Fecal MicrobiotaNCT02677649
Microbiota Diversity and Composition and Polyphenol Bioavailability
A study testing cranberry in people with Fecal Microbiota, run by Tufts University at 1 site in United States.
Trial summary
Composition and diversity of intestinal microbiota that are subject to the influence of diet have a significant impact on health in the gut and whole body via complex interactions between food constituents, bacteria, and host. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Fecal Microbiota
- What is being tested?
- cranberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to Aug 2016
- 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 20 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 20-55 y
- BMI between 18.5-29.9 kg/m2
- Bowel movement ≥3 times/wk
- Consume ≥3 servings of fruits and vegetables daily on average
- Willing to consume animal based diets for ≥10 days
- Willing to consume freeze-dried whole cranberry powder
- Willing to not take prebiotics and probiotics during the trial
- Do not have allergic reaction to cranberries
Who cannot join
- Colonoscopy 2 mo prior to their enrollment or scheduled during the study
- No antibiotic medications or drugs known to influence fecal microbiota were taken or used 3 mo before the study
- History of a bilateral mastectomy
- History of autoimmune disorders (rheumatoid arthritis, lupus, multiple sclerosis, vitiligo, psoriasis)
- Consume <3 servings of fruits and vegetables daily one average
- Gastrointestinal diseases, conditions, or medications influencing gastrointestinal absorption including active peptic ulcer disease or inflammatory bowel disease which will be found based on the self-report during the screening visit
Show all 22Show fewer
- Regular use of any acid-lowering medications (≥3 times/week)
- Use of ≥14/wk serving of alcohol (168 oz beer, 56 oz wine, 14 oz hard liquor)
- Intend to be pregnant, pregnancy, and breastfeeding
- Infrequent (<3/wk) or excessive (>3/d) number of regular bowel movements
- Active treatment for cancer (except non-melanom skin cancer) and cardiovascular disease of any type >1 y
- Having diabetes and/or receiving medications for diabetic condition, which will be found based on the self-report during the screening visit
- Thyroid disease unstable or medication adjustments in past 6 months, which will be found based on the self-report during the screening visit
- Values of standard blood biochemistries are unacceptable for the study based on study physician's discretion
- vegetarians and vegans, unwillingness or inability to consume animal-based foods including chicken, turkey, beef, eggs, cheese, other milk products, etc. Allergy to eggs or milk/dairy products.
- Use anticoagulants, such as heparin, warfarin (coumadin) in past 6 months
- On or planning to be on a weight loss regimen
- Regular use of any dietary supplements containing vitamins, minerals, herbal or other plant-based preparations, fish oil supplements (including cod liver oil) or homeopathic remedies; however, subjects who are willing to refrain from the use of these supplements at enrollment and throughout the entire study may be considered eligible
- Use of monoamine oxidase inhibitors (MAOIs)
- Glomerular filtration rate (GFR) <60 mL/min/1.73 m2
- Total cholesterol (TC) >250 mg/dL
- Total triglycerides (TG) >300 mg/dL
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Microbiota Diversity and Composition and Polyphenol Bioavailability: a Controlled Feeding Trial With a Plant Free Diet Containing Whole Cranberry Powder
Composition and diversity of intestinal microbiota that are subject to the influence of diet have a significant impact on health in the gut and whole body via complex interactions between food constituents, bacteria, and host. Polyphenols are poorly absorbed in the upper gastrointestinal tract and reach the colon, where they may have a reciprocal relationship with microbiota. Because how polyphenols mediate gut health and reduce risk for other pathogenesis remains to be elucidated, we propose to conduct a pilot controlled feeding study to examine the impact of polyphenols and other constituents in the free dried whole cranberry powder (FWCP) on composition and diversity of gut microbiota, as well as to substantiate bioavailability of cranberry polyphenols. The central hypothesis underlying the proposed research is that FWCP polyphenols will diminish the magnitude of a plant food free diet induced increase in Alistipes, Bilophila and Bacteroides and will increase Enterococcus, Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale groups. The proposed research is novel as no study has examined the specific impact of FWCP polyphenols incorporated into a plant food free diet on gut microbiota. This proposed study is innovative because the positive results will demonstrate with a high degree of confidence that the impact of FWCP constituents on production of beneficial short chain fatty acids, carcinogenic bile acids, and atherogenic trimethylamine. The results generated from the study using a plant food free dietary regimen as the background diet will provide definite proof on microbial modulating actions of FWCP, inform mechanism of actions in urinary tract infection (UTI), and be used to formulate messages in consumer communications for gut health.
Read the detailed description
Investigators propose conducting a randomized, controlled feeding, crossover trial in 10 adults who have a regular bowel movement (≥5 times/wk) and are willing to consume a diet free of plant foods. The trial will include two 5-d intervention phases with a 2-wk washout period between crossovers. All meals will be provided to subjects during the intervention phases. Subjects will be randomly assigned to receive either Con or FWCP diet containing 30 gram matched placebo or FWCP. The dose is selected in order to provide sufficient amounts of flavonoid and PAC that can be comparable to the average flavonoid and PAC intake at 157 mg and 95 mg/d, respectively in US. The plant food free diet will be formulated to contain only animal based ingredients. All meals will be designed and overseen by Helen Rasmussen, PhD, RD, and be prepared in the kitchen of the Metabolic Research Unit. Packed frozen meals will be provided to subjects to consume at home or work. Coffee, tea, and other plant-based beverages will not be allowed during the intervention phases.
All subjects will be required to provide their informed consent prior to enrolling in the study. Individuals will be screened for study eligibility according to the exclusion criteria, as followed: 1) no antibiotic medications or drugs known to influence fecal microbiota were taken 3 mo before the study; 2) active treatment for doctor diagnosed diseases, such as cancer, cardiovascular diseases, gastrointestinal diseases; 3) regular use of any dietary supplements; 4) colonoscopy 2 mo prior to their enrollment or scheduled during the study; 5) values of standard blood biochemistries are critically abnormal based on study physician's discretion; and 6) use of ≥14/wk serving of alcohol. Subjects who meet all other eligibility criteria and have values of blood biochemistries within normal ranges will be asked to participate in the study.
During the trial, eligible subjects will be required to attend 1 screening visit and 9 study visits over 5-7 wks. At the end of Visits 2 and 6, subjects will receive the randomly assigned frozen meals and begin consuming the study meals for 5 d. Subjects may consume the study meals ≥5 da until the post-intervention stool sample is collected. The whole stool sample will be placed in a sealed bag and then in a cooler with ice packs and transported to the MRU within 24 h. Morning spot urine and 30 mL fasted blood as well as all other clinical data will be collected before and after each intervention phase. All collected samples will be stored at -80 degree C until uses.
The sample size of the human trial was estimated based on the effect of FWCP on the plant food free diet induced increase in bile tolerant bacteria and on the increase in Enterococcus, Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale. Since there is no data in the literature illustrating the effect of FWCP on bile tolerant bacteria for power calculation, investigators will employ in the proposed crossover controlled feeding trial 10 subjects to test our hypothesis.
Fecal DNA will be extracted by enzymatic digestion and bead-beating steps followed by the use of QIAamp Stool DNA Mini Kit (Qiagen). 16S rRNA gene amplicons will be generated from the extracted DNA using PCR with a barcoded primer set targeted to the V4 variable region. Amplicons will be sequenced on an Illumina ® MiSeq Sequencer at the Tufts University Core Facility which is directed by Dr. Anne Kane. Microbiota Analysis will be performed using Qiime v 1.7. Operational taxonomic units will be generated using UClust. Alpha and beta diversity parameters will be calculated using Qiime. Urinary flavonoids and phenolic acids will be determined by our routine HPLC-electrochemical detection method. Anthocyanins and their glucuronidate metabolites in urine will be quantified by a LC-MS/MS assay investigators use routinely. Fecal short chain fatty acids will be determined using a GC-MS method that has been established in our laboratory. The pH value in the fecal water of the feces will be determined using a pH meter after centrifugation. Individual bile acids in feces will be determined using a LC-QTOF-MS method. TMA in feces will be determined using a spectrophotometric assay.
- Conditions
- Fecal Microbiota
- Being tested
- cranberry, placebo
- Keywords
- cranberry, microbiome, polyphenols, healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cranberryOther
the effect of cranberry on the gut microbiota
placeboOther
the effect of placebo on the gut microbiota
| Study group | Role | What they receive |
|---|---|---|
| cranberry | Active comparator | 30 grams/day freeze dried whole cranberry powder added to a basal diet comprising meats, dairy products, simple sugars, and stevia Receives: Other: cranberry |
| placebo | Placebo comparator | 30 grams/day placebo powder [made with maltodextrin (CPC Maltrin M-180), citric acid, artificial cranberry flavor (Lorann oils), fructose, red color (Lorann oils), and grape shade] added to a basal diet comprising meats, dairy products, simple sugars, and stevia Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
fecal microbiome
16S rRNA in feces will be determined to profile microbiome
Measured: The change in fecal microbiome after consuming the intervention diets for 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fecal MicrobiotaStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Chen, Tufts University
- Investigators
- Oliver Chen, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677649
- Sponsor's protocol ID
- 2870
- Status last verified
- Feb 2017
- First submitted
- 3 Feb 2016
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiota Diversity and Composition and Polyphenol Bioavailability: a Controlled Feeding Trial With a Plant Free Diet Containing Whole Cranberry Powder
- ClinicalTrials.gov ID
- NCT02677649
- Acronym / sponsor ID
- 2870
- Conditions
- Fecal Microbiota
- Keywords
- cranberry, microbiome, polyphenols, healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 9 Feb 2016 (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.
Composition and diversity of intestinal microbiota that are subject to the influence of diet have a significant impact on health in the gut and whole body via complex interactions between food constituents, bacteria, and host. Polyphenols are poorly absorbed in the upper gastrointestinal tract and reach the colon, where they may have a reciprocal relationship with microbiota. Because how polyphenols mediate gut health and reduce risk for other pathogenesis remains to be elucidated, we propose to conduct a pilot controlled feeding study to examine the impact of polyphenols and other constituents in the free dried whole cranberry powder (FWCP) on composition and diversity of gut microbiota, as well as to substantiate bioavailability of cranberry polyphenols. The central hypothesis underlying the proposed research is that FWCP polyphenols will diminish the magnitude of a plant food free diet induced increase in Alistipes, Bilophila and Bacteroides and will increase Enterococcus, Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale groups. The proposed research is novel as no study has examined the specific impact of FWCP polyphenols incorporated into a plant food free diet on gut microbiota. This proposed study is innovative because the positive results will demonstrate with a high degree of confidence that the impact of FWCP constituents on production of beneficial short chain fatty acids, carcinogenic bile acids, and atherogenic trimethylamine. The results generated from the study using a plant food free dietary regimen as the background diet will provide definite proof on microbial modulating actions of FWCP, inform mechanism of actions in urinary tract infection (UTI), and be used to formulate messages in consumer communications for gut health.
Detailed description
Investigators propose conducting a randomized, controlled feeding, crossover trial in 10 adults who have a regular bowel movement (≥5 times/wk) and are willing to consume a diet free of plant foods. The trial will include two 5-d intervention phases with a 2-wk washout period between crossovers. All meals will be provided to subjects during the intervention phases. Subjects will be randomly assigned to receive either Con or FWCP diet containing 30 gram matched placebo or FWCP. The dose is selected in order to provide sufficient amounts of flavonoid and PAC that can be comparable to the average flavonoid and PAC intake at 157 mg and 95 mg/d, respectively in US. The plant food free diet will be formulated to contain only animal based ingredients. All meals will be designed and overseen by Helen Rasmussen, PhD, RD, and be prepared in the kitchen of the Metabolic Research Unit. Packed frozen meals will be provided to subjects to consume at home or work. Coffee, tea, and other plant-based beverages will not be allowed during the intervention phases.
All subjects will be required to provide their informed consent prior to enrolling in the study. Individuals will be screened for study eligibility according to the exclusion criteria, as followed: 1) no antibiotic medications or drugs known to influence fecal microbiota were taken 3 mo before the study; 2) active treatment for doctor diagnosed diseases, such as cancer, cardiovascular diseases, gastrointestinal diseases; 3) regular use of any dietary supplements; 4) colonoscopy 2 mo prior to their enrollment or scheduled during the study; 5) values of standard blood biochemistries are critically abnormal based on study physician's discretion; and 6) use of ≥14/wk serving of alcohol. Subjects who meet all other eligibility criteria and have values of blood biochemistries within normal ranges will be asked to participate in the study.
During the trial, eligible subjects will be required to attend 1 screening visit and 9 study visits over 5-7 wks. At the end of Visits 2 and 6, subjects will receive the randomly assigned frozen meals and begin consuming the study meals for 5 d. Subjects may consume the study meals ≥5 da until the post-intervention stool sample is collected. The whole stool sample will be placed in a sealed bag and then in a cooler with ice packs and transported to the MRU within 24 h. Morning spot urine and 30 mL fasted blood as well as all other clinical data will be collected before and after each intervention phase. All collected samples will be stored at -80 degree C until uses.
The sample size of the human trial was estimated based on the effect of FWCP on the plant food free diet induced increase in bile tolerant bacteria and on the increase in Enterococcus, Bifidobacterium, Eggerthella lenta, and Blautia coccoides-Eubacterium rectale. Since there is no data in the literature illustrating the effect of FWCP on bile tolerant bacteria for power calculation, investigators will employ in the proposed crossover controlled feeding trial 10 subjects to test our hypothesis.
Fecal DNA will be extracted by enzymatic digestion and bead-beating steps followed by the use of QIAamp Stool DNA Mini Kit (Qiagen). 16S rRNA gene amplicons will be generated from the extracted DNA using PCR with a barcoded primer set targeted to the V4 variable region. Amplicons will be sequenced on an Illumina ® MiSeq Sequencer at the Tufts University Core Facility which is directed by Dr. Anne Kane. Microbiota Analysis will be performed using Qiime v 1.7. Operational taxonomic units will be generated using UClust. Alpha and beta diversity parameters will be calculated using Qiime. Urinary flavonoids and phenolic acids will be determined by our routine HPLC-electrochemical detection method. Anthocyanins and their glucuronidate metabolites in urine will be quantified by a LC-MS/MS assay investigators use routinely. Fecal short chain fatty acids will be determined using a GC-MS method that has been established in our laboratory. The pH value in the fecal water of the feces will be determined using a pH meter after centrifugation. Individual bile acids in feces will be determined using a LC-QTOF-MS method. TMA in feces will be determined using a spectrophotometric assay.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cranberry | Active comparator | Other: cranberry30 grams/day freeze dried whole cranberry powder added to a basal diet comprising meats, dairy products, simple sugars, and stevia |
| placebo | Placebo comparator | Other: placebo30 grams/day placebo powder [made with maltodextrin (CPC Maltrin M-180), citric acid, artificial cranberry flavor (Lorann oils), fructose, red color (Lorann oils), and grape shade] added to a basal diet comprising meats, dairy products, simple sugars, and stevia |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 20-55 y
- BMI between 18.5-29.9 kg/m2
- Bowel movement ≥3 times/wk
- Consume ≥3 servings of fruits and vegetables daily on average
- Willing to consume animal based diets for ≥10 days
Key exclusion criteria (22 listed)
- Colonoscopy 2 mo prior to their enrollment or scheduled during the study
- No antibiotic medications or drugs known to influence fecal microbiota were taken or used 3 mo before the study
- History of a bilateral mastectomy
- History of autoimmune disorders (rheumatoid arthritis, lupus, multiple sclerosis, vitiligo, psoriasis)
- Consume <3 servings of fruits and vegetables daily one average
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 |
|---|---|---|
| cranberrythe effect of cranberry on the gut microbiota | Other | cranberry |
| placebothe effect of placebo on the gut microbiota | Other | placebo |
Primary outcome
fecal microbiome
Time frame: The change in fecal microbiome after consuming the intervention diets for 5 days.
16S rRNA in feces will be determined to profile microbiome
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 23 Feb 2017.
- Individual participant dataSharing planned: No
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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.
Oliver Chen, PhD principal investigator
Tufts University
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 in people with Fecal Microbiota, run by Tufts 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 8 inclusion and 22 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 23 Feb 2017. 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 microbiome (time frame: The change in fecal microbiome after consuming the intervention diets for 5 days.). 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 23 Feb 2017.