Impact of Haskalife(TM) Canadian Haskap Berry Powder Formulation on Hypertension and Acuity in Women's Health
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither the participants nor the investigators will know the allocation sequence or the identity of the powders.
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Haskap Berry Powder (Other)
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.
干预措施: Placebo Powder (Other)
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.
干预措施: Haskap Berry Powder (Other)
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.
干预措施: Placebo Powder (Other)
结局指标
主要结局
Systolic Blood Pressure
时间窗: Weeks 0, 6, 11, and 16
The participants' mean awake systolic blood pressure will be measured.
次要结局
- 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)