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

NCT06764121 | Active Not Recruiting

• 1 other identifier: HS26475 (B2024:057)
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  The participants' mean awake systolic blood pressure will be measured.

  Weeks 0, 6, 11, and 16

Secondary Outcomes (5)

• Reaction Time

  Weeks 0, 6, 11, and 16

• Memory

  Weeks 0, 6, 11, and 16

• Diastolic Blood Pressure

  Weeks 0, 6, 11, and 16

• Systolic and Diastolic Blood Pressure

  Weeks 0, 6, 11, and 16.

• Heart Rate

  Weeks 0, 6, 11, and 16

Other Outcomes (6)

• Acceptability

  Weeks 6 and 16

• Clinical Chemistry

  Weeks 0, 6, 11, and 16

• Weight and waist circumference

  Weeks 0, 6, 11, and 16

Study Arms (2)

Haskap Powder then Control Powder

EXPERIMENTAL

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.

Other: Haskap Berry Powder; Other: Placebo Powder

Control Powder then Haskap Powder.

EXPERIMENTAL

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.

Other: Haskap Berry Powder; Other: Placebo Powder

Interventions

Haskap Berry Powder OTHER

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

Control Powder then Haskap Powder.; Haskap Powder then Control Powder

Placebo Powder 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.; Haskap Powder then Control Powder

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Richardson Centre for Food Technology and Research

Winnipeg, Manitoba, R3T 2N2, Canada

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Semone Myrie, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Neither the participants nor the investigators will know the allocation sequence or the identity of the powders.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The trial will be a 2-period randomized, double-blinded, cross-over study that will last for 16 weeks.

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: April 3, 2025
• Primary Completion: March 26, 2026
• Study Completion (Estimated): August 6, 2026
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)