FREE Living Hulled HEMP Seed and Oil Trial

Overweight Clinical Trial

— FREEHEMP  

Official title:

FREE Living Hulled HEMP Seed and Oil Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400203
• Other study ID #: B2014:115-2
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2017

Study information

• Verified date: April 2021
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Overweight

Intervention

Other:
• Control

• Hemp foods

Locations

Country	Name	City	State
Canada	Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in body composition	Using a Dual Energy X-Ray Absorptiometry machine to analyze body composition, including measuring visceral adiposity	Measurements will be done at the beginning and end of each of the two 4-week treatment
Other	Physical activity	The activity monitors will measure the participants' physical activity levels, steps taken, and the different amounts of time spent at different activity levels.	from day 20-28 of each treatment period
Primary	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	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
Secondary	Change in inflammatory and endothelial function biomarkers	Measurement of inflammatory biomarker such as CRP, IL-6 and TNF-a 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
Secondary	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
Secondary	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