The Effect of Fruit/Vegetable Drinks on the Human Intestine

NCT02377063 | Completed Results

• 1 other identifier: 15-000274
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Bacteria Flora Disturbance

Keywords

colonic flora; microbiomes

Outcome Measures

Primary Outcomes (1)

• Change in Colonic Flora Composition

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

  baseline and day 4

Study Arms (1)

pressed juice 6 bottles

OTHER

Subjects will consume pressed juice daily for 3 days.

Dietary Supplement: Pressed Juice

Interventions

Pressed Juice DIETARY_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.

Also known as: Fruit/vegetable supplement

pressed juice 6 bottles

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

UCLA Center for Human Nutrition

Los Angeles, California, 90095, United States

Location

MeSH Terms

Interventions

Fruit

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Limitations and Caveats

The study did not address the mechanistic aspect of juice-induced colonic flora composition change.

Results Point of Contact

• Title: Zhaoping Li, MD, PhD - Principal Investigator
• Organization: UCLA Center for Human Nutrition

zli@mednet.ucla.edu

310-206-1987

Study Officials

• Zhaoping Li, M.D., Ph.D.

  UCLA Department of Medicine, Division of Clinical Nutrition

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 18, 2015
• First Posted: March 3, 2015
• Study Start: April 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 9, 2019
• Results First Posted: September 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)