The Effect of Fruit/Vegetable Drinks on the Human Intestine
Primary Purpose
Intestinal Bacteria Flora Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pressed Juice
Sponsored by
About this trial
This is an interventional other trial for Intestinal Bacteria Flora Disturbance focused on measuring colonic flora, microbiomes
Eligibility Criteria
Inclusion Criteria:
- Age 18-50 years of age at screen
- Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Exclusion Criteria:
- Any subject with a history of diabetes mellitus on medications, hyperlipidemia on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
- Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
- Any subject who currently uses tobacco products.
- Any history of gastrointestinal disease except for appendectomy
- No antibiotics or laxatives use during the 2 months before the study.
- Any allergies to nuts
- Any subject who is unable or unwilling to comply with the study protocol.
Sites / Locations
- UCLA Center for Human Nutrition
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
pressed juice 6 bottles
Arm Description
Subjects will consume pressed juice daily for 3 days.
Outcomes
Primary Outcome Measures
Change in Colonic Flora Composition
Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT02377063
First Posted
February 18, 2015
Last Updated
August 6, 2019
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02377063
Brief Title
The Effect of Fruit/Vegetable Drinks on the Human Intestine
Official Title
Study of the Effect of Fruit/Vegetable Based Supplementation on Microbiome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a 4 ½ week study with 20 healthy subjects (including a 2 week run-in ) . Subjects will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool samples will be collected at baseline, day 4 and day 17. The purpose of the study is to determine the effects of fruit/vegetable supplementation on colonic flora.
Detailed Description
A total of 20 subjects will be recruited from The UCLA Center for Human Nutrition/Clinical Trials Unit database, print and/or radio advertisements, UCLA campus wide e-mail, the clinicaltrials.gov website, and flyers posted on campus and in the community.
Interested persons will call a telephone number dedicated to the study where they will be instructed to leave their name and phone number. These individuals will be contacted by a study staff member, who will briefly describe the study and answer any questions to ascertain interest. If the individual is interested they will be asked to complete a brief pre-screen form over the telephone to establish eligibility. Individuals who remain interested will be invited for a screening visit. Pre-screen surveys for those not eligible will be shredded.
At screening, informed consent and HIPAA authorization will be reviewed and signed prior to any procedures being done, a medical history will be obtained. If subjects are healthy by medical history the following procedures will be conducted:
a fasting blood sample will be collected for routine safety labs (CBC and Chemistry Panel)
complete medical and medication history
brief physical examination (including vital signs, height and weight)
Dietary instruction to limit consumption of <3 servings of fruit and vegetables, vitamins and antibiotics
Dispense materials to collect fecal sample
Results will be reviewed by the study physician for compliance to inclusion and exclusion criteria and the subject will be collected and instructed whether or not they are eligible and should proceed with the stool collection after 2 weeks of dietary compliance. Once the collection is obtained subjects will be asked to return to the clinic in 24 hours.
Baseline, days 4 and 17
During the study visits, the following assessments will be conducted:
Vital signs, body weight
Collect fecal sample
Fasting blood sample
24 hour urine
Dispense materials to collect fecal sample
Dispense study supplement (Baseline and Day 17 only)
Assess for compliance of study supplement
Instructions on symptom diary
General well-being questionnaire
Subjects who are compliant will be given a 3-day supply of fruit/vegetable juice at the end of the study
Subjects will be instructed to start with their first juice upon waking or when the normally eat breakfast at intervals of approximately two hours throughout the day. Five (5) 16oz. juices and one (1) 16oz almond milk drink will be numbered and subjects will be asked to consume the product in the numbered sequence. Subjects will be instructed to avoid alcohol, caffeine, and nicotine and hydrate by drinking 8 glasses of water per day for the duration of the study. If needed, subjects will be allowed to drink a cup of herbal tea, water with lemon, almonds, cucumber or an apple during the fruit/juice supplementation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Bacteria Flora Disturbance
Keywords
colonic flora, microbiomes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
pressed juice 6 bottles
Arm Type
Other
Arm Description
Subjects will consume pressed juice daily for 3 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
Pressed Juice
Other Intervention Name(s)
Fruit/vegetable supplement
Intervention Description
Subjects will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool samples will be collected at baseline, day 4 and day 17.
Primary Outcome Measure Information:
Title
Change in Colonic Flora Composition
Description
Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline
Time Frame
baseline and day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-50 years of age at screen
Subjects must read and sign the Institutional Review Board-approved written informed consent prior to the initiation of any study specific procedures or enrollment. A subject will be excluded for any condition that might compromise the ability to give truly informed consent.
Exclusion Criteria:
Any subject with a history of diabetes mellitus on medications, hyperlipidemia on medications, or other serious medical condition, such as chronic hepatic or renal disease, bleeding disorder, congestive heart disease, chronic diarrhea disorders, myocardial infarction, coronary artery bypass graft, angioplasty within 6 months prior to screening, current diagnosis of uncontrolled hypertension (defined as systolic BP>160mmHg, diastolic BP>95mmHg), active or chronic gastrointestinal disorders, bulimia, anorexia, or endocrine diseases (except thyroid disease requiring medication) as indicated by medical history or routine physical examination.
Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
Any subject who currently uses tobacco products.
Any history of gastrointestinal disease except for appendectomy
No antibiotics or laxatives use during the 2 months before the study.
Any allergies to nuts
Any subject who is unable or unwilling to comply with the study protocol.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaoping Li, M.D., Ph.D.
Organizational Affiliation
UCLA Department of Medicine, Division of Clinical Nutrition
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Center for Human Nutrition
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Fruit/Vegetable Drinks on the Human Intestine
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