The Effects of Milk Proteins on Blood Pressure

This study has been completed.
Sponsor:
Collaborator:
DSM Food Specialties
Information provided by:
TNO
ClinicalTrials.gov Identifier:
NCT00471263
First received: May 8, 2007
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Blood Pressure
Drug: Casigold
Drug: Casimax
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Effects of Casigold and Casimax on Blood Pressure in Subjects With Highnormal Blood Pressure or Mild Hypertension

Resource links provided by NLM:


Further study details as provided by TNO:

Primary Outcome Measures:
  • Blood pressure [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 84
Study Start Date: May 2007
Study Completion Date: February 2008
Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy female and male Caucasians
  • Age between 30 and 70 years at Day 01 of the study
  • Body Mass Index (BMI) 18 - 32 kg/m2
  • Blood pressure: SBP 120-139 mmHg/DBP 80-89 mmHg (pre-hypertension) or SBP 140-159/DBP 90-99 mmHg (stage 1 hypertension)
  • Voluntary participation
  • Having given their written informed consent
  • Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
  • Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned

Exclusion Criteria:

  • Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or systolic blood pressure ≥ 160 mm Hg after repeated measurements
  • Any concomitant medication, with the exception of paracetamol, that may influence the outcome of the study
  • Intolerance or allergy to milk products
  • Not willing to give up consumption of >1 fermented dairy product per day
  • Alcohol consumption > 28 units/week for males or > 21 units/week for females women)
  • Smoking
  • Reported unexplained weight loss or weight gain of > 2 kg in the month prior to pre-study screening or during the study
  • Reported slimming or medically prescribed diet
  • Reported vegan, vegetarian or macrobiotic life-style
  • Participation in night shift work
  • Pregnant or lactating or wishing to became pregnant in the period of the study
  • Not having a general practitioner
  • Not willing to accept information-transfer concerning participation in the study, or information regarding a subject's health to and from a subject's general practitioner.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471263

Locations
Netherlands
TNO Quality of Life
Zeist, Netherlands, P.O.Box 360
Sponsors and Collaborators
TNO
DSM Food Specialties
Investigators
Principal Investigator: Esther Boelsma, PhD TNO
  More Information

No publications provided by TNO

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. J. Kloek, DSM Food Specialties
ClinicalTrials.gov Identifier: NCT00471263     History of Changes
Other Study ID Numbers: P7365
Study First Received: May 8, 2007
Last Updated: April 4, 2008
Health Authority: Netherlands: Dutch Health Care Inspectorate

ClinicalTrials.gov processed this record on July 24, 2014