Food SelectionNCT02565472
Effects of Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects
A study testing White grape juice and Apple juice in people with Food Selection, run by University of Minnesota at 1 site in United States.
Trial summary
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of two types of juice. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Selection
- What is being tested?
- White grape juice and Apple juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2015
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18-65 Body mass index between 18-29 kg/m2 Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures
Who cannot join
- • Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
- Smoker
- Not a regular breakfast or eater
- Self-reported history of a past or current gastrointestinal disease
- High fiber eater (≥3 servings of high fiber foods per day)
- Concurrent or recent (within 30 days) participation in an intervention trial
- Recent weight fluctuations
- Allergies to any of the test products
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Saint Paul, Minnesota, 55108
About this study
Official title: Effect of a White Grape Juice Compared to Apple Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of two types of juice. This double-blind crossover study requires participants to arrive to the lab 12 hours fasted, consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over the next 3 hours. Subjects will be asked to complete additional questionnaires at 12 and 24 hours post consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior to their scheduled visit times to assure compliance.
- Conditions
- Food Selection
- Being tested
- White grape juice, Apple juice
- Medical subject headings
- Food Preferences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White grape juiceOther
Apple juiceOther
| Study group | Role | What they receive |
|---|---|---|
| Apple Juice | Experimental | 12 oz apple juice Receives: Other: Apple juice |
| Grape Juice | Experimental | 12 oz grape juice Receives: Other: White grape juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal tolerance from baseline
Subjects will answer a 7 symptom questionnaire regarding the intensity of gastrointestinal symptoms experienced following juice consumption. Questionnaire is adapted from the validated Bovenschen gastrointestinal tolerance questionnaire. Questionnaire is to be completed at the following time points: baseline, 30 min, 60 min, 90 min, 120 min, 180 min, 12 hours, 24 hours.
Measured: 24 hours
Secondary outcomes (1)
Change in Breath Hydrogen from baseline
Patients will be asked to exhale a full breath into a sample collection bag. The breath samples will be extracted and measured using the Quintron BreathTracker Analyzer at time points: baseline, 60 min, 120 min. This will be a marker of carbohydrate fermentation in the colon.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food SelectionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565472
- Sponsor's protocol ID
- 1508M77407
- Status last verified
- Feb 2016
- First submitted
- 22 Sep 2015
- Last updated
- 24 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a White Grape Juice Compared to Apple Juice on Gastrointestinal Tolerance and Breath Hydrogen Response in Human Subjects
- ClinicalTrials.gov ID
- NCT02565472
- Acronym / sponsor ID
- 1508M77407
- Conditions
- Food Selection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- First posted
- 1 Oct 2015 (estimated)
- 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.
The goal of this study is to determine subjective gastrointestinal tolerance response and differences in breath hydrogen response following the consumption of two types of juice. This double-blind crossover study requires participants to arrive to the lab 12 hours fasted, consume 12 oz of juice and complete gastrointestinal tolerance questionnaires as well as produce samples for breath hydrogen analysis at various time points over the next 3 hours. Subjects will be asked to complete additional questionnaires at 12 and 24 hours post consumption, from home. Subjects will also be asked to keep a food record for 24 hours prior to their scheduled visit times to assure compliance.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apple Juice | Experimental | Other: Apple juice12 oz apple juice |
| Grape Juice | Experimental | Other: White grape juice12 oz grape juice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Between the ages of 18-65 Body mass index between 18-29 kg/m2 Demonstrates spoken and written English literacy and able to provide written, informed consent after review of study protocol and procedures
Key exclusion criteria (8 listed)
- • Use of enemas, laxatives, proton pump inhibitors, or antibiotics within the past 3 months
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 |
|---|---|---|
| White grape juice | Other | Grape Juice |
| Apple juice | Other | Apple Juice |
Primary outcome
Change in gastrointestinal tolerance from baseline
Time frame: 24 hours
Subjects will answer a 7 symptom questionnaire regarding the intensity of gastrointestinal symptoms experienced following juice consumption. Questionnaire is adapted from the validated Bovenschen gastrointestinal tolerance questionnaire. Questionnaire is to be completed at the following time points: baseline, 30 min, 60 min, 90 min, 120 min, 180 min, 12 hours, 24 hours.
1 secondary outcome
Change in Breath Hydrogen from baseline
Time frame: 2 hours
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 24 Feb 2016.
Related trials for Food Selection
Not yet recruiting
Exploring the Influence of Glucagon-like Peptide -1 (GLP-1) Medications on Food Cravings, Food Selection, and Food Intake Following Exposure to Food Advertisements
GLP - 1
Recruiting
Influence of Social Media Ads on Food Choice - Master Protocol
Food Selection, Food Choices
Not yet recruiting
Optimization Trial to Empower sElection of Nutritious Foods
Food Insecurity, Healthy Eating
Not yet recruiting
Food Menu Labelling Effects on Individuals With Eating Disorders and Other Mental Health Conditions.
Food Labelling, Eating Behaviour
RecruitingObservational study
Fostering Self-Empowerment in CKD Patients Through Food Choice Mapping
CKD, Chronic Kidney Disease (Stages 3b-5)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing White grape juice and Apple juice in people with Food Selection, run by University of Minnesota 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 1 inclusion and 8 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 24 Feb 2016. 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. 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?
Change in gastrointestinal tolerance from baseline (time frame: 24 hours). 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 24 Feb 2016.