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

Study Overview
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Brief Summary
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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.

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

Conditions
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Digestive Health

Intervention / Treatment
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* Other: Orange juice + Orange Pomace
* Other: Orange Juice
* Other: Apple Juice and Apple Pomace
* Other: Apple Juice


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Orange juice only<br>16 oz. orange juice per day for 4 weeks | Other: Orange Juice<br>* 16 oz. orange juice per day for 4 weeks<br>|
| Experimental: orange juice + orange Pomace<br>16 oz. orange juice + orange Pomace per day for 4 weeks | Other: Orange juice + Orange Pomace<br>* 16 oz. orange juice + orange Pomace per day for 4 weeks<br>|
| Placebo Comparator: Apple juice only<br>16 oz. apple juice per day for 4 weeks | Other: Apple Juice<br>* 16 oz. apple juice per day for 4 weeks<br>|
| Experimental: Apple Juice + Apple Pomace<br>16 oz. apple juice + apple Pomace per day for 4 weeks | Other: Apple Juice and Apple Pomace<br>* 16 oz. apple juice and apple Pomace per day for 4 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) |