OverweightFREEHEMPNCT02400203
FREE Living Hulled HEMP Seed and Oil Trial
A study testing Hemp foods in people with Overweight, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Hemp foods
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2015to Sep 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
Winnipeg, Manitoba, R3T 6C5
About this study
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.
Read the 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.
- Conditions
- Overweight
- Being tested
- Control, Hemp foods
- Keywords
- hemp oil,, hemp, fatty acids, omega-6, omega-3, blood pressure, blood lipids
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlOther
Hemp foodsOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | 54 grams of hulled sesame seeds, consumed in 2 daily 27 gram portions, and 30 grams of soybean oil per day Receives: Other: Control |
| Hemp foods | Experimental | 60 grams of hulled hemp seeds,consumed in 2 daily 30 gram portions, and 30 grams of hemp oil per day Receives: Other: Hemp foods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rotimi Aluko, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02400203
- Sponsor's protocol ID
- B2014:115-2
- Acronym
- FREEHEMP
- Status last verified
- Apr 2021
- First submitted
- 23 Mar 2015
- Last updated
- 23 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
She Y, Jia K, Cardillo A, Shamloo M, Leon AS, Liu X, Mollard R, Mackay DS. The effect of hemp product consumption on blood fatty acid profiles and cardiovascular disease risk factors: results of a randomized, double-blind, crossover clinical trial. Food Funct. 2026 Mar 23;17(6):2884-2892. doi: 10.1039/d5fo04672f.
PubMed 41782552
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FREE Living Hulled HEMP Seed and Oil Trial
- ClinicalTrials.gov ID
- NCT02400203
- Acronym / sponsor ID
- FREEHEMP / B2014:115-2
- Conditions
- Overweight
- Keywords
- hemp oil,, hemp, fatty acids, omega-6, omega-3, blood pressure, blood lipids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Control54 grams of hulled sesame seeds, consumed in 2 daily 27 gram portions, and 30 grams of soybean oil per day |
| Hemp foods | Experimental | Other: Hemp foods60 grams of hulled hemp seeds,consumed in 2 daily 30 gram portions, and 30 grams of hemp oil per day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (9 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Control | Other | Control |
| Hemp foods | Other | Hemp foods |
Primary outcome
Change in red blood cell omega-3 fatty acid content
Time frame: 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
4 secondary outcomes
Change in plasma lipids
Time frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Change in inflammatory and endothelial function biomarkers
Time frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Change in blood pressure and arterial stiffness
Time frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Change in glucose metabolism and insulin sensitivity
Time frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2023.
- Derived from this study: PubMed 41782552She Y, Jia K, Cardillo A, Shamloo M, Leon AS, Liu X, Mollard R, Mackay DS. The effect of hemp product consumption on blood fatty acid profiles and cardiovascular disease risk factors: results of a randomized, double-blind, crossover clinical trial. Food Funct. 2026 Mar 23;17(6):2884-2892. doi: 10.1039/d5fo04672f.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rotimi Aluko, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemp foods in people with Overweight, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in red blood cell omega-3 fatty acid content (time frame: Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02400203, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2023.