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Completed

NCT Number: NCT01161706

Clinical Investigation on the Effects of a Vegetable Juice Treatment

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.

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Key information

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ragle Human Nutrition Research Center (1283 Academic Surge)

Davis, California, 95616, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

***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

Treatment and study plan

Vegetable Juice

Other

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

Other names: Commercial vegetable juice provided by Campbell Soup Company

Primary outcomes

  1. Dietary Vegetable Intake

    Time frame: 6 and 12 weeks

  2. Dietary Nutrient Intake (vitamins & minerals)

    Time frame: 6 and 12 weeks

Secondary outcomes

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

    Time frame: 0, 6 and 12 weeks

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial

Important dates

Study start
2007
Primary completion
2007
Study completion
2009
First posted
Jul 13, 2010
Registry last updated
Jul 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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