Intestinal Bacteria Flora Disturbance
Conditions
Keywords
colonic flora, microbiomes
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.
Interventions
DIETARY_SUPPLEMENTPressed Juice
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.
Sponsors
University of California, Los Angeles
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Colonic Flora Composition | baseline and day 4 | Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline |
Countries
United States
Participant flow
Recruitment details
UCLA IRB-approved flyers were posted around campus. Interested subjects who respond to the approved flyers called the research site and a coordinator conducted a screening by utilizing the screening script. Eligible subjects will be scheduled for a screening visit began 5/12/2015- 7/7/2015.
Participants by arm
| Arm | Count |
|---|---|
| Pressed Juice Subjects will consume pressed juice supplementation for 3 days
Pressed Juice: 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. | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-compliance | 5 |
Baseline characteristics
| Characteristic | Pressed Juice |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Change in Colonic Flora Composition
Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline
Time frame: baseline and day 4
Population: All participants for whom colonic flora composition were measured at baseline and day 4.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mixed Fruit and Vegetable Juice 6 Bottles | Change in Colonic Flora Composition | Phylum Firmicutes at day 0 | 52.4 percentage of total bacteria | Standard Error 3.9 |
| Mixed Fruit and Vegetable Juice 6 Bottles | Change in Colonic Flora Composition | Phylum Firmicutes at day 4 | 41.2 percentage of total bacteria | Standard Error 3.5 |
| Mixed Fruit and Vegetable Juice 6 Bottles | Change in Colonic Flora Composition | Phylum Bacteroidetes at day 0 | 41.4 percentage of total bacteria | Standard Error 3.8 |
| Mixed Fruit and Vegetable Juice 6 Bottles | Change in Colonic Flora Composition | Phylum Bacteroidetes at day 4 | 51.9 percentage of total bacteria | Standard Error 3.5 |
Comparison: Comparison was made to day 4 minus day 0 (baseline) change of phylum Firmicutes after juice consumptionp-value: 0.014ANOVA
Comparison: Comparison was made to day 4 minus day 0 (baseline) change of phylum Bacteroidetes after juice consumptionp-value: 0.026ANOVA