The Effects of Milk Proteins on Blood Pressure
The primary purpose of the study is to demonstrate a blood pressure lowering effect of CasiGold and CasiMax in subjects with high-normal blood pressure or mild hypertension. The secondary purpose is to collect human safety data after treatment with CasiGold and CasiMax, to gain insight into potential mechanisms by measurement of renin and angiotensin I and II, and to evaluate the genetic determinants of the individual BP lowering response by measurement of specific genetic polymorphisms.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||The Effects of Casigold and Casimax on Blood Pressure in Subjects With Highnormal Blood Pressure or Mild Hypertension|
- Blood pressure [ Time Frame: 4 weeks ]
- Safety data in blood and urine [ Time Frame: 4 weeks ]
- Genetic determinants of the individual BP lowering response by measurement of specific genetic polymorphisms. [ Time Frame: once during the study ]
- Potential mechanisms by measurement of renin and angiotensin I and II (only be done in case a change in BP is found). [ Time Frame: 4 weeks ]
|Study Start Date:||May 2007|
|Study Completion Date:||February 2008|
Rationale: Hypertension is the major controllable risk factor associated with cardiovascular disease. The risk of developing CVD is directly related to blood pressure (BP) level. Tripeptides IPP and VPP obtained from milk proteins were shown to have potential blood lowering effects. The renin-angiotensin system is one of the major pathways of BP regulation, and ACE inhibition is an important target for BP control. CasiGold and CasiMax are hydrolysed casein preparations consisting of relatively high concentrations tripeptides which have ACE inhibitory properties in vitro and which may have beneficial effects on blood pressure.
Study population: 84 female and male Caucasians with a high-normal blood pressure or mild hypertension, aged 30 - 70 years at Day 01 of the study and with a BMI 18 - 32 kg/m2, will participate in the study.
Intervention: All subjects receive all treatments, but in a different order. One of the treatments consists of daily consumption of two capsules Casigold containing IPP during a period of 4 weeks. One of the treatments consists of daily consumption of two capsules Casimax containing a mixture of tripeptides during a period of 4 weeks. And one of the treatments consists of daily consumption of two capsules placebo during a period of 4 weeks. One capsule will be taken upon completion of breakfast and one capsule will be taken upon completion of dinner.
Main study parameters: The main study parameter is the blood pressure after 4 weeks of each treatment. Blood pressure will be measured at the study site on the two last days of each treatment period. Other study parameters include evaluation of safety at the end of each treatment period, and determination of genetic polymorphisms. Analysis of renin and angiotensin I and II will only be done in case a change in BP is found.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00471263
|TNO Quality of Life|
|Zeist, Netherlands, P.O.Box 360|
|Principal Investigator:||Esther Boelsma, PhD||TNO|