NCT00609570

Brief Summary

Three different supplements will be used in the study (fruits and vegetable powders, whey protein and calcium) for patients with hypertension. The null hypothesis was that the supplements had no effects on participants' blood pressure.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_1 hypertension

Timeline
Completed

Started Oct 2008

Typical duration for phase_1 hypertension

Geographic Reach
1 country

2 active sites

Status
unknown

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

January 25, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 7, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

October 28, 2008

Status Verified

October 1, 2008

Enrollment Period

9 months

First QC Date

January 25, 2008

Last Update Submit

October 27, 2008

Conditions

Hypertension

Keywords

hypertensionsupplementHRV

Outcome Measures

Primary Outcomes (1)

  • Blood pressure and HRV

    every two weeks for three months

Study Arms (3)

Fruit and vegetables

EXPERIMENTAL

Fruits and vegetables

Dietary Supplement: NanoGreens

Whey protein

ACTIVE COMPARATOR

Whey protein

Dietary Supplement: Whey protein

Ca

ACTIVE COMPARATOR

Calcium pills

Dietary Supplement: Calcium pills

Interventions

NanoGreensDIETARY_SUPPLEMENT

fruits and vegetables

Fruit and vegetables
Whey proteinDIETARY_SUPPLEMENT

Whey

Also known as: NanoPro
Whey protein
Calcium pillsDIETARY_SUPPLEMENT

CA

Also known as: CA
Ca

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 20-70
  • Hypertensive male and female subjects.

You may not qualify if:

  • Severe cardiovascular and renal conditions.
  • Pregnancies and taking medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Logan University, College of Chiropractic

Chesterfield, Missouri, 63006, United States

RECRUITING

Logan University

Chesterfield, Missouri, 63017, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Hypertension

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • John Zhang, MD, PhD

    Logan University

    STUDY CHAIR

Central Study Contacts

John Zhang, MD PhD

CONTACT

636 230 1920john.zhang@logan.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 25, 2008

First Posted

February 7, 2008

Study Start

October 1, 2008

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 28, 2008

Record last verified: 2008-10

Locations

US(2)