Metabolic SyndromePhase 1/2NCT01224743
Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome
A Phase 1/2 study testing Blend 1 and Blend 2 in people with Metabolic Syndrome, run by Griffin Hospital at 1 site in United States.
Trial summary
Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Blend 1 and Blend 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Mar 2008
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- metabolic syndrome defined by AHA/NHLBI criteria
- nonsmoker
- not taking any other vitamins or dietary supplements
- able to have blood pressure measured bilaterally at the brachial artery
Who cannot join
- any unstable medical condition that would limit the ability to participate fully in the trial
- rheumatologic disease requiring regular use of NSAIDs
- preexisting cardiovascular disease
- diagnosed eating disorder
- inability to complete endothelial function assessment.
- use of insulin, glucose sensitizing medication, vasoactive medications (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators), nutriceuticals, fiber supplements, and tobacco.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial
Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover clinical trial with three treatment arms.
- Conditions
- Metabolic Syndrome
- Being tested
- Blend 1, Blend 2, Placebo
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blend 1Dietary supplement
Also called Juice Plus+® Orchard, Garden, Vineyard
Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
Blend 2Dietary supplement
Also called Juice Plus+® Orchard, Garden
Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
PlaceboDietary supplement
Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding. Receives: Dietary Supplement: Placebo |
| Blend 2 | Experimental | Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends Receives: Dietary Supplement: Blend 2 |
| Blend 1 | Experimental | Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends Receives: Dietary Supplement: Blend 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Endothelial function as flow-mediated dilatation (FMD)
Measured: 8-weeks
Secondary outcomes (3)
Weight
Measured on a calibrated scale
Measured: 8-weeks
Lipid panel
Total cholesterol, TG, HDL, LDL, ratio
Measured: 8-weeks
Insulin
Serum insulin
Measured: 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startDec 2004
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Griffin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- NSA, LLC
- Investigators
- David L Katz, MD, MPH, Principal investigator, Yale-Griffin Prevention Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224743
- Sponsor's protocol ID
- 2004-22
- Status last verified
- Mar 2020
- First submitted
- 14 Oct 2010
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Ali A, Yazaki Y, Njike VY, Ma Y, Katz DL. Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial. Nutr J. 2011 Jun 29;10:72. doi: 10.1186/1475-2891-10-72.
PubMed 21714890
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fruit and Vegetable Concentrates on Endothelial Function in Persons With Metabolic Syndrome: A Randomized, Controlled, Crossover Trial
- ClinicalTrials.gov ID
- NCT01224743
- Acronym / sponsor ID
- 2004-22
- Conditions
- Metabolic Syndrome
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- NSA, LLC
- Study start
- Dec 2004
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 20 Oct 2010 (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.
Dehydrated fruit and vegetable concentrates provide an accessible form of phytonutrient supplementation that may offer cardioprotective effects. This study assessed the effects of encapsulated fruit and vegetable juice powder concentrates on endothelial function and cardiac risk markers in subjects in a randomized, double blind, placebo controlled crossover clinical trial with three treatment arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding. |
| Blend 2 | Experimental | Dietary Supplement: Blend 2Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends |
| Blend 1 | Experimental | Dietary Supplement: Blend 1Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- metabolic syndrome defined by AHA/NHLBI criteria
- nonsmoker
- not taking any other vitamins or dietary supplements
- able to have blood pressure measured bilaterally at the brachial artery
Key exclusion criteria (6 listed)
- any unstable medical condition that would limit the ability to participate fully in the trial
- rheumatologic disease requiring regular use of NSAIDs
- preexisting cardiovascular disease
- diagnosed eating disorder
- inability to complete endothelial function assessment.
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 |
|---|---|---|
| Blend 1Also: Juice Plus+® Orchard, Garden, VineyardBlend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends | Dietary supplement | Blend 1 |
| Blend 2Also: Juice Plus+® Orchard, GardenBlend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends | Dietary supplement | Blend 2 |
| PlaceboPlacebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding. | Dietary supplement | Placebo |
Primary outcome
Endothelial Function
Time frame: 8-weeks
Endothelial function as flow-mediated dilatation (FMD)
3 secondary outcomes
Weight
Time frame: 8-weeks
Lipid panel
Time frame: 8-weeks
Insulin
Time frame: 8-weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Derived from this study: PubMed 21714890Ali A, Yazaki Y, Njike VY, Ma Y, Katz DL. Effect of fruit and vegetable concentrates on endothelial function in metabolic syndrome: a randomized controlled trial. Nutr J. 2011 Jun 29;10:72. doi: 10.1186/1475-2891-10-72.
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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.
David L Katz, MD, MPH principal investigator
Yale-Griffin Prevention Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Blend 1 and Blend 2 in people with Metabolic Syndrome, run by Griffin Hospital at 1 site 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01224743, which also lists 1 linked publication.
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 26 Mar 2020.