FREE Living Hulled HEMP Seed and Oil Trial

NCT ID: NCT02400203

Last Updated: 2023-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2017-09-30

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.

Conditions

Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Control

54 grams of hulled sesame seeds, consumed in 2 daily 27 gram portions, and 30 grams of soybean oil per day

Group Type: ACTIVE_COMPARATOR

Control

Intervention Type: OTHER

Hemp foods

60 grams of hulled hemp seeds,consumed in 2 daily 30 gram portions, and 30 grams of hemp oil per day

Group Type: EXPERIMENTAL

Hemp foods

Intervention Type: OTHER

Interventions

Control

Intervention Type: OTHER

Hemp foods

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rotimi Aluko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2014:115-2

Identifier Type: -

Identifier Source: org_study_id