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

University of Manitoba

Status: Not yet enrolling

Conditions: Hypertension; Alertness

Treatments: Other: Placebo Powder; Other: Haskap Berry Powder

Study type: Interventional

Funder types: Other

Identifiers

NCT06764121

HS26475 (B2024:057)

Details and patient eligibility

About

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.

Enrollment: 32 estimated patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Haskap Powder then Control Powder

Experimental group

Description:

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.

Treatment:

Other: Haskap Berry Powder

Other: Placebo Powder

Control Powder then Haskap Powder.

Experimental group

Description:

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.

Treatment:

Other: Haskap Berry Powder

Other: Placebo Powder