Overweight and ObesityNCT01533987
Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men
A study testing Juice Plus in people with Overweight and Obesity, run by Griffin Hospital at 1 site in United States.
Trial summary
The purpose of the study is to determine the effects of daily ingestion of Juice Plus+® capsules containing Orchard, Garden and Vineyard blends on endothelial function and biomarkers of oxidative stress (oxidized LDL, lipid hydroperoxides and protein carbonyls) in overweight men as compared to the placebo group. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Juice Plus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Aug 2010
- Phase
- Interventional
- 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 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male age 25-75 years
- Healthy (no known diabetes mellitus, cardiovascular disease, or eating disorder)
- Non-smoker
- Overweight (BMI ≥25) with central adiposity as indicated by waist circumference (≥102 cm).
- Endothelial dysfunction with high-fat meal
Who cannot join
- Use of lipid-lowering or antihypertensive medications, unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning;
- Regular use of multivitamins and/or complementary or alternative supplement therapy (including all Juice Plus+® products) and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration
- Anticipated inability to complete or comply with study protocol;
- Diagnosed eating disorder
- Any rheumatologic disease requiring regular use of NSAIDs or alternative medications
- Regular use of fiber supplements
Show all 9Show fewer
- Use of insulin, glucose sensitizing medication, or vasoactive medication
- Substance abuse (chronic alcoholism, or other chemical dependency
- Pre-existing cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale-Griffin Prevention Research Center
Derby, Connecticut, 06418
About this study
Official title: Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men: A Randomized, Controlled Trial
The purpose of the study is to determine the effects of daily ingestion of Juice Plus+® capsules containing Orchard, Garden and Vineyard blends on endothelial function and biomarkers of oxidative stress (oxidized LDL, lipid hydroperoxides and protein carbonyls) in overweight men as compared to the placebo group.
Read the detailed description
The prevalence of obesity in both adults and children in the United States has increased significantly over the past 50 years. More than 66% of adults in the US are now overweight or obese and at least 17% of children in the population at large are now considered overweight. Obesity may be a factor predisposing patients to a myriad of different comorbidities that increase the associated mortality rate. Several large prospective trials have documented that obesity is an independent risk factor for all-cause mortality from cardiovascular disease (CVD). Considering the major metabolic and biochemical changes that occur in obesity, such as atherogenic dyslipidemia, insulin resistance and hyperinsulinemia, endothelial dysfunction, and chronic inflammatory and prothrombotic states, obesity plays a role in the pathogenesis of systemic atherosclerosis and its clinical complications. Antioxidants are thought to help preserve the endothelium's capacity to generate NO, which acts to promote vasodilation, stabilize platelets, and promote the anti-inflammatory abilities of the endothelium. Juice Plus+® Capsules containing Orchard, Garden and Vineyard blends are rich in the traditional antioxidants β-carotene, Vitamin E and Vitamin C along with other carotenoids and phytonutrients. There is increasing attention to the possibility that micronutrients may exert health effects in concert. Outcomes in studies of isolated micronutrients, such as vitamin E, have often been often disappointing. Plant-derived micronutrients have the potential to contribute to vascular health by offering the endothelium protection from oxidative stress. Evidence of this anticipated effect would have implications for strategies to prevent or retard cardiovascular disease. Endothelial function testing using high-frequency ultrasound imaging of the brachial artery to assess endothelium-dependent flow-mediated dilatation (FMD) offers a non-invasive, uniquely valuable means of assessing aggregated influences on cardiac risk by gauging a physiologic response of the vascular endothelium. Proposed, therefore, is a randomized, double-blinded and placebo-controlled clinical trial of Juice Plus+® on endothelial function in overweight men with central adiposity.
- Conditions
- Overweight and Obesity
- Being tested
- Juice Plus
- Keywords
- Male, Overweight, Juice Plus
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Juice PlusDietary supplement
Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.
| Study group | Role | What they receive |
|---|---|---|
| Juice Plus | Experimental | Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend. Receives: Dietary Supplement: Juice Plus |
| Placebo | Placebo comparator | The placebo consists of microcrystalline cellulose,dicalcium phosphate, magnesium stearate, and FD \& C yellow #6. Receives: Dietary Supplement: Juice Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Brachial artery flow mediated dilation (FMD)
Measured: 8 weeks
Secondary outcomes (4)
Weight
Measured: 8 weeks
Waist Circumference
Measured: 8 weeks
Blood pressure
Measured: 8 weeks
Serum biomarker measures
These samples will be used to assess participants' biomarkers of oxidative stress (i.e. oxidized LDL levels, lipid hydroperoxides, and protein carbonyls) and compliance measure (i.e. serum carotenoids)
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 posted16 Feb 2012 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight and ObesityStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 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
- NCT01533987
- Sponsor's protocol ID
- 2009-06
- Status last verified
- Aug 2011
- First submitted
- 9 Aug 2011
- Last updated
- 16 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Juice Plus+® Supplementation on Endothelial Function in Overweight Men: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT01533987
- Acronym / sponsor ID
- 2009-06
- Conditions
- Overweight and Obesity
- Keywords
- Male, Overweight, Juice Plus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Griffin HospitalUniversity, hospital or other
- Collaborators
- NSA, LLC
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 16 Feb 2012 (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.
The purpose of the study is to determine the effects of daily ingestion of Juice Plus+® capsules containing Orchard, Garden and Vineyard blends on endothelial function and biomarkers of oxidative stress (oxidized LDL, lipid hydroperoxides and protein carbonyls) in overweight men as compared to the placebo group.
Detailed description
The prevalence of obesity in both adults and children in the United States has increased significantly over the past 50 years. More than 66% of adults in the US are now overweight or obese and at least 17% of children in the population at large are now considered overweight. Obesity may be a factor predisposing patients to a myriad of different comorbidities that increase the associated mortality rate. Several large prospective trials have documented that obesity is an independent risk factor for all-cause mortality from cardiovascular disease (CVD). Considering the major metabolic and biochemical changes that occur in obesity, such as atherogenic dyslipidemia, insulin resistance and hyperinsulinemia, endothelial dysfunction, and chronic inflammatory and prothrombotic states, obesity plays a role in the pathogenesis of systemic atherosclerosis and its clinical complications. Antioxidants are thought to help preserve the endothelium's capacity to generate NO, which acts to promote vasodilation, stabilize platelets, and promote the anti-inflammatory abilities of the endothelium. Juice Plus+® Capsules containing Orchard, Garden and Vineyard blends are rich in the traditional antioxidants β-carotene, Vitamin E and Vitamin C along with other carotenoids and phytonutrients. There is increasing attention to the possibility that micronutrients may exert health effects in concert. Outcomes in studies of isolated micronutrients, such as vitamin E, have often been often disappointing. Plant-derived micronutrients have the potential to contribute to vascular health by offering the endothelium protection from oxidative stress. Evidence of this anticipated effect would have implications for strategies to prevent or retard cardiovascular disease. Endothelial function testing using high-frequency ultrasound imaging of the brachial artery to assess endothelium-dependent flow-mediated dilatation (FMD) offers a non-invasive, uniquely valuable means of assessing aggregated influences on cardiac risk by gauging a physiologic response of the vascular endothelium. Proposed, therefore, is a randomized, double-blinded and placebo-controlled clinical trial of Juice Plus+® on endothelial function in overweight men with central adiposity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Juice Plus | Experimental | Dietary Supplement: Juice PlusJuice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend. |
| Placebo | Placebo comparator | Dietary Supplement: Juice PlusThe placebo consists of microcrystalline cellulose,dicalcium phosphate, magnesium stearate, and FD \& C yellow #6. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male age 25-75 years
- Healthy (no known diabetes mellitus, cardiovascular disease, or eating disorder)
- Non-smoker
- Overweight (BMI ≥25) with central adiposity as indicated by waist circumference (≥102 cm).
- Endothelial dysfunction with high-fat meal
Key exclusion criteria (9 listed)
- Use of lipid-lowering or antihypertensive medications, unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to EF scanning;
- Regular use of multivitamins and/or complementary or alternative supplement therapy (including all Juice Plus+® products) and unwillingness to discontinue supplementation for at least 8 weeks prior to study initiation and for study duration
- Anticipated inability to complete or comply with study protocol;
- Diagnosed eating disorder
- Any rheumatologic disease requiring regular use of NSAIDs or alternative 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 |
|---|---|---|
| Juice PlusJuice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend. | Dietary supplement | Juice Plus, Placebo |
Primary outcome
Endothelial Function
Time frame: 8 weeks
Brachial artery flow mediated dilation (FMD)
4 secondary outcomes
Weight
Time frame: 8 weeks
Waist Circumference
Time frame: 8 weeks
Blood pressure
Time frame: 8 weeks
Serum biomarker measures
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 16 Feb 2012.
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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 study testing Juice Plus in people with Overweight and Obesity, 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 5 inclusion and 9 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 16 Feb 2012. 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.
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?
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 16 Feb 2012.