- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06764121
Impact of Canadian Haskap Berry Powder on Hypertension and Acuity in Women's Health
Impact of Haskalife(TM) Canadian Haskap Berry Powder Formulation on Hypertension and Acuity in Women's Health
Haskap berries are rich in cyanidin-3-O-glucoside (C3G), which has been shown in vitro to enhance endothelial function. Previous clinical studies suggest haskap berry supplementation may improve cognition, mood, blood pressure, and athletic performance, but research is limited. This trial aims to contribute to the growing body of evidence on the effects of haskap berry supplementation.
The trial is a 2-period, randomized, double-blinded, cross-over design lasting 16 weeks. During the first period (weeks 0-6), participants will receive either haskap berry powder or a control powder. A 4-week washout period follows (weeks 7-10), where no powder is consumed. In the second period (weeks 11-16), participants will receive the powder they did not consume in the first period.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3T 2N2
- Richardson Centre for Food Technology and Research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Willing and able to provide informed consent to participate in the trial;
- Biological female who is at least 35 years of age;
- A waist circumference of at least 35 inches;
- Average systolic blood pressure between 120 and 150 mmHg;
- Average diastolic blood pressure between 75 and 100 mmHg
Exclusion Criteria:
- Biological male;
- Gluten allergies, celiac disease, or gluten intolerance;
- Allergic to berries;
- Receiving chemotherapy;
- Use of medications containing pseudoephedrine or other anti-inflammatory drugs, and the use of cyclosporine or tacrolimusin;
- Cardiovascular diseases including stroke, congestive heart failure, myocardial infarction, unstable angina pectoris, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, and transient ischemic attack within six months before screening;
- Inability to consume treatment product;
- Inability to provide written informed consent;
- Any of the following visual impairments: diabetic retinopathy, age-related macular degeneration, glaucoma, or cataract;
- Risk of epileptic seizures;
- Any form of motor impairments;
- Any visual impairments, uncorrected vision problems, eye disorders, or injuries
- Any medical condition, uncontrolled systemic disease, or concurrent illness that would hinder study compliance or jeopardize the participant's safety, based on the investigator's opinion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Haskap Powder then Control Powder
The participants will consume the haskap powder between weeks 0 and 6.
A washout period will occur between weeks 7 and 10.
After the washout period, the participants will consume the control powder between weeks 11 and 16.
None of the participants or investigators will know the identities of the powder or the participants' allocations.
|
The participants will consume four packets (16g) of haskap berry powder.
The powder can be consumed with other food products.
The participants will consume four packets (24g) of placebo powder.
The powder can be consumed with other food products.
|
|
Experimental: Control Powder then Haskap Powder.
The participants will consume the control powder between weeks 0 and 6.
A washout period will occur between weeks 7 and 10.
After the washout period, the participants will consume the haskap powder between weeks 11 and 16.
None of the participants or investigators will know the identities of the powder or the participants' allocations.
|
The participants will consume four packets (16g) of haskap berry powder.
The powder can be consumed with other food products.
The participants will consume four packets (24g) of placebo powder.
The powder can be consumed with other food products.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic Blood Pressure
Time Frame: Weeks 0, 6, 11, and 16
|
The participants' mean awake systolic blood pressure will be measured.
|
Weeks 0, 6, 11, and 16
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reaction Time
Time Frame: Weeks 0, 6, 11, and 16
|
Mean reaction time to a series of visual stimuli.
|
Weeks 0, 6, 11, and 16
|
|
Diastolic Blood Pressure
Time Frame: Weeks 0, 6, 11, and 16
|
Mean awake diastolic blood pressure over 3 days
|
Weeks 0, 6, 11, and 16
|
|
Systolic and Diastolic Blood Pressure
Time Frame: Weeks 0, 6, 11, and 16.
|
Mean systolic and diastolic blood pressure measured over three days.
|
Weeks 0, 6, 11, and 16.
|
|
Heart Rate
Time Frame: Weeks 0, 6, 11, and 16
|
Mean heart rate measured over three days.
|
Weeks 0, 6, 11, and 16
|
|
Memory
Time Frame: Weeks 0, 6, 11, and 16
|
Rey Auditory Verbal Learning Test score
|
Weeks 0, 6, 11, and 16
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Clinical Chemistry
Time Frame: Weeks 0, 6, 11, and 16
|
Blood Urea Nitrogen, cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, fasting blood glucose, creatinine, creatine, albumin, alanine transaminase, and aspartate amino transferase
|
Weeks 0, 6, 11, and 16
|
|
Nutritional Intake
Time Frame: Three days before (1) week 0, (2) week 6, (3) week 11, and (4) week 16
|
Total calories, carbohydrates, fat, and protein
|
Three days before (1) week 0, (2) week 6, (3) week 11, and (4) week 16
|
|
Acceptability
Time Frame: Weeks 6 and 16
|
Overall acceptability of the powder via feedback questionnaire
|
Weeks 6 and 16
|
|
Weight and waist circumference
Time Frame: Weeks 0, 6, 11, and 16
|
Weight (kg) and waist circumference ( inches) will be measured.
|
Weeks 0, 6, 11, and 16
|
|
Physical Activity
Time Frame: Weeks 0, 6, 11, and 16
|
The time spent doing (1) vigorous activities, (2) moderate activities, (3) walking, and (4) sedentary activities.
|
Weeks 0, 6, 11, and 16
|
|
Energy and Mood
Time Frame: Weeks 0, 6, 11, and 16
|
Visual analog scale to measure energy and mood
|
Weeks 0, 6, 11, and 16
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Semone Myrie, PhD, University of Manitoba
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS26475 (B2024:057)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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