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Nutritional Supplements on Blood Pressure 2008

Primary Purpose

Hypertension

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NanoGreens
Whey protein
Calcium pills
Sponsored by
Logan College of Chiropractic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring hypertension, supplement, HRV

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Logan University, College of ChiropracticRecruiting
  • Logan University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Fruit and vegetables

Whey protein

Ca

Arm Description

Fruits and vegetables

Whey protein

Calcium pills

Outcomes

Primary Outcome Measures

Blood pressure and HRV

Secondary Outcome Measures

Full Information

First Posted
January 25, 2008
Last Updated
October 27, 2008
Sponsor
Logan College of Chiropractic
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1. Study Identification

Unique Protocol Identification Number
NCT00609570
Brief Title
Nutritional Supplements on Blood Pressure 2008
Official Title
Effects of Nutritional Supplements on Blood Pressure and Heart Rate Variability
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
July 2009 (Anticipated)
Study Completion Date
July 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Logan College of Chiropractic

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
hypertension, supplement, HRV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fruit and vegetables
Arm Type
Experimental
Arm Description
Fruits and vegetables
Arm Title
Whey protein
Arm Type
Active Comparator
Arm Description
Whey protein
Arm Title
Ca
Arm Type
Active Comparator
Arm Description
Calcium pills
Intervention Type
Dietary Supplement
Intervention Name(s)
NanoGreens
Intervention Description
fruits and vegetables
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey protein
Other Intervention Name(s)
NanoPro
Intervention Description
Whey
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium pills
Other Intervention Name(s)
CA
Intervention Description
CA
Primary Outcome Measure Information:
Title
Blood pressure and HRV
Time Frame
every two weeks for three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 20-70 Hypertensive male and female subjects. Exclusion Criteria: Severe cardiovascular and renal conditions. Pregnancies and taking medications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Zhang, MD PhD
Phone
636 230 1920
Email
john.zhang@logan.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Zhang, MD, PhD
Organizational Affiliation
Logan University
Official's Role
Study Chair
Facility Information:
Facility Name
Logan University, College of Chiropractic
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Zhang, MD, Phd
Phone
636-230-1920
Email
john.zhang@logan.edu
Facility Name
Logan University
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Zhang, MD, PhD
Phone
636-230-1920
Email
john.zhang@logan.edu

12. IPD Sharing Statement

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Nutritional Supplements on Blood Pressure 2008

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