DysbiosisNCT03659240
Prebiotic Effects of a Polyphenol-rich Food Product
A study testing Cranberry beverage in people with Dysbiosis, run by Iowa State University at 1 site in United States.
Trial summary
The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dysbiosis
- What is being tested?
- Cranberry beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2018to 24 Feb 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 27-35 kg/m2
- High waist circumference (men >102 cm and women >88 cm)
Who cannot join
- Cigarette smoking
- Regular intensive exercise
- Pregnancy or lactation
- Chronic diarrhea, constipation, or other gastrointestinal complaint
- Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota
- Use of medications that affect inflammation or the gut microbiota
Show all 11Show fewer
- Use of prebiotics, probiotics, synbiotics, vitamins, or other dietary supplements known to affect the gut microbiota
- Aversion to cranberries
- Food allergies
- Lactose intolerance
- Vegetarianism
Trial locations and contacts
1 site in 1 country.
United States1 site
Nutrition and Wellness Research Center
Ames, Iowa, 50011
About this study
The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.
- Conditions
- Dysbiosis
- Being tested
- Cranberry beverage, Placebo beverage
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry beverageOther
During the intervention period, research participants will consume a cranberry beverage daily.
Placebo beverageOther
During the intervention period, research participants will consume a placebo beverage daily.
| Study group | Role | What they receive |
|---|---|---|
| Cranberry beverage | Experimental | Not described Receives: Other: Cranberry beverage |
| Placebo beverage | Placebo comparator | Not described Receives: Other: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbial community composition and structure
We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage.
Measured: Changes in the fecal microbiota will be measured after a 20-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start9 Oct 2018
- Primary completion24 Feb 2019
- Study completion24 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DysbiosisStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Iowa State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wendy S. White, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659240
- Sponsor's protocol ID
- 18-303-00
- Status last verified
- Feb 2023
- First submitted
- 3 Sep 2018
- Last updated
- 2 Mar 2023
- 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 2 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Effects of a Polyphenol-rich Food Product
- ClinicalTrials.gov ID
- NCT03659240
- Acronym / sponsor ID
- 18-303-00
- Conditions
- Dysbiosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Iowa State UniversityUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 24 Feb 2019 (actual)
- Study completion
- 24 Feb 2019 (actual)
- First posted
- 6 Sep 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.
The specific aim for this project will be to investigate a cranberry beverage as a means to restore balance in terms of the relative proportions of the various bacteria that inhabit the large intestine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry beverage | Experimental | Other: Cranberry beverage |
| Placebo beverage | Placebo comparator | Other: Placebo beverage |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI 27-35 kg/m2
- High waist circumference (men >102 cm and women >88 cm)
Key exclusion criteria (11 listed)
- Cigarette smoking
- Regular intensive exercise
- Pregnancy or lactation
- Chronic diarrhea, constipation, or other gastrointestinal complaint
- Diabetes mellitus, autoimmune disease, or other chronic disease known to alter the gut microbiota
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 |
|---|---|---|
| Cranberry beverageDuring the intervention period, research participants will consume a cranberry beverage daily. | Other | Cranberry beverage |
| Placebo beverageDuring the intervention period, research participants will consume a placebo beverage daily. | Other | Placebo beverage |
Primary outcome
Fecal microbial community composition and structure
Time frame: Changes in the fecal microbiota will be measured after a 20-day intervention period
We will investigate if specific bacterial taxa are stimulated by daily consumption of a cranberry beverage.
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 2 Mar 2023.
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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.
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 Cranberry beverage in people with Dysbiosis, run by Iowa State University 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 2 inclusion and 11 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 2 Mar 2023. 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?
Fecal microbial community composition and structure (time frame: Changes in the fecal microbiota will be measured after a 20-day intervention period). 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 2 Mar 2023.