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Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults

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ClinicalTrials.gov Identifier: NCT03749031
Recruitment Status : Recruiting
First Posted : November 21, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
PepsiCo Global R&D

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Digestive Health Other: Orange juice + Orange Pomace Other: Orange Juice Other: Apple Juice and Apple Pomace Other: Apple Juice Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of Orange or Apple Pomace on Digestive Health in Adults: a Randomized, Double Blind, Controlled Trial
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : August 31, 2019

Arm Intervention/treatment
Placebo Comparator: Orange juice only
16 oz. orange juice per day for 4 weeks
Other: Orange Juice
16 oz. orange juice per day for 4 weeks

Experimental: orange juice + orange Pomace
16 oz. orange juice + orange Pomace per day for 4 weeks
Other: Orange juice + Orange Pomace
16 oz. orange juice + orange Pomace per day for 4 weeks

Placebo Comparator: Apple juice only
16 oz. apple juice per day for 4 weeks
Other: Apple Juice
16 oz. apple juice per day for 4 weeks

Experimental: Apple Juice + Apple Pomace
16 oz. apple juice + apple Pomace per day for 4 weeks
Other: Apple Juice and Apple Pomace
16 oz. apple juice and apple Pomace per day for 4 weeks




Primary Outcome Measures :
  1. stool frequency [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. self reported GI symptoms [ Time Frame: 4 weeks ]
  2. Diary Intake [ Time Frame: 4 weeks ]
  3. microbiota changes [ Time Frame: 4 weeks ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03749031


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

Locations
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United States, Illinois
BioFortis Recruiting
Addison, Illinois, United States, 60101
Contact: Kathleen Kelley, MD    630-617-2000    Kathy.Kelley-Garvin@mxns.com   
Sponsors and Collaborators
PepsiCo Global R&D
Investigators
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Principal Investigator: Kathleen Kelley, MD BioFortis

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Responsible Party: PepsiCo Global R&D
ClinicalTrials.gov Identifier: NCT03749031     History of Changes
Other Study ID Numbers: PEP-1805
First Posted: November 21, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No