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

NCT ID: NCT06764121

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-03
• Study Completion Date: 2026-08-06

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.

Conditions

Hypertension; Alertness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Haskap Berry Powder

Intervention Type: OTHER

The participants will consume four packets (16g) of haskap berry powder. The powder can be consumed with other food products.

Placebo Powder

Intervention Type: OTHER

The participants will consume four packets (24g) of placebo powder. The powder can be consumed with other food products.

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.

Group Type: EXPERIMENTAL

Haskap Berry Powder

Intervention Type: OTHER

The participants will consume four packets (16g) of haskap berry powder. The powder can be consumed with other food products.

Placebo Powder

Intervention Type: OTHER

The participants will consume four packets (24g) of placebo powder. The powder can be consumed with other food products.

Interventions

Haskap Berry Powder

The participants will consume four packets (16g) of haskap berry powder. The powder can be consumed with other food products.

Intervention Type: OTHER

Placebo Powder

The participants will consume four packets (24g) of placebo powder. The powder can be consumed with other food products.

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Semone Myrie, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Richardson Centre for Food Technology and Research

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

HS26475 (B2024:057)

Identifier Type: -

Identifier Source: org_study_id