NCT06393621已完成不适用
Prospective, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Investigate the Effectiveness of KEFPEP® on Regulating High Blood Pressure
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Reduction of 5 mmHg SBP
研究概览
简要总结
To assess the ability of KEFPEP® to reduce blood pressure
详细描述
Primary objective-
• To assess the ability of KEFPEP® to reduce blood pressure.
Secondary objective-
- To access the effect of KEFPEP® on vascular inflammation or damage.
- To access the effect of KEFPEP® on cardiovascular diseases prevention.
- To assess the safety of KEFPEP® .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patient ages 20 years or older.
- •Belong to either one of the following categories based on the Seventh Report of the Joint National Committee (JNC 7) as measured by office BP at Screening visit:
- •Prehypertension (SBP 120 - 139 mmHg or DBP 80 - 89 mmHg)
- •Stage I hypertension (SBP 140 - 159 mmHg or DBP 90 - 99 mmHg)
- •Body weight≤90 kg, and BMI≥18.5 kg/m2 or < 30 kg/m
- •NOT on any antihypertensive treatment at the time of entry into the study.
- •Willing to comply with the study procedures and follow-ups.
- •Understand the nature of the study, and have signed informed consent forms.
排除标准
- •Patients with any of the following conditions within 6 months prior to study participation:
- •Secondary hypertension
- •Uncontrolled diabetes mellitus
- •Renal disease based on the investigator's judgment
- •Severe hepatic disease with Child-Pugh class C
- •Severe anaemia
- •Any malignant disease or serious disease
- •Patients with clinically significant abnormalities in the following laboratory parameters within 2 weeks prior to Screening visit or during the screening period:
- •HbA1c > 9%
- •AST or ALT ≥ 3 x upper limit of normal (ULN)
- •Estimated glomerular filtration rate (eGFR) < 50 ml/min/1.73 m2
- •Serum creatinine ≥ 3 x ULN
- •Hemoglobin < 10 g/dL
- •History of milk allergy and/or lactose intolerance.
- •History of alcohol abuse.
- •Constant use of oral medication or supplements affecting blood pressure.
- •Female patients who are pregnant, planning to become pregnant, or lactating.
- •Male or female patients of child-bearing potential do not agree to use an effective method of contraception during the study period.
- •Currently participating in any other interventional clinical study within 30 days
- •Patients who are considered not suitable for the study according to the investigator's judgment for the patient's best interest.
研究组 & 干预措施
KEFPEP®
Experimental
- Dosage form: Powder (directly take the powder with appropriate amount of warm water)
- Dose(s): Total 2.8 g kefir-fermented milk powder with increased peptide content 1.2 g.
干预措施: KEFPEP® (Dietary Supplement)
Placebo
Placebo Comparator
- Dosage form: Powder (directly take the powder with appropriate amount of warm water).
- Dose(s): Total 2.8 g starch power.
干预措施: Placebo (Other)
结局指标
主要结局
Reduction of 5 mmHg SBP
时间窗: At week 12
I. Reduction of 5 mmHg from Baseline in office SBP. II. Reduction of 5 mmHg from Baseline in 24-hour ambulatory SBP.
Reduction of 10 mmHg SBP
时间窗: At week 12
I. Reduction of 10 mmHg from Baseline in office SBP. II. Reduction of 10 mmHg from Baseline in 24-hour ambulatory SBP.
次要结局
- Biomarkers of blood vessel damage(Baseline (Day 1/Visit 3) and Week 12 (Visit 6))
- Follow-up and safety analyses -Adverse events (AEs)(The 2-week follow-up period once completing the 12-week dietary)
- Office SBP and diastolic blood pressure (DBP)(Baseline (Day 1/Visit 3), Week 4 (Visit 4), Week 8 (Visit 5), and Week 12 (Visit 6))
- 24-hour ambulatory(Baseline (Day 1/Visit 3) and Week 12 (Visit 6))
- Biomarkers of blood vessel inflammation(Baseline (Day 1/Visit 3) and Week 12 (Visit 6))
- Follow-up and safety analyses -Vital signs(The 2-week follow-up period once completing the 12-week dietary)
研究者
Chuan -Mu Chen
Chair Professor
National Chung Hsing University
研究点 (1)
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