 months)
- 4-HDOHE at 2 Months(2 months)
- 4-HDOHE at 6 Months(6 months)
- PD1 at 2 Months(2 months)
- PD1 at 6 Months(6 months)
- 7RMAR1 at 2 Months(2 months)
- 7RMAR1 at 6 Months(6 months)
- Proresolution Index(2 months)
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability(6 months)