The Effect of Fruit/Vegetable Drinks on the Human Intestine

Completed · Not applicable

Conditions studied: Intestinal Bacteria Flora Disturbance

In brief

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.

Key facts

Study ID

NCT02377063

Run by

University of California, Los Angeles

People needed

25

Starts

2015-04-01

Expected to finish

2015-08-01

Last updated by the study team

2019-09-09

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

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.

Where it is running

• UCLA Center for Human Nutrition — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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