- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00609570
Nutritional Supplements on Blood Pressure 2008
October 27, 2008 updated by: Logan College of Chiropractic
Effects of Nutritional Supplements on Blood Pressure and Heart Rate Variability
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Missouri
-
Chesterfield, Missouri, United States, 63006
- Recruiting
- Logan University, College of Chiropractic
-
Chesterfield, Missouri, United States, 63017
- Not yet recruiting
- Logan University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 20-70
- Hypertensive male and female subjects.
Exclusion Criteria:
- Severe cardiovascular and renal conditions.
- Pregnancies and taking medications.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Fruit and vegetables
Fruits and vegetables
|
fruits and vegetables
|
|
Active Comparator: Whey protein
|
Whey
Other Names:
|
|
Active Comparator: Ca
Calcium pills
|
CA
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood pressure and HRV
Time Frame: every two weeks for three months
|
every two weeks for three months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: John Zhang, MD, PhD, Logan University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
July 1, 2009
Study Completion (Anticipated)
July 1, 2009
Study Registration Dates
First Submitted
January 25, 2008
First Submitted That Met QC Criteria
February 6, 2008
First Posted (Estimate)
February 7, 2008
Study Record Updates
Last Update Posted (Estimate)
October 28, 2008
Last Update Submitted That Met QC Criteria
October 27, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RD0920070111
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.