Effect of Oligopin® on Blood Pressure.
키워드
요약
날짜
| 마지막 확인: | 02/28/2015 |
| 처음 제출: | 02/12/2014 |
| 제출 된 예상 등록: | 02/12/2014 |
| 처음 게시 됨: | 02/13/2014 |
| 제출 된 마지막 업데이트: | 03/16/2015 |
| 마지막 업데이트 게시: | 03/17/2015 |
| 실제 연구 시작 날짜: | 10/31/2013 |
| 예상 기본 완료 날짜: | 10/31/2014 |
| 예상 연구 완료 날짜: | 12/31/2014 |
상태 또는 질병
개입 / 치료
Dietary Supplement: Product one
Dietary Supplement: Product two
단계
팔 그룹
| 팔 | 개입 / 치료 |
|---|---|
| Placebo Comparator: Product one 150 mg (maltodextrin)/day (75 mg maltodextrin included in 280 mg/gelule; 2 times/day: morning and evening) of Placebo plus Dietary Approaches to Stop Hypertension (DASH) | Dietary Supplement: Product one The placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule |
| Active Comparator: Product two 150 mg Oligopin/day (75mg Oligopin included in 280mg/gelule; 2 times/day: morning and evening) of Oligopin® plus Dietary Approaches to Stop Hypertension (DASH) | Dietary Supplement: Product two Oligopin® PUR' expert (%) is a red brown powder extracted from the bark of the Maritime Pine (Pinus pinaster) with composition:
- TOTAL POLYPHENOL CONTENT > 96
MONOMERS + PHENOLIC ACIDS 30
DIMERS >15
OTHER OLIGOMERS 50
PROCYANIDINS CONTENT (GPC) > 67
The Oligopin composition is for 1 gelule: 75 mg Oligopin + 175 mg maltodextrine + 30 mg magnesium stearate: total weight: 280 mg/gelule |
자격 기준
| 공부할 수있는 연령 | 18 Years 에 18 Years |
| 공부할 수있는 성별 | All |
| 건강한 자원 봉사자를 받아들입니다 | 예 |
| 기준 | Inclusion Criteria: - early stages of hypertension (systolic BP ≥ 140 and ≤ 159 mm Hg) and/or diastolic BP: ≥ 90 and ≤ 99 mm Hg - not receiving BP-lowering medication. - obtained written informed consent before the initial screening visit. Exclusion Criteria: - Body Mass Index (BMI) > 30 kg/m2 - taking antihypertensive medications - smoking - pregnant or who intends to become pregnant - wife in breastfeeding period - persons with a self-reported history of clinical cardiovascular disease, cancer, chronic kidney disease (or a serum creatinine ≥ 1.7 mg/dL for men and ≥ 1.5 mg/dL for women) hypercholesterolemia (LDL-c ≤ 189 mg/dL, diabetes mellitus (or serum glucose ≥126 mg/dL), or consumption of more than 14 drinks of alcoholic beverages per week. |
결과
1 차 결과 측정
1. Differences detected on the time evolution of BP both in two arms of intervention [5 weeks]
2 차 결과 측정
1. Anthropometric data (Weight, BMI, Waist circumference) [weeks 2, 5, 6, 9]
2. Endothelial function (Laser-Doppler) [Weeks 2, 5, 6, 9]
3. Biochemistry for on-going study control (Glucose, Total cholesterol levels, Creatinine, Albumine, Transaminases (GPT, GOT) [Week 1]
4. - Biomarkers related with endothelial function (Endotheline-1, Nitrites (NO3), Nitrates (NO2)) - Biomarker related with blood pressure homeostasis (ACE activity) [Weeks 2, 5, 6, 9]
5. - Biomarker related with inflammatory processes (High sensitive C Reactive Protein) - Biomarkers of antioxidant system (Oxidised- LDL levels, Reduced glutathione, Oxidised glutathione, Ratio Glutathione balance) [Weeks 2, 5, 6, 9]
