Addison, Illinois 60101


Purpose:

This is a randomized crossover intervention designed to evaluate effects of daily intake of beverages containing orange or apple Pomace on gastrointestinal function as measured by stool frequency. Additional outcomes will include aspects of digestive health and self-reported GI symptoms and dietary intake as well as analysis of gut microbiota.


Criteria:

Inclusion Criteria: - Healthy males and females 18-60 years old - Willing and able to consume 16 oz. of orange or apple beverage per day for 4 week periods - Willing to maintain usual diet, smoking status, physical activity pattern, supplements and meds Exclusion Criteria: - Food allergies or sensitivities to ingredients in study beverages - Presence or history of GI condition, endocrine (including diabetes), cardiovascular disease or other disease or condition that could interfere in the interpretation of the study results in the opinion of the Investigator. - Extreme dietary habits including vegetarian, vegan or Atkins diet - Females or are pregnant, planning to become pregnant or breast feeding during the study period.


NCT ID:

NCT03749031


Primary Contact:

Principal Investigator
Kathleen Kelley, MD
BioFortis

Kathleen Kelley, MD
Phone: (630) 617-2000
Email: Kathy.Kelley-Garvin@mxns.com


Backup Contact:

Email: Kathy.Kelley-Garvin@mxns.com
Kathleen Kelley, MD
Phone: 630-617-2000


Location Contact:

Addison, Illinois 60101
United States

Kathleen Kelley, MD
Phone: 630-617-2000
Email: Kathy.Kelley-Garvin@mxns.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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