Senanayake Vijitha K, Pu Shuaihua, Jenkins David A, Lamarche Benoît, Kris-Etherton Penny M, West Sheila G, Fleming Jennifer A, Liu Xiaoran, McCrea Cindy E, Jones Peter J
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba, 196 Innovation Drive, SmartPark, Winnipeg, MB R3T 6C5, Canada.
Trials. 2014 Apr 23;15:136. doi: 10.1186/1745-6215-15-136.
The Canola Oil Multicenter Intervention Trial (COMIT) was a randomized controlled crossover study designed to evaluate the effects of five diets that provided different oils and/or oil blends on cardiovascular disease (CVD) risk factors in individuals with abdominal obesity. The present objective is to report preliminary findings on plasma fatty acid profiles in volunteers with abdominal obesity, following the consumption of diets enriched with n-3, n-6 and n-9 fatty acids.
COMIT was conducted at three clinical sites, Winnipeg, Manitoba, Canada, Québec City, Québec, Canada and University Park, Pennsylvania, United States. Inclusion criteria were at least one of the followings: waist circumference (≥90 cm for males and ≥84 cm for females), and at least one other criterion: triglycerides ≥1.7 mmol/L, high density lipoprotein cholesterol <1 mmol/L (males) or <1.3 mmol/L (females), blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic), and glucose ≥5.5 mmol/L. Weight-maintaining diets that included shakes with one of the dietary oil blends were provided during each of the five 30-day dietary phases. Dietary phases were separated by four-week washout periods. Treatment oils were canola oil, high oleic canola oil, high oleic canola oil enriched with docosahexaenoic acid (DHA), flax oil and safflower oil blend, and corn oil and safflower oil blend. A per protocol approach with a mixed model analysis was decided to be appropriate for data analysis.
One hundred and seventy volunteers were randomized and 130 completed the study with a dropout rate of 23.5%. The mean plasma total DHA concentrations, which were analyzed among all participants as a measure of adherence, increased by more than 100% in the DHA-enriched phase, compared to other phases, demonstrating excellent dietary adherence.
Recruitment and retention strategies were effective in achieving a sufficient number of participants who completed the study protocol to enable sufficient statistical power to resolve small differences in outcome measures. It is expected that the study will generate important data thereby enhancing our understanding of the effects of n-3, n-6, and n-9 fatty acid-containing oils on CVD risks.
ClinicalTrials.gov NCT01351012.
菜籽油多中心干预试验(COMIT)是一项随机对照交叉研究,旨在评估五种提供不同油脂和/或油脂混合物的饮食对腹型肥胖个体心血管疾病(CVD)危险因素的影响。当前目标是报告腹型肥胖志愿者在食用富含n-3、n-6和n-9脂肪酸的饮食后血浆脂肪酸谱的初步研究结果。
COMIT在三个临床地点进行,分别是加拿大曼尼托巴省温尼伯市、加拿大魁北克省魁北克市以及美国宾夕法尼亚州大学公园市。纳入标准为以下至少一项:腰围(男性≥90厘米,女性≥84厘米),以及至少一项其他标准:甘油三酯≥1.7毫摩尔/升、高密度脂蛋白胆固醇<1毫摩尔/升(男性)或<1.3毫摩尔/升(女性)、血压≥130毫米汞柱(收缩压)和/或≥85毫米汞柱(舒张压)、血糖≥5.5毫摩尔/升。在五个为期30天的饮食阶段中,每个阶段都提供包含一种膳食油混合物奶昔的体重维持饮食。饮食阶段之间有四周的洗脱期。治疗用油为菜籽油、高油酸菜籽油、富含二十二碳六烯酸(DHA)的高油酸菜籽油、亚麻籽油和红花油混合物,以及玉米油和红花油混合物。决定采用按方案分析结合混合模型分析的方法进行数据分析。
170名志愿者被随机分组,130名完成了研究,脱落率为23.5%。作为依从性衡量指标,在所有参与者中分析的血浆总DHA浓度在富含DHA阶段比其他阶段增加了100%以上,表明饮食依从性良好。
招募和保留策略有效地获得了足够数量完成研究方案的参与者,从而有足够的统计效力来分辨结果测量中的微小差异。预计该研究将产生重要数据,从而增进我们对含n-3、n-6和n-9脂肪酸的油脂对心血管疾病风险影响的理解。
ClinicalTrials.gov NCT01351012。