NCT02400203

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

January 23, 2023

Status Verified

April 1, 2021

Enrollment Period

6 months

First QC Date

March 23, 2015

Last Update Submit

January 19, 2023

Conditions

Overweight

Keywords

hemp oil,hempfatty acidsomega-6omega-3blood pressureblood lipids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in plasma lipids

    Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period

  • Change in inflammatory and endothelial function biomarkers

    Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period

  • Change in blood pressure and arterial stiffness

    Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period

  • Change in glucose metabolism and insulin sensitivity

    Baseline (Day 1) and Endpoint (Day 27,28) of each experimental period

Other Outcomes (2)

  • Change in body composition

    Measurements will be done at the beginning and end of each of the two 4-week treatment

  • Physical activity

    from day 20-28 of each treatment period

Study Arms (2)

Control

ACTIVE COMPARATOR

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

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

Other: Hemp foods

Interventions

ControlOTHER
Control
Hemp foodsOTHER
Hemp foods

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba

Winnipeg, Manitoba, R3T 6C5, Canada

Location

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Rotimi Aluko, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

August 1, 2015

Primary Completion

February 1, 2016

Study Completion

September 1, 2017

Last Updated

January 23, 2023

Record last verified: 2021-04

Locations

CA(1)