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NCT Number: NCT06764121

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Hypertension Alertness Cardiovascular Diseases Vascular Diseases

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Richardson Centre for Food Technology and Research

Winnipeg, Manitoba, R3T 2N2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haskap Berry Powder

Other

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

Placebo Powder

Other

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

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: Weeks 0, 6, 11, and 16

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

Secondary outcomes

  1. Reaction Time

    Time frame: Weeks 0, 6, 11, and 16

    Mean reaction time to a series of visual stimuli.

  2. Memory

    Time frame: Weeks 0, 6, 11, and 16

    Rey Auditory Verbal Learning Test score

  3. Diastolic Blood Pressure

    Time frame: Weeks 0, 6, 11, and 16

    Mean awake diastolic blood pressure over 3 days

  4. Systolic and Diastolic Blood Pressure

    Time frame: Weeks 0, 6, 11, and 16.

    Mean systolic and diastolic blood pressure measured over three days.

  5. Heart Rate

    Time frame: Weeks 0, 6, 11, and 16

    Mean heart rate measured over three days.

Other outcomes

  1. Acceptability

    Time frame: Weeks 6 and 16

    Overall acceptability of the powder via feedback questionnaire

  2. Clinical Chemistry

    Time frame: Weeks 0, 6, 11, and 16

    Blood Urea Nitrogen, cholesterol, triglycerides, high-density lipoprotein, low-density lipoprotein, fasting blood glucose, creatinine, creatine, albumin, alanine transaminase, and aspartate amino transferase

  3. Weight and waist circumference

    Time frame: Weeks 0, 6, 11, and 16

    Weight (kg) and waist circumference ( inches) will be measured.

  4. Nutritional Intake

    Time frame: Three days before (1) week 0, (2) week 6, (3) week 11, and (4) week 16

    Total calories, carbohydrates, fat, and protein

  5. Physical Activity

    Time frame: Weeks 0, 6, 11, and 16

    The time spent doing (1) vigorous activities, (2) moderate activities, (3) walking, and (4) sedentary activities.

  6. Energy and Mood

    Time frame: Weeks 0, 6, 11, and 16

    Visual analog scale to measure energy and mood

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Registry information

Official study title

Impact of Haskalife(TM) Canadian Haskap Berry Powder Formulation on Hypertension and Acuity in Women's Health

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 8, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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