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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Orange juice only | Placebo Comparator | 16 oz. orange juice per day for 4 weeks |
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| orange juice + orange Pomace | Experimental | 16 oz. orange juice + orange Pomace per day for 4 weeks |
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| Apple juice only | Placebo Comparator | 16 oz. apple juice per day for 4 weeks |
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| Apple Juice + Apple Pomace | Experimental | 16 oz. apple juice + apple Pomace per day for 4 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orange juice + Orange Pomace | Other | 16 oz. orange juice + orange Pomace per day for 4 weeks |
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| 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) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Kelley, MD | BioFortis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BioFortis | Addison | Illinois | 60101 | United States |
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| Orange Juice | Other | 16 oz. orange juice per day for 4 weeks |
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| Apple Juice and Apple Pomace | Other | 16 oz. apple juice and apple Pomace per day for 4 weeks |
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| Apple Juice | Other | 16 oz. apple juice per day for 4 weeks |
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| 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) |