The Effects of Milk Proteins on Blood Pressure

• Status: Completed
• Trial end date: 2008-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: TNO
• Collaborator: DSM Food Specialties

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.