NCT00167869

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
135

participants targeted

Target at P50-P75 for phase_2 hypertension

Timeline
Completed

Started Jun 2004

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

Study Start

First participant enrolled

June 1, 2004

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

May 29, 2008

Status Verified

May 1, 2008

Enrollment Period

1 year

First QC Date

September 12, 2005

Last Update Submit

May 23, 2008

Conditions

Hypertension

Keywords

hypertensionblood pressuredairy peptidesbioactive peptidesrandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Blood pressure

Interventions

dairy peptidesBEHAVIORAL

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • systolic blood pressure \>= 140 mmHg
  • BMI between 18 and 32 kg/m2
  • apparently healthy

You may not qualify if:

  • antihypertensive medication
  • medically prescribed or slimming diet
  • lactating, pregnant
  • irregular pulse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wageningen University, Division of Human Nutrition

Wageningen, 6700 EV, Netherlands

Location

Related Links

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Frans J Kok, PhD

    Wageningen University - Division of Human Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 14, 2005

Study Start

June 1, 2004

Primary Completion

June 1, 2005

Study Completion

June 1, 2005

Last Updated

May 29, 2008

Record last verified: 2008-05

Locations

NL(1)