HypertensionPhase 1NCT00609570
Nutritional Supplements on Blood Pressure 2008
A Phase 1 study testing NanoGreens, Whey protein and Calcium pills in people with Hypertension, run by Logan College of Chiropractic at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- NanoGreens, Whey protein and Calcium pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Jul 2009
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-70
- Hypertensive male and female subjects.
Who cannot join
- Severe cardiovascular and renal conditions.
- Pregnancies and taking medications.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Logan University, College of Chiropractic
Chesterfield, Missouri, 63006
John Zhang, MD, Phd, 636-230-1920, john.zhang@logan.edu
- Not yet recruiting
Logan University
Chesterfield, Missouri, 63017
John Zhang, MD, PhD, 636-230-1920, john.zhang@logan.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertension
- Being tested
- NanoGreens, Whey protein, Calcium pills
- Keywords
- hypertension, supplement, HRV
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NanoGreensDietary supplement
fruits and vegetables
Whey proteinDietary supplement
Also called NanoPro
Whey
Calcium pillsDietary supplement
Also called CA
CA
| Study group | Role | What they receive |
|---|---|---|
| Fruit and vegetables | Experimental | Fruits and vegetables Receives: Dietary Supplement: NanoGreens |
| Whey protein | Active comparator | Whey protein Receives: Dietary Supplement: Whey protein |
| Ca | Active comparator | Calcium pills Receives: Dietary Supplement: Calcium pills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure and HRV
Measured: every two weeks for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startOct 2008
- Primary completionJul 2009 (estimated)
- Study completionJul 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Logan College of Chiropractic
- Sponsor type
- University, hospital or other
- Investigators
- John Zhang, MD, PhD, Study chair, Logan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00609570
- Sponsor's protocol ID
- RD0920070111
- Status last verified
- Oct 2008
- First submitted
- 25 Jan 2008
- Last updated
- 28 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nutritional Supplements on Blood Pressure and Heart Rate Variability
- ClinicalTrials.gov ID
- NCT00609570
- Acronym / sponsor ID
- RD0920070111
- Conditions
- Hypertension
- Keywords
- hypertension, supplement, HRV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Logan College of ChiropracticUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2009 (estimated)
- Study completion
- Jul 2009 (estimated)
- First posted
- 7 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fruit and vegetables | Experimental | Dietary Supplement: NanoGreensFruits and vegetables |
| Whey protein | Active comparator | Dietary Supplement: Whey proteinWhey protein |
| Ca | Active comparator | Dietary Supplement: Calcium pillsCalcium pills |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 20-70
- Hypertensive male and female subjects.
Key exclusion criteria (2 listed)
- Severe cardiovascular and renal conditions.
- Pregnancies and taking medications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NanoGreensfruits and vegetables | Dietary supplement | Fruit and vegetables |
| Whey proteinAlso: NanoProWhey | Dietary supplement | Whey protein |
| Calcium pillsAlso: CACA | Dietary supplement | Ca |
Primary outcome
Blood pressure and HRV
Time frame: every two weeks for three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Zhang, MD, PhD study chair
Logan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NanoGreens, Whey protein and Calcium pills in people with Hypertension, run by Logan College of Chiropractic at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John Zhang, MD PhD (636 230 1920, john.zhang@logan.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure and HRV (time frame: every two weeks for three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2008.