Clinical trial NCT02400203: FREE Living Hulled HEMP Seed and Oil Trial
Official title: FREE Living Hulled HEMP Seed and Oil Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Keywords: hemp oil,
hemp
fatty acids
omega-6
omega-3
blood pressure
blood lipids
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in red blood cell omega-3 fatty acid content
timeFrame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Secondary outcomes:
measure: Change in plasma lipids
timeFrame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
measure: Change in inflammatory and endothelial function biomarkers
timeFrame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
measure: Change in blood pressure and arterial stiffness
timeFrame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
measure: Change in glucose metabolism and insulin sensitivity
timeFrame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Other outcomes:
measure: Change in body composition
timeFrame: Measurements will be done at the beginning and end of each of the two 4-week treatment
measure: Physical activity
timeFrame: from day 20-28 of each treatment period
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Rotimi Aluko, PhD
role: PRINCIPAL_INVESTIGATOR
References: