The Effects of Milk Proteins on Blood Pressure

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Blood Pressure

Clinical Trial Details

NCT number	NCT00471263
Study type	Interventional
Source	TNO
Contact
Status	Completed
Phase	N/A
Start date	May 7, 2007
Completion date	February 2008

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03255187` - Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution	N/A
Completed	`NCT05997303` - Continuous Norepinephrine Administration and Blood Pressure Stability During Anesthetic Induction	N/A
Recruiting	`NCT04575194` - Study of the Cardiometabolic Effects of Obesity Pharmacotherapy	Phase 4
Completed	`NCT03918486` - Caretaker vs. Routine Blood Pressure Sphygmomanometer
Completed	`NCT03410342` - The Effects of Types of Fruits and Vegetables on Vascular Function	N/A
Active, not recruiting	`NCT05062161` - Sleep Duration and Blood Pressure During Sleep	N/A
Not yet recruiting	`NCT04087070` - Blood Pressure Estimation Using Noninvasive Biosignals During Pediatric Anesthesia
Completed	`NCT03294928` - Arterial Waveform Analysis Applying Different Positive End-Expiratory Pressure (PEEP) Levels in Healthy Volunteers	N/A
Completed	`NCT03859934` - Metabolic Effects of Melatonin Treatment	Phase 1
Completed	`NCT03997461` - Comparison of Arterial Tonometry Sensor With Standard Oscillometric Blood Pressure Monitoring Device	N/A
Completed	`NCT03290716` - Diet, ExerCIse and carDiovascular hEalth (DECIDE) - Salt Reduction Strategies for the Elderly in Nursing Homes in China	N/A
Recruiting	`NCT05196048` - Blood Pressure Sensor of Watch-type Device With ECG Technology
Recruiting	`NCT06460233` - Blood Pressure Changes After Bariatric Surgery
Terminated	`NCT03325933` - Resistance Training and Cardiometabolic Health	N/A
Not yet recruiting	`NCT06405880` - Pharmacist Case Finding and Intervention for Vascular Prevention Trial	N/A
Completed	`NCT02924454` - Effects of Lipid Emulsion on the Pharmacokinetic and Pharmacodynamic Properties of Metoprolol.	Phase 4
Completed	`NCT02451059` - Reducing Socioeconomic Disparities in Health at Pediatric Visits	N/A
Active, not recruiting	`NCT02670967` - Effects of Soluble Fiber on Blood Pressure: A Meta-analysis of Randomly-controlled Trials	N/A
Completed	`NCT02271633` - Nitrate Supplementation; Source	Phase 4
Completed	`NCT02239744` - Intervention Study on the Health Impact of Air Filters in Chinese Adults	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.