Intestinal Bacteria Flora DisturbanceNCT02377063
The Effect of Fruit/Vegetable Drinks on the Human Intestine
A study testing Pressed Juice in people with Intestinal Bacteria Flora Disturbance, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Bacteria Flora Disturbance
- What is being tested?
- Pressed Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Center for Human Nutrition
Los Angeles, California, 90095
About this study
Official title: Study of the Effect of Fruit/Vegetable Based Supplementation on Microbiome
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.
Read the 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.
- Conditions
- Intestinal Bacteria Flora Disturbance
- Being tested
- Pressed Juice
- Keywords
- colonic flora, microbiomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pressed JuiceDietary supplement
Also called Fruit/vegetable supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| pressed juice 6 bottles | Other | Subjects will consume pressed juice daily for 3 days. Receives: Dietary Supplement: Pressed Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Colonic Flora Composition
Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline
Measured: baseline and day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Intestinal Bacteria Flora DisturbanceStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, M.D., Ph.D., Principal investigator, UCLA Department of Medicine, Division of Clinical Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377063
- Sponsor's protocol ID
- 15-000274
- Status last verified
- Aug 2019
- First submitted
- 18 Feb 2015
- Last updated
- 9 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effect of Fruit/Vegetable Based Supplementation on Microbiome
- ClinicalTrials.gov ID
- NCT02377063
- Acronym / sponsor ID
- 15-000274
- Conditions
- Intestinal Bacteria Flora Disturbance
- Keywords
- colonic flora, microbiomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 3 Mar 2015 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pressed juice 6 bottles | Other | Dietary Supplement: Pressed JuiceSubjects will consume pressed juice daily for 3 days. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pressed JuiceAlso: Fruit/vegetable supplementSubjects 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. | Dietary supplement | pressed juice 6 bottles |
Primary outcome
Change in Colonic Flora Composition
Time frame: baseline and day 4
Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, M.D., Ph.D. principal investigator
UCLA Department of Medicine, Division of Clinical Nutrition
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pressed Juice in people with Intestinal Bacteria Flora Disturbance, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Colonic Flora Composition (time frame: baseline and day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2019.