Impact of Canadian Haskap Berry Powder on Hypertension and Acuity in Women's Health

Not Applicable

Not yet recruiting

• Conditions: Hypertension; Alertness

• Registration Number: NCT06764121
• Lead Sponsor: University of Manitoba

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2025-01-02
• Study First Submitted QC: 2025-01-02
• Study First Posted: 2025-03-25
• Study Start: 2025-03-28
• Last Update Submitted: 2025-03-31
• Last Update Posted: 2025-04-03
• Primary Completion: 2026-01-06
• Study Completion: 2026-07-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	Weeks 0, 6, 11, and 16	The participants' mean awake systolic blood pressure will be measured.

Secondary Outcome Measures

Name	Time	Method
Reaction Time	Weeks 0, 6, 11, and 16	Mean reaction time to a series of visual stimuli.
Memory	Weeks 0, 6, 11, and 16	Rey Auditory Verbal Learning Test score
Diastolic Blood Pressure	Weeks 0, 6, 11, and 16	Mean awake diastolic blood pressure over 3 days
Systolic and Diastolic Blood Pressure	Weeks 0, 6, 11, and 16.	Mean systolic and diastolic blood pressure measured over three days.
Heart Rate	Weeks 0, 6, 11, and 16	Mean heart rate measured over three days.

Trial Locations

Locations (1)

Richardson Centre for Food Technology and Research; 🇨🇦 Winnipeg, Manitoba, Canada