Status:
COMPLETED
The Effects of Milk Proteins on Blood Pressure
Lead Sponsor:
TNO
Collaborating Sponsors:
DSM Food Specialties
Conditions:
Blood Pressure
Eligibility:
All Genders
30-70 years
Phase:
NA
Brief 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 t...
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 V...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 7 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2008
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00471263
Start Date
May 7 2007
End Date
February 1 2008
Last Update
January 24 2024
Active Locations (1)
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1
TNO Quality of Life
Zeist, Netherlands, P.O.Box 360