Alertness, Hypertension
Conditions
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.
Interventions
OTHERHaskap Berry Powder
The participants will consume four packets (16g) of haskap berry powder. The powder can be consumed with other food products.
OTHERPlacebo Powder
The participants will consume four packets (24g) of placebo powder. The powder can be consumed with other food products.
Sponsors
University of Manitoba
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Neither the participants nor the investigators will know the allocation sequence or the identity of the powders.
Intervention model description
The trial will be a 2-period randomized, double-blinded, cross-over study that will last for 16 weeks.
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | Weeks 0, 6, 11, and 16 | The participants' mean awake systolic blood pressure will be measured. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | Weeks 6 and 16 | Overall acceptability of the powder via feedback questionnaire |
| Clinical Chemistry | 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 |
| Weight and waist circumference | Weeks 0, 6, 11, and 16 | Weight (kg) and waist circumference ( inches) will be measured. |
| Nutritional Intake | Three days before (1) week 0, (2) week 6, (3) week 11, and (4) week 16 | Total calories, carbohydrates, fat, and protein |
| Physical Activity | Weeks 0, 6, 11, and 16 | The time spent doing (1) vigorous activities, (2) moderate activities, (3) walking, and (4) sedentary activities. |
| Energy and Mood | Weeks 0, 6, 11, and 16 | Visual analog scale to measure energy and mood |
Countries
Canada
Outcome results
None listed