FREE Living Hulled HEMP Seed and Oil Trial
关键词
抽象
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.
日期
| 最后验证: | 08/31/2017 |
| 首次提交: | 03/22/2015 |
| 提交的预估入学人数: | 03/24/2015 |
| 首次发布: | 03/25/2015 |
| 上次提交的更新: | 01/22/2020 |
| 最近更新发布: | 01/26/2020 |
| 实际学习开始日期: | 07/31/2015 |
| 预计主要完成日期: | 01/31/2016 |
| 预计完成日期: | 08/31/2017 |
状况或疾病
干预/治疗
Other: Control
Other: Hemp foods
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: Control 54 grams of hulled sesame seeds, consumed in 2 daily 27 gram portions, and 30 grams of soybean oil per day | Other: Control |
| Experimental: Hemp foods 60 grams of hulled hemp seeds,consumed in 2 daily 30 gram portions, and 30 grams of hemp oil per day | Other: Hemp foods |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
结果
主要结果指标
1. Change in red blood cell omega-3 fatty acid content [Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
次要成果指标
1. Change in plasma lipids [Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
2. Change in inflammatory and endothelial function biomarkers [Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
3. Change in blood pressure and arterial stiffness [Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
4. Change in glucose metabolism and insulin sensitivity [Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
其他成果措施
1. Change in body composition [Measurements will be done at the beginning and end of each of the two 4-week treatment]
2. Physical activity [from day 20-28 of each treatment period]
