Digestive HealthNCT03749031
Effects of Beverages Containing Orange or Apple Pomace on Digestive Health in Adults
A study testing Orange juice + Orange Pomace, Orange Juice and Apple Juice and Apple Pomace in people with Digestive Health, run by PepsiCo Global R&D at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Digestive Health
- What is being tested?
- Orange juice + Orange Pomace, Orange Juice and Apple Juice and Apple Pomace
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2018to 30 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Orange or Apple Pomace on Digestive Health in Adults: a Randomized, Double Blind, Controlled Trial
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.
- Conditions
- Digestive Health
- Being tested
- Orange juice + Orange Pomace, Orange Juice, Apple Juice and Apple Pomace, Apple Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange juice + Orange PomaceOther
16 oz. orange juice + orange Pomace per day for 4 weeks
Orange JuiceOther
16 oz. orange juice per day for 4 weeks
Apple Juice and Apple PomaceOther
16 oz. apple juice and apple Pomace per day for 4 weeks
Apple JuiceOther
16 oz. apple juice per day for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Orange juice only | Placebo comparator | 16 oz. orange juice per day for 4 weeks Receives: Other: Orange Juice |
| orange juice + orange Pomace | Experimental | 16 oz. orange juice + orange Pomace per day for 4 weeks Receives: Other: Orange juice + Orange Pomace |
| Apple juice only | Placebo comparator | 16 oz. apple juice per day for 4 weeks Receives: Other: Apple Juice |
| Apple Juice + Apple Pomace | Experimental | 16 oz. apple juice + apple Pomace per day for 4 weeks Receives: Other: Apple Juice and Apple Pomace |
What is being measured
The primary outcome is the main question the study is designed to answer.
stool frequency
Bowel habits daily diary as weekly averages. Fewer days with no stool, and higher number of stools per week would be better.
Measured: 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 outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2018
- Study start15 Oct 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- PepsiCo Global R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathleen Kelley, MD, Principal investigator, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03749031
- Sponsor's protocol ID
- PEP-1805
- Status last verified
- Dec 2019
- First submitted
- 19 Nov 2018
- Last updated
- 20 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Orange or Apple Pomace on Digestive Health in Adults: a Randomized, Double Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT03749031
- Acronym / sponsor ID
- PEP-1805
- Conditions
- Digestive Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- PepsiCo Global R&DIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 21 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Orange juice only | Placebo comparator | Other: Orange Juice16 oz. orange juice per day for 4 weeks |
| orange juice + orange Pomace | Experimental | Other: Orange juice + Orange Pomace16 oz. orange juice + orange Pomace per day for 4 weeks |
| Apple juice only | Placebo comparator | Other: Apple Juice16 oz. apple juice per day for 4 weeks |
| Apple Juice + Apple Pomace | Experimental | Other: Apple Juice and Apple Pomace16 oz. apple juice + apple Pomace per day for 4 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orange juice + Orange Pomace16 oz. orange juice + orange Pomace per day for 4 weeks | Other | orange juice + orange Pomace |
| Orange Juice16 oz. orange juice per day for 4 weeks | Other | Orange juice only |
| Apple Juice and Apple Pomace16 oz. apple juice and apple Pomace per day for 4 weeks | Other | Apple Juice + Apple Pomace |
| Apple Juice16 oz. apple juice per day for 4 weeks | Other | Apple juice only |
Primary outcome
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.
5 secondary outcomes
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)
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)
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)
microbiota changes
Time frame: Changes from baseline sample to end of treatment sample (Week 4) and end of 3 week washout sample (Week 7)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kathleen Kelley, MD principal investigator
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orange juice + Orange Pomace, Orange Juice and Apple Juice and Apple Pomace in people with Digestive Health, run by PepsiCo Global R&D at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2019.