The Effects of Milk Proteins on Blood Pressure

NCT00471263 | Completed

• 1 other identifier: P7365
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

• Blood pressure

  4 weeks

Secondary Outcomes (3)

• Safety data in blood and urine

  4 weeks

• Genetic determinants of the individual BP lowering response by measurement of specific genetic polymorphisms.

  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).

  4 weeks

Interventions

Casigold DRUG

Casimax DRUG

Placebo DRUG

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TNO: lead
• DSM Food Specialties: collaborator

Study Sites (1)

TNO Quality of Life

Zeist, P.O.Box 360, Netherlands

Location

Related Publications (1)

• Boelsma E, Kloek J. IPP-rich milk protein hydrolysate lowers blood pressure in subjects with stage 1 hypertension, a randomized controlled trial. Nutr J. 2010 Nov 8;9:52. doi: 10.1186/1475-2891-9-52.

  PMID: 21059213 DERIVED

Study Officials

• Esther Boelsma, PhD

  TNO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 8, 2007
• First Posted: May 9, 2007
• Study Start: May 7, 2007
• Primary Completion: December 18, 2007
• Study Completion: February 1, 2008
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

NL (1)