Clinical trial NCT06764121: Impact of Canadian Haskap Berry Powder on Hypertension and Acuity in Women's Health
Official title: Impact of Haskalife(TM) Canadian Haskap Berry Powder Formulation on Hypertension and Acuity in Women's Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Alertness
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 32
Sex: FEMALE
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The trial will be a 2-period randomized, double-blinded, cross-over study that will last for 16 weeks.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Systolic Blood Pressure
timeFrame: Weeks 0, 6, 11, and 16
Secondary outcomes:
measure: Reaction Time
timeFrame: Weeks 0, 6, 11, and 16
measure: Memory
timeFrame: Weeks 0, 6, 11, and 16
measure: Diastolic Blood Pressure
timeFrame: Weeks 0, 6, 11, and 16
measure: Systolic and Diastolic Blood Pressure
timeFrame: Weeks 0, 6, 11, and 16.
measure: Heart Rate
timeFrame: Weeks 0, 6, 11, and 16
Other outcomes:
measure: Acceptability
timeFrame: Weeks 6 and 16
measure: Clinical Chemistry
timeFrame: Weeks 0, 6, 11, and 16
measure: Weight and waist circumference
timeFrame: Weeks 0, 6, 11, and 16
measure: Nutritional Intake
timeFrame: Three days before (1) week 0, (2) week 6, (3) week 11, and (4) week 16
measure: Physical Activity
timeFrame: Weeks 0, 6, 11, and 16
measure: Energy and Mood
timeFrame: Weeks 0, 6, 11, and 16
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Food Technology and Research
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Semone Myrie, PhD
role: PRINCIPAL_INVESTIGATOR
References: