Metabolic SyndromeNCT01944579
Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria
A study testing Blackberries in people with Metabolic Syndrome, run by Janet Novotny at 1 site in United States.
Trial summary
Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. Read more about this study
- Who is it for?
- Ages 25 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Blackberries
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Apr 2014
- 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 25 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 25-75 years old
Who cannot join
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
- Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
- Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- Fasting triglycerides greater than 300 mg/dL
- Fasting glucose greater than 126 mg/dL
Show all 15Show fewer
- History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
- Use of prescription or over-the-counter antiobesity medications or supplements (e.g., phenylpropanolamine, ephedrine, caffeine) during and for at least 6 months prior to the start of the study or a history of a surgical intervention for obesity
- Active cardiovascular disease (such as a heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within the last three months, stroke, or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in the past six months).
- Use of any tobacco products in past 3 months
- Unwillingness to abstain from herbal supplements for two weeks prior to the study and during the study
- Known (self-reported) allergy or adverse reaction to blackberries or other study foods
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past twelve months and/or current acute treatment or rehabilitation program for these problems (Long-term participation in Alcoholics Anonymous is not an exclusion)
- Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20906
About this study
Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role.
- Conditions
- Metabolic Syndrome
- Being tested
- Blackberries, Control
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlackberriesOther
Participants will receive blackberries as part of a controlled diet.
ControlOther
Participants will receive a control food (jello) as part of a controlled diet.
| Study group | Role | What they receive |
|---|---|---|
| Control-Blackberry | Experimental | Participants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries. Receives: Other: Blackberries; Other: Control |
| Blackberry-Control | Experimental | Participants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello). Receives: Other: Blackberries; Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fecal microbiota
Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.
Measured: 0 weeks, 4 weeks
Secondary outcomes (1)
Change in blackberry nutrients & metabolites
Measured: 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janet Novotny
- Sponsor type
- US federal agency
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
- Investigators
- Janet A Novotny, Ph.D., Principal investigator, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944579
- Sponsor's protocol ID
- HS40
- Status last verified
- Jul 2014
- First submitted
- 12 Sep 2013
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria
- ClinicalTrials.gov ID
- NCT01944579
- Acronym / sponsor ID
- HS40
- Conditions
- Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Janet NovotnyUS federal agency
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 17 Sep 2013 (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.
Intestinal bacteria can metabolize unabsorbed polyphenols (plant compounds) to produce smaller molecules which may impact health. In addition, evidence suggests that this process may be affected by body fatness. This study aims to investigate absorption of blackberry polyphenols, their impact on intestinal bacteria, polyphenol metabolites formed by intestinal bacteria, and how these processes differ for obese and lean individuals. It is hypothesized that polyphenol absorption and metabolism will differ between obese and lean individuals and that differences in intestinal microbiota may play a role.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control-Blackberry | Experimental | Other: Blackberries, Other: ControlParticipants will receive a controlled diet with the control food (jello) first and then cross over to the controlled diet with blackberries. |
| Blackberry-Control | Experimental | Other: Blackberries, Other: ControlParticipants will receive a controlled diet with blackberries first and then cross over to the controlled diet with the control food (jello). |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 25-75 years old
Key exclusion criteria (15 listed)
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol (dicumarol), or Miradon (anisindione)
- Presence of any gastrointestinal disease, metabolic disease, or malabsorption syndromes that may interfere with the study goals
- Have been pregnant during the previous 12 months, are currently pregnant or lactating, or plan to become pregnant during the study
- Type 2 diabetes requiring the use of oral antidiabetic agents or insulin
- Fasting triglycerides greater than 300 mg/dL
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 |
|---|---|---|
| BlackberriesParticipants will receive blackberries as part of a controlled diet. | Other | Blackberry-Control, Control-Blackberry |
| ControlParticipants will receive a control food (jello) as part of a controlled diet. | Other | Blackberry-Control, Control-Blackberry |
Primary outcome
Change in fecal microbiota
Time frame: 0 weeks, 4 weeks
Feces will be analyzed for bacterial typing at 0 and 4 weeks of each diet period.
1 secondary outcome
Change in blackberry nutrients & metabolites
Time frame: 0, 30, 60, 90, 120, 150, 180, 240, 300, 360, and 420 minutes
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 22 Jul 2014.
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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.
Janet A Novotny, Ph.D. principal investigator
USDA Beltsville Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blackberries in people with Metabolic Syndrome, run by Janet Novotny 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 15 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 22 Jul 2014. 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 fecal microbiota (time frame: 0 weeks, 4 weeks). 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 22 Jul 2014.