FREE Living Hulled HEMP Seed and Oil Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in red blood cell omega-3 fatty acid content
研究概览
简要总结
The objectives of this trial are to assess the effects of hemp product consumption, specifically hulled hemp seeds and hemp oil on blood fatty acid profiles and cardiovascular disease risk factors, in healthy overweight volunteers after 4 weeks of consumption.
详细描述
The trial will be a 4 week double-blinded, randomized, cross-over design with 2 treatment intervention (hemp and control) periods separated by a 4 week washout period. Thirty metabolically healthy overweight volunteers will be recruited into the trial.
On day 1, and 27, 28 of each treatment period participants will be asked to come to the Richardson Center for Functional Foods and Nutraceuticals (RCFFN) for a 12 hour fasted blood sample. On day 1, participants will be given prepackaged sachets of treatment hulled seeds (hemp or sesame) and salad dressing, containing 30 g/d of treatment (hemp or soybean) oil (in individually packaged daily containers) will also be supplied.
Participants will be instructed by clinical coordinators to integrate the products (2 sachets of seeds, 1 salad dressing) into their daily meals and to avoid other dietary sources of n-3 fatty acids, such as flax, chia, camelina, krill and fish products. Participants will be given activity monitors to wear during the intervention periods. Participants will be required to eat one sachet of hulled seeds in the morning and one in the evening, and to consume the dressing throughout the day, for each 4 week treatment period.
Participants will be asked to continue their habitual diets, while avoiding large dietary sources of n-3 fatty acids, throughout the treatment and washout periods. Participants will be instructed to maintain the same level of physical activity and alcohol intake throughout the trial period. The trial coordinator will contact participants weekly via telephone or email to monitor treatment adherence and to answer any questions or concerns participants might have. Background dietary intakes will be measured at day 1 of the trial using a food frequency questionnaire, and during each treatment period by 3-day food record to be completed in the last week of each treatment period. Participants will be asked questions about the interventions including side effects, mood and perceived energy level by trial coordinators at the end of each intervention period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Metabolically healthy overweight (BMI 25-35 kg/m2) participants aged 18-65,
- •Men and women with the ability to give written informed consent and comply with trial guidelines.
排除标准
- •Pregnancy or lactation
- •Smokers (tobacco products for the last 6 months)
- •History of cancer, rheumatoid arthritis, chronic illness, cardiovascular problems, liver and kidney disease, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease, neurological/psychological disease, bleeding disorders, experienced platelet abnormalities, and gastrointestinal disorders that could interfere with fat absorption, serum glucose over ≥6.1 mmol/L, serum triglycerides (TG) >4.52 mmol/L, and/or LDL cholesterol (LDL-C) ≥6.5 mmol/L, hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg),
- •Body mass index (BMI; in kg/m2) ≥35
- •Consume or plan to consume anticoagulant,
- •Hypertension or lipid lowering medications, or hypotensive
- •Lipid lowering or n-3 PUFA dietary supplements
- •Reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence
- •Reported use of any experimental medication within 1 month prior to starting the trial.
结局指标
主要结局
Change in red blood cell omega-3 fatty acid content
时间窗: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Total lipids will be extracted from each fraction (whole plasma, RBC) and will be evaluated for its fatty acid composition using gas-chromatography linked with flame ionization detector
次要结局
- Change in plasma lipids(Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period)
- Change in inflammatory and endothelial function biomarkers(Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period)
- Change in blood pressure and arterial stiffness(Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period)
- Change in glucose metabolism and insulin sensitivity(Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period)