Trial Outcomes & Findings for The Effect of Fruit/Vegetable Drinks on the Human Intestine (NCT NCT02377063)

NCT ID: NCT02377063

Last Updated: 2019-09-09

Results Overview

Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 25 participants
• Primary outcome timeframe: baseline and day 4
• Results posted on: 2019-09-09

Participant Flow

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.

Participant milestones

Measure	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.
Overall Study STARTED	25
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	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.
Overall Study Non-compliance	5

Baseline Characteristics

Five subjects who did not provide fecal samples were excluded from the analysis.

Baseline characteristics by cohort

Measure	Pressed Juice n=25 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants • Five subjects who did not provide fecal samples were excluded from the analysis.
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants • Five subjects who did not provide fecal samples were excluded from the analysis.
Age, Categorical >=65 years	0 Participants n=5 Participants • Five subjects who did not provide fecal samples were excluded from the analysis.
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	10 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and day 4

Population: All participants for whom colonic flora composition were measured at baseline and day 4.

Changes in microbial count (%) were calculated as the values at day 4 minus the values at baseline

Outcome measures

Measure	Mixed Fruit and Vegetable Juice 6 Bottles n=20 Participants All participants consumed 6 bottles of mixed fruit and vegetable juice daily for 3 days.
Change in Colonic Flora Composition Phylum Firmicutes at day 0	52.4 percentage of total bacteria Standard Error 3.9
Change in Colonic Flora Composition Phylum Firmicutes at day 4	41.2 percentage of total bacteria Standard Error 3.5
Change in Colonic Flora Composition Phylum Bacteroidetes at day 0	41.4 percentage of total bacteria Standard Error 3.8
Change in Colonic Flora Composition Phylum Bacteroidetes at day 4	51.9 percentage of total bacteria Standard Error 3.5

Adverse Events

Pressed Juice

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Zhaoping Li, MD, PhD - Principal Investigator

UCLA Center for Human Nutrition

Phone: 310-206-1987

Email: zli@mednet.ucla.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place