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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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30 January 2023 |
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Main ID: |
NCT02400203 |
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Date of registration:
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23/03/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FREE Living Hulled HEMP Seed and Oil Trial
FREEHEMP |
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Scientific title:
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FREE Living Hulled HEMP Seed and Oil Trial |
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Date of first enrolment:
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August 2015 |
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Target sample size:
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30 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02400203 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Canada
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Contacts
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Name:
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Rotimi Aluko, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Manitoba |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Overweight
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Intervention(s)
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Other: Control
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Other: Hemp foods
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Primary Outcome(s)
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Change in red blood cell omega-3 fatty acid content
[Time Frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
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Secondary Outcome(s)
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Change in plasma lipids
[Time Frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
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Change in blood pressure and arterial stiffness
[Time Frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
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Change in glucose metabolism and insulin sensitivity
[Time Frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
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Change in inflammatory and endothelial function biomarkers
[Time Frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period]
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Secondary ID(s)
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B2014:115-2
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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