FREE Living Hulled HEMP Seed and Oil Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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FREE Living Hulled HEMP Seed and Oil Trial

Conditions
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Overweight

Intervention / Treatment
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* Other: Control
* Other: Hemp foods


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>54 grams of hulled sesame seeds, consumed in 2 daily 27 gram portions, and 30 grams of soybean oil per day | Other: Control<br> <br> |
| Experimental: Hemp foods<br>60 grams of hulled hemp seeds,consumed in 2 daily 30 gram portions, and 30 grams of hemp oil per day | Other: Hemp foods<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in red blood cell omega-3 fatty acid content | 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 | Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma lipids | TC, HDL-C and TG in serum, will be determined by automated methods in duplicate on an auto-analyzer (VITROS 350). LDL-C concentrations will be calculated using the Friedewald equation. | Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period | 
| Change in inflammatory and endothelial function biomarkers | Measurement of inflammatory biomarker such as CRP, IL-6 and TNF-α and cell adhesion molecules such as e-selectin, p-selectin, s-ICAM and s-VCAM, will be measured in multiplex on a Meso Scale Discovery platform. | Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period | 
| Change in blood pressure and arterial stiffness | Blood pressure will be measure in conjunction with pulse wave velocity (PWV) and augmentation index (AI) to assess arterial stiffness using a Mobil-O-Graph, in triplicate. | Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period | 
| Change in glucose metabolism and insulin sensitivity | Measurement of fasting glucose using an auto-analyzer, and insulin by radioimmunoassay, to investigate the impact of hemp product consumption on glucose metabolism and insulin sensitivity. | Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemp oil,, hemp, fatty acids, omega-6, omega-3, blood pressure, blood lipids