Bioactive Milk Peptides and Blood Pressure | NCT01031485

Studies
Bioactive Milk Peptides and Blood Pressure

NCT01031485

Sponsor

Valio Ltd

Status

Completed

Last Update Posted

Dec 23, 2014Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Stage 1 Hypertension

Interventions

Milk peptides and plant sterols
Placebo

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Jun 2010Actual

Completion Date

Aug 2010Actual

First Submitted Date

Dec 11, 2009

First Submission Date that Met QC Criteria

Dec 11, 2009

First Posted Date

Dec 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 19, 2014

Last Update Posted Date

Dec 23, 2014Estimated

Name	Class
University of Helsinki	OTHER

Description Module

Brief Summary

The purpose of this study is to investigate the effects of bioactive milk peptides on blood pressure in mildly hypertensive subjects.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spread with milk peptides and plant sterols	Active Comparator		Dietary Supplement: Milk peptides and plant sterols
Standard spread	Placebo Comparator		Other: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Milk peptides and plant sterols	Dietary Supplement		Spread with milk peptides and plant sterols
Placebo

Measure	Description	Time Frame
Blood pressure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 30-60 years
systolic blood pressure 140-160 mmHg and diastolic blood pressure 90-99 mmHg in office measurement
apparently healthy

Exclusion Criteria:

antihypertensive and lipid-lowering drugs
unstable coronary artery disease, diabetes, malignant diseases, secondary hypertension
BMI > 32 kg/m2
milk allergy
smoking
alcohol abuse
pregnancy, lactation
simultaneous participation in other clinical trial

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Valio Ltd		Helsinki	Uusimaa	00370	Finland

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010840	Phytosterols

Ancestor Terms

ID	Term
D013261	Sterols
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided