Clinical trial NCT02377063: 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
Overall status: COMPLETED
Phase: NA
Conditions: Intestinal Bacteria Flora Disturbance
Keywords: colonic flora
microbiomes
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-50 years of age at screen
2. 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:

1. 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.
2. Any subject with a screening laboratory value outside of the laboratory normal range that is considered clinically significant for study participation by the investigator.
3. Any subject who currently uses tobacco products.
4. Any history of gastrointestinal disease except for appendectomy
5. No antibiotics or laxatives use during the 2 months before the study.
6. Any allergies to nuts
7. Any subject who is unable or unwilling to comply with the study protocol.

Primary outcomes:
measure: Change in Colonic Flora Composition
timeFrame: baseline and day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Center for Human Nutrition
state: California
Study officials:
affiliation: UCLA Department of Medicine, Division of Clinical Nutrition
name: Zhaoping Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: