NCT01161706

Brief Summary

The purpose of the investigators study is to investigate the impact of a commercial vegetable juice on dietary vegetable intake and select cardiovascular risk factors in a generally healthy population. The study was a 12 week study with 3 groups who received 0, 8 or 16 fluid ounces daily of vegetable juice, along with education on the DASH (Dietary Approaches to Stop Hypertension) diet. All participants came in for 3 study visits at 0, 6 and 12 weeks into the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2007

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

July 1, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 12, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2010

Completed
Last Updated

July 13, 2010

Status Verified

July 1, 2010

Enrollment Period

5 months

First QC Date

July 12, 2010

Last Update Submit

July 12, 2010

Conditions

VegetablesCardiovascular DiseaseBlood Pressure

Keywords

vegetable juicecardiovascularblood pressure

Outcome Measures

Primary Outcomes (2)

  • Dietary Vegetable Intake

    6 and 12 weeks

  • Dietary Nutrient Intake (vitamins & minerals)

    6 and 12 weeks

Secondary Outcomes (1)

  • Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)

    0, 6 and 12 weeks

Study Arms (3)

Control

NO INTERVENTION

0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet

8 fluid ounces vegetable juice

EXPERIMENTAL

8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet

Other: Vegetable Juice

16 fluid ounces vegetable juice

EXPERIMENTAL

16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet

Other: Vegetable Juice

Interventions

Vegetable JuiceOTHER

Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.

Also known as: Commercial vegetable juice provided by Campbell Soup Company
16 fluid ounces vegetable juice8 fluid ounces vegetable juice

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40 to 65 yrs
  • Subject's body mass index is between 18.5 - 34.9 kg/m2
  • Subject is willing and able to comply with the study protocols
  • Subject is willing to consume a vegetable-based beverage daily for three months

You may not qualify if:

  • Physical signs of health impairment
  • Uncontrolled diabetes or hypertension
  • Pregnant or lactating
  • Active tuberculosis or lung disease (i.e. COPD)
  • Renal or Liver disease
  • Heart Disease, which includes Cardiovascular events and Stroke
  • Cushing's syndrome
  • Exercise trained individuals
  • History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year
  • Anxiety medications
  • Use of MAOI inhibitors within the last 1 year (e.g., phenelzine (Nardil), tranylcypromine (Parnate), etc.)
  • Quality of life score of 21 or above
  • Routine use of prescription drugs or over-the counter medications, which may potentially modulate the outcome of this study; including antibiotics, aspirin and aspirin-containing formulations, COX-2 inhibitors, antihistamines, corticosteroids, erectile dysfunction drugs
  • Asthma (can be worsened by mild to moderate food allergies)
  • Indications of substance or alcohol abuse within the last 3 years
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ragle Human Nutrition Research Center (1283 Academic Surge)

Davis, California, 95616, United States

Location

Related Publications (1)

  • Shenoy SF, Kazaks AG, Holt RR, Chen HJ, Winters BL, Khoo CS, Poston WS, Haddock CK, Reeves RS, Foreyt JP, Gershwin ME, Keen CL. The use of a commercial vegetable juice as a practical means to increase vegetable intake: a randomized controlled trial. Nutr J. 2010 Sep 17;9:38. doi: 10.1186/1475-2891-9-38.

    PMID: 20849620DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Fruit and Vegetable Juices

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Carl L Keen, PhD

    Professor of Nutrition

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 12, 2010

First Posted

July 13, 2010

Study Start

July 1, 2007

Primary Completion

December 1, 2007

Study Completion

February 1, 2009

Last Updated

July 13, 2010

Record last verified: 2010-07

Locations

US(1)