verhoogde bloeddruk high blood pressure hypertension
Conditions
Interventions
All subjects receive all treatments (cross-over), but in a different order
(randomised). One of the treatments consists of daily consumption of two
capsules Casigold containing in total 15 mg IPP du
Sponsors
DSM Food Specialties
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1.Healthy as assessed by the TNO health and lifestyle questionnaire, physical examination, results of the pre-study laboratory tests; 2.Female and male Caucasians 3.Age 30 - 70 years at Day 01 of the study 4.Body Mass Index (BMI) 18 - 32 kg/m2 5.Blood pressure (automated BP measurements at site): SBP 120-139 mmHg/DBP 80-89 mmHg (pre-hypertension) or SBP 140-159/DBP 90-99 mmHg (stage 1 hypertension). Ratio pre-hypertension: stage 1 hypertension must be 1:1. 6.Normal Dutch eating habits; consuming mostly three main meals including breakfast and dinner 7.Voluntary participation 8.Having given their written informed consent 9.Willing to comply with the study procedures 10.Appropriate veins for blood sampling according to TNO 11.Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years 12.Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
Exclusion criteria
Exclusion criteria: 1.Having a history of medical or surgical events that may significantly affect the study outcome, including cardiovascular disease or hypertension >=160/100 mm Hg after repeated measurements 2.Any concomitant medication, with the exception of paracetamol, that may influence the outcome of the study (e.g. ACE inhibitory drugs or other BP lowering medication) 3.Intolerance or allergy to milk products 4.Not willing to give up consumption of >1 fermented dairy product per day 5.Alcohol consumption > 28 units/week for males or > 21 units/week for females women) 6.Smoking 7.Reported unexplained weight loss or weight gain of > 2 kg in the month prior to pre-study screening 8.Reported slimming or medically prescribed diet 9.Reported vegan, vegetarian or macrobiotic life-style 10.Participation in night shift work 11.Pregnant or lactating or wishing to became pregnant in the period of the study 12.Recent blood or plasma donation (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is the blood pressure after 4 weeks of treatment. Blood pressure will be measured at the study site on the two final treatment days in last week of each treatment using automated digital sphygmomanometry (OMRON IC) between 2.5 and 3.5 h after ingestion of the morning capsule. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters include evaluation of safety at the end of each treatment, mechanistic parameters (renin, angiotensin I and II), and blood pressure-related genetic polymorphisms. | — |
Countries
Netherlands
Outcome results
None listed