Skip to main content
OpenTrials
Completed

NCT Number: NCT03749031

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Digestive Health

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioFortis

Addison, Illinois, 60101, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Orange juice + orange pomace

Other

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

Orange juice

Other

16 oz. orange juice per day for 4 weeks

Apple Juice and Apple Pomace

Other

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

Apple juice

Other

16 oz. apple juice per day for 4 weeks

Primary outcomes

  1. stool frequency

    Time frame: 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)

    Bowel habits daily diary as weekly averages. Fewer days with no stool, and higher number of stools per week would be better.

Secondary outcomes

  1. Self-reported GI symptoms

    Time frame: 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)

    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.

  2. Stool consistency

    Time frame: 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)

    Bristol score, 7 types of stool drawings presented in a chart from lumpy Type 1, to watery Type 7. Improved consistency would be better.

  3. Ease of stool passage

    Time frame: 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)

    Rating scale 1 (Very easy) to 5 (Very difficult). Easier passage would be better.

  4. microbiota changes

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

    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.

  5. Dietary analysis

    Time frame: 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)

    3-day diet record. Expecting higher daily fiber intake for pomace arms.

Sponsors and collaborators

Lead sponsor

PepsiCo Global R&D

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 21, 2018
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.