Digestive Health
Conditions
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.
Interventions
16 oz. orange juice + orange Pomace per day for 4 weeks
OTHEROrange Juice
16 oz. orange juice per day for 4 weeks
OTHERApple Juice and Apple Pomace
16 oz. apple juice and apple Pomace per day for 4 weeks
OTHERApple Juice
16 oz. apple juice per day for 4 weeks
Sponsors
PepsiCo Global R&D
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stool frequency | 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
| 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) | Bristol score, 7 types of stool drawings presented in a chart from lumpy Type 1, to watery Type 7. Improved consistency would be better. |
| 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) | Rating scale 1 (Very easy) to 5 (Very difficult). Easier passage would be better. |
| microbiota changes | 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. |
| 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) | 3-day diet record. Expecting higher daily fiber intake for pomace arms. |
Countries
United States
Outcome results
None listed