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

The Effect of Orange or Apple Pomace on Digestive Health in Adults: a Randomized, Double Blind, Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Digestive Health
• Intervention / Treatment: Other: Orange Juice; Other: Orange juice + Orange Pomace; Other: Apple Juice; Other: Apple Juice and Apple Pomace

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stool frequency	Bowel habits daily diary as weekly averages. Fewer days with no stool, and higher number of stools per week would be better.	Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported GI symptoms	GI Tolerability questionnaire, 4 selections. The minimum value is Less than usual. The maximum value is Much more than usual. Pomace treament arms expected to have more GI symptoms than juice arms. Less symptoms are better than more.	Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
Stool consistency	Bristol score, 7 types of stool drawings presented in a chart from lumpy Type 1, to watery Type 7. Improved consistency would be better.	Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
Ease of stool passage	Rating scale 1 (Very easy) to 5 (Very difficult). Easier passage would be better.	Changes over 7 weeks (daily during 4 week treatment followed by daily during 3 week washout) compared to baseline (daily during 2 week run-in)
microbiota changes	Stool samples for possible explanations of mechanisms of pomace. Higher bacteria associated with fiber fermentation would be better. Species examined include F. Prau, lachnospiraceae, ruminoucoccaceae, bifidobacteria, and changes in alpha and beta diversity as measured by 16S RNA sequencing. Data pending, unknown units at this time.	Changes from baseline sample to end of treatment sample (Week 4) and end of 3 week washout sample (Week 7)
Dietary analysis	3-day diet record. Expecting higher daily fiber intake for pomace arms.	Changes from 2 week run in (baseline) to the last week of treatment (Week 4) and the last week of 3 week washout (Week 7)

Collaborators and Investigators

• Sponsor: PepsiCo Global R&D
• Investigators: Principal Investigator: Kathleen Kelley, MD, Biofortis

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 15, 2018
• Primary Completion (ACTUAL): August 30, 2019
• Study Completion (ACTUAL): August 30, 2019

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 19, 2018
• First Posted (ACTUAL): November 21, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 20, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PEP-1805

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No