Nutritional Supplements on Blood Pressure 2008 | NCT00609570

Studies
Nutritional Supplements on Blood Pressure 2008

NCT00609570

Sponsor

Logan College of Chiropractic

Status

Unknown status

Last Update Posted

Oct 28, 2008Estimated

Enrollment

60Estimated

Phase

Phase 1

Conditions

Hypertension

Interventions

NanoGreens
Whey protein
Calcium pills

Countries

United States

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

Oct 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Jul 2009Estimated

Completion Date

Jul 2009Estimated

First Submitted Date

Jan 25, 2008

First Submission Date that Met QC Criteria

Feb 6, 2008

First Posted Date

Feb 7, 2008Estimated

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

Oct 27, 2008

Last Update Posted Date

Oct 28, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Hypertensive participants will be randomly assigned into three groups. The first group of participants will take the fruits and vegetable powders mixed with water. The second group takes whey protein and the third group takes calcium pills. Blood pressure and heart rate variability will be measured every two weeks for three months.

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
NanoGreens	Dietary Supplement	fruits and vegetables	Fruit and vegetables

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure and HRV		every two weeks for three months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 20-70
Hypertensive male and female subjects.

Exclusion Criteria:

Severe cardiovascular and renal conditions.
Pregnancies and taking medications.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
John Zhang, MD PhD	Contact	636 230 1920		john.zhang@logan.edu

Overall Officials

Name	Affiliation	Role
John Zhang, MD, PhD	Logan University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Logan University, College of Chiropractic	Recruiting	Chesterfield	Missouri	63006	United States

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
D000067816	Whey Proteins

Ancestor Terms

ID	Term
D008894	Milk Proteins
D000080224	Animal Proteins, Dietary
D004044	Dietary Proteins
D011506	Proteins

Browse Leaves

Not provided

Browse Branches

Not provided