NCT01224743

Brief 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, double blind, placebo controlled crossover clinical trial with three treatment arms.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Dec 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 20, 2010

Completed
Last Updated

March 26, 2020

Status Verified

March 1, 2020

Enrollment Period

3.2 years

First QC Date

October 14, 2010

Last Update Submit

March 25, 2020

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Endothelial Function

    Endothelial function as flow-mediated dilatation (FMD)

    8-weeks

Secondary Outcomes (3)

  • Weight

    8-weeks

  • Lipid panel

    8-weeks

  • Insulin

    8-weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.

Dietary Supplement: Placebo

Blend 2

EXPERIMENTAL

Blend 2 - combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends

Dietary Supplement: Blend 2

Blend 1

EXPERIMENTAL

Blend 1 - combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends

Dietary Supplement: Blend 1

Interventions

Blend 1DIETARY_SUPPLEMENT

Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends

Also known as: Juice Plus+® Orchard, Garden, Vineyard
Blend 1
Blend 2DIETARY_SUPPLEMENT

Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends

Also known as: Juice Plus+® Orchard, Garden
Blend 2
PlaceboDIETARY_SUPPLEMENT

Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Griffin Hospital

Derby, Connecticut, 06418, United States

Location

Related Publications (1)

  • 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.

    PMID: 21714890DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

GardensFarms

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

AgricultureTechnology, Industry, and AgricultureNon-Medical Public and Private FacilitiesManufacturing and Industrial Facilities

Study Officials

  • David L Katz, MD, MPH

    Yale-Griffin Prevention Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 14, 2010

First Posted

October 20, 2010

Study Start

December 1, 2004

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

March 26, 2020

Record last verified: 2020-03

Locations

US(1)