NCT01031485

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 11, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 14, 2009

Completed
18 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

December 23, 2014

Status Verified

December 1, 2009

Enrollment Period

5 months

First QC Date

December 11, 2009

Last Update Submit

December 19, 2014

Conditions

Stage 1 Hypertension

Keywords

hypertensionblood pressuremilk peptidesbioactive peptidesrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

Study Arms (2)

Spread with milk peptides and plant sterols

ACTIVE COMPARATOR
Dietary Supplement: Milk peptides and plant sterols

Standard spread

PLACEBO COMPARATOR
Other: Placebo

Interventions

Milk peptides and plant sterolsDIETARY_SUPPLEMENT
Spread with milk peptides and plant sterols
PlaceboOTHER
Standard spread

Eligibility Criteria

Age30 Years - 60 Years
Sexall
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Valio Ltd

Helsinki, Uusimaa, 00370, Finland

Location

MeSH Terms

Conditions

Hypertension

Interventions

Phytosterols

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SterolsCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsMembrane LipidsLipidsPhytochemicalsBiological Factors

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 11, 2009

First Posted

December 14, 2009

Study Start

January 1, 2010

Primary Completion

June 1, 2010

Study Completion

August 1, 2010

Last Updated

December 23, 2014

Record last verified: 2009-12

Locations

FI(1)