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

Digestive Health Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749031
• Other study ID #: PEP-1805
• Status: Completed
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: December 2019
• Source: PepsiCo Global R&D
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Digestive Health

Intervention

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

Locations

Country	Name	City	State
United States	BioFortis	Addison	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
PepsiCo Global R&D

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)