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

NCT03749031 | Completed

• 1 other identifier: PEP-1805
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Digestive Health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self-reported GI symptoms

  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

  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

  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

  Changes from baseline sample to end of treatment sample (Week 4) and end of 3 week washout sample (Week 7)

• Dietary analysis

  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)

Study Arms (4)

Orange juice only

PLACEBO COMPARATOR

16 oz. orange juice per day for 4 weeks

Other: Orange Juice

orange juice + orange Pomace

EXPERIMENTAL

16 oz. orange juice + orange Pomace per day for 4 weeks

Other: Orange juice + Orange Pomace

Apple juice only

PLACEBO COMPARATOR

16 oz. apple juice per day for 4 weeks

Other: Apple Juice

Apple Juice + Apple Pomace

EXPERIMENTAL

16 oz. apple juice + apple Pomace per day for 4 weeks

Other: Apple Juice and Apple Pomace

Interventions

Orange juice + Orange Pomace OTHER

16 oz. orange juice + orange Pomace per day for 4 weeks

orange juice + orange Pomace

Orange Juice OTHER

16 oz. orange juice per day for 4 weeks

Orange juice only

Apple Juice and Apple Pomace OTHER

16 oz. apple juice and apple Pomace per day for 4 weeks

Apple Juice + Apple Pomace

Apple Juice OTHER

16 oz. apple juice per day for 4 weeks

Apple juice only

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• PepsiCo Global R&D: lead

Study Sites (1)

BioFortis

Addison, Illinois, 60101, United States

Location

Study Officials

• Kathleen Kelley, MD

  BioFortis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2018
• First Posted: November 21, 2018
• Study Start: October 15, 2018
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (1)