Developing and Evaluating a Novel Food Supplement, Consisting of Canola Oil, Fibre and DHA, Aiming at the Management of CVD Risk in a Population With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in 10-year Framingham CVD risk score
研究概览
简要总结
The purpose of this study is to examine the effects of consumption of a novel food supplement consisting of Canola Oil, Fibre and DHA, containing the most effective food bioactives, including n-3 fatty acid enriched dietary oil high in monounsaturated fatty acids (MUFAs) and soluble dietary fibre, aiming at the management of heart disease risk factors in people with metabolic syndrome and to test its efficacy and safety in humans.
详细描述
The proposed study is a randomized, single-blind, crossover trial, it will be conducted at the Richardson Centre for Functional Food and Nutraceuticals (RCFFN), University of Manitoba. The study design will consist of 4 phases with 30 days per phase, each phase will be separated by 4-week washout periods. Participants will consume a recommended weight-maintaining diet (35% energy from fat, 50% carbohydrate, 15% protein) supplemented with the following novel Muffin and cookies: (a) control food containing butter, sunflower and safflower oil comprised largely of saturated fat with substantial levels of n-6 linoleic acid, and refined wheat flour common to current North American intakes, (b) food containing high oleic canola oil and docosahexaenoic acid (HOCO-DHA) and refined wheat flour, (c) food containing high molecular weight barley B-glucan and a combination of sunflower, safflower oil and butter, (d) food containing combination of HOCO-DHA and high molecular weight barley β-glucan. Treatments will be isocalorically incorporated into muffin and cookies consumed in equal parts at breakfast and supper.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI≥25 Kg/m2
- •Waist circumference ≥94 cm (males) or ≥80 cm (females)
- •Meet at least two of the following:
- •Triglycerides ≥1.7 mmol/L
- •High density lipoprotein (HDL) cholesterol <1 mmol/L (males) or <1.3 mmol/L (females)
- •Low density lipoprotein (LDL) cholesterol ≥2.7 mmol/L
- •Fasting glucose ≥5.6 mmol/L
排除标准
- •Consuming lipid lowering medications
- •Consuming nutritional supplements
- •Disease or disorder that could interfere with absorption
- •Hypertension ≥150 mmHg (systolic) and/or ≥100 mmHg (diastolic)
- •Planning to become pregnant
- •Consume >1 alcoholic drink/day
- •Medication within a month prior to screening
研究组 & 干预措施
Butter, sunflower and safflower oil
The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day)daily for 4 weeks.
干预措施: Butter, sunflower and safflower oil (Dietary Supplement)
High Oleic Canola Oil and DHA (HOCO-DHA)
The oil (50g/day) is given in muffin and cookies made with refined wheat flour (3 g/day) daily for 4 weeks.
干预措施: High Oleic Canola Oil and DHA (HOCO-DHA) (Dietary Supplement)
Barley Beta-glucan
The Barley beta-glucan (3 g/day) is given in muffin and cookies made with a combination of butter, sunflower and safflower oil (50 g/day) daily for 4 weeks.
干预措施: Barley beta-glucan (Dietary Supplement)
HOCO-DHA and Barley beta-glucan
The oil and beta-glucan (50g and 3g/day, respectively) is given in muffin and cookies daily for 4 weeks.
干预措施: HOCO-DHA and Barley beta-glucan (Dietary Supplement)
结局指标
主要结局
Change in 10-year Framingham CVD risk score
时间窗: The 10-year Framingham CVD risk score will be calculated for each participant at the end of each four 4-week treatment phases over a period of seven months
Change in 10-year Framingham CVD risk will be assessed using the multivariable Framingham risk equation.
次要结局
- Fasting plasma insulin concentration(Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months)
- Change in inflammatory markers(Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months)
- Change in body composition(Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months)
- Plasma and RBC fatty acid analysis(Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months)
- Change in blood lipid profile (TC, TG, LDL-C, HDL-C)(Blood samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months)
- Cholesterol synthesis rate(Fasting blood samples will be collected during the last 2 days of the four 4-week treatment phases over a period of seven months)
- Blood Pressure(Measurements will be done at the beginning and end of each of the four 4-week treatment phases over a period of seven months)
- Microbiome analysis(Fecal samples will be collected at the start and end of each of the four 4-week treatment phases over a period of seven months)