Clinical Investigation on the Effects of a Vegetable Juice Treatment

NCT ID: NCT01161706

Last Updated: 2010-07-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2009-02-28

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.

Conditions

Vegetables; Cardiovascular Disease; Blood Pressure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

8 fluid ounces vegetable juice

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

Group Type: EXPERIMENTAL

Vegetable Juice

Intervention Type: OTHER

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

16 fluid ounces vegetable juice

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

Group Type: EXPERIMENTAL

Vegetable Juice

Intervention Type: OTHER

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

Interventions

Vegetable Juice

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

Intervention Type: OTHER

Other Intervention Names

Commercial vegetable juice provided by Campbell Soup Company

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• The volunteer is undergoing nicotine cessation therapy
• Laboratory values outside the reference range if determined to be clinically significant by Dr. M. Eric Gershwin
• Individuals with known salt-sensitive hypertension
• History of stage 1 high blood pressure defined as systolic > 140 and diastolic > 90, with or without use of HTN medications
• Multi-Vitamin use other than a One-A-Day essential
• Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils and unwilling to discontinue use while participating in the study
• Allergies to vegetables

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

University of California, Davis

Principal Investigators

Carl L Keen, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Nutrition

Locations

Ragle Human Nutrition Research Center (1283 Academic Surge)

Davis, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20849620 (View on PubMed)

Other Identifiers

200614971

Identifier Type: -

Identifier Source: org_study_id