LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects.
This study has been completed.
Sponsor:
Wageningen University
Collaborator:
Unilever R&D
Information provided by:
Wageningen University
ClinicalTrials.gov Identifier:
NCT00167869
First received: September 12, 2005
Last updated: May 23, 2008
Last verified: May 2008
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | September 12, 2005 | ||||
| Last Updated Date | May 23, 2008 | ||||
| Start Date ICMJE | June 2004 | ||||
| Primary Completion Date | June 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Blood pressure | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00167869 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects. | ||||
| Official Title ICMJE | LACTOPRES:Study on the Effect of Dairy Peptides on Blood Pressure in Untreated Hypertensive Subjects. | ||||
| Brief Summary | Hypertension is an increasingly important medical and public health issue. Literature suggests that there may be a role for dairy foods in the prevention and treatment of hypertension. Recently, it has been suggested that several peptides in milk proteins could have blood pressure lowering properties. LACTOPRES is a randomised, double-blind parallel trial to assess the blood pressure effect of an increased intake of dairy peptides in humans. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
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| Condition ICMJE | Hypertension | ||||
| Intervention ICMJE | Behavioral: dairy peptides | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 135 | ||||
| Completion Date | June 2005 | ||||
| Primary Completion Date | June 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years to 70 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Netherlands | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00167869 | ||||
| Other Study ID Numbers ICMJE | METC-WU 04/04 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Wageningen University | ||||
| Collaborators ICMJE | Unilever R&D | ||||
| Investigators ICMJE |
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| Information Provided By | Wageningen University | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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