Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-26 @ 1:16 PM
Study NCT ID:
NCT01161706
Status:
COMPLETED
Last Update Posted:
2010-07-13
First Post:
2010-07-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Investigation on the Effects of a Vegetable Juice Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067030', 'term': 'Fruit and Vegetable Juices'}], 'ancestors': [{'id': 'D001628', 'term': 'Beverages'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-07-12', 'studyFirstSubmitDate': '2010-07-12', 'studyFirstSubmitQcDate': '2010-07-12', 'lastUpdatePostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary Vegetable Intake', 'timeFrame': '6 and 12 weeks'}, {'measure': 'Dietary Nutrient Intake (vitamins & minerals)', 'timeFrame': '6 and 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Selected Cardiovascular Risk Factors (lipids, blood pressure, TBARS/oxidative stress)', 'timeFrame': '0, 6 and 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['vegetable juice', 'cardiovascular', 'blood pressure'], 'conditions': ['Vegetables', 'Cardiovascular Disease', 'Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '20849620', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "\\*\\*\\*Inclusion Criteria\\*\\*\\*\n\n* Age 40 to 65 yrs\n* Subject's body mass index is between 18.5 - 34.9 kg/m2\n* Subject is willing and able to comply with the study protocols\n* Subject is willing to consume a vegetable-based beverage daily for three months\n\n\\*\\*\\*Exclusion Criteria\\*\\*\\*\n\n* Physical signs of health impairment\n* Uncontrolled diabetes or hypertension\n* Pregnant or lactating\n* Active tuberculosis or lung disease (i.e. COPD)\n* Renal or Liver disease\n* Heart Disease, which includes Cardiovascular events and Stroke\n* Cushing's syndrome\n* Exercise trained individuals\n* History of psychiatric disorders i.e. schizophrenia or bi-polar or depression treated with antidepressants within the last 1 year\n* Anxiety medications\n* Use of MAOI inhibitors within the last 1 year (e.g., phenelzine (Nardil), tranylcypromine (Parnate), etc.)\n* Quality of life score of 21 or above\n* 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\n* Asthma (can be worsened by mild to moderate food allergies)\n* Indications of substance or alcohol abuse within the last 3 years\n* The volunteer is undergoing nicotine cessation therapy\n* Laboratory values outside the reference range if determined to be clinically significant by Dr. M. Eric Gershwin\n* Individuals with known salt-sensitive hypertension\n* History of stage 1 high blood pressure defined as systolic \\> 140 and diastolic \\> 90, with or without use of HTN medications\n* Multi-Vitamin use other than a One-A-Day essential\n* Use of herbal or plant-based supplements; omega-3 fatty acids, and fish oils and unwilling to discontinue use while participating in the study\n* Allergies to vegetables"}, 'identificationModule': {'nctId': 'NCT01161706', 'briefTitle': 'Clinical Investigation on the Effects of a Vegetable Juice Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'The Use of a Commercial Vegetable Juice as a Practical Means to Increase Vegetable Intake: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '200614971'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': '0 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet'}, {'type': 'EXPERIMENTAL', 'label': '8 fluid ounces vegetable juice', 'description': '8 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet', 'interventionNames': ['Other: Vegetable Juice']}, {'type': 'EXPERIMENTAL', 'label': '16 fluid ounces vegetable juice', 'description': '16 fluid ounces vegetable juice plus dietary education on the DASH (Dietary Approaches to Stop Hypertension) diet', 'interventionNames': ['Other: Vegetable Juice']}], 'interventions': [{'name': 'Vegetable Juice', 'type': 'OTHER', 'otherNames': ['Commercial vegetable juice provided by Campbell Soup Company'], 'description': 'Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.', 'armGroupLabels': ['16 fluid ounces vegetable juice', '8 fluid ounces vegetable juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'Ragle Human Nutrition Research Center (1283 Academic Surge)', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}], 'overallOfficials': [{'name': 'Carl L Keen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Nutrition'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Sonia F. Shenoy, Postdoctoral Scholar', 'oldOrganization': 'University of California, Davis'}}}}