ObesityNCT03934177
Impact of Blueberry Consumption on Gastrointestinal Health
A study testing Blueberry powder in people with Obesity and Circadian Dysregulation, run by University of Nebraska Lincoln at 2 sites in United States.
Trial summary
This study will evaluate the impact of blueberry consumption on markers of gastrointestinal health including gut microbiota, intestinal permeability, and gut-derived inflammation in those vulnerable to a unhealthy gut milieu. All participants will consume a blueberry powder and a placebo in this crossover study. Read more about this study
- Who is it for?
- Ages 19 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Circadian Dysregulation
- What is being tested?
- Blueberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2019to 2 Mar 2023
- 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 19 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- obese (BMI +/- 30.0 kg/m2)
- shift workers (shift work overnight (third shift) +/= 3 days/week for the past 3 months)
- 19-70 years of age
Who cannot join
- patient history of gastrointestinal diseases except for hiatal hernia, GERD, or hemorrhoids, mild gastrointestinal symptoms
- elevated laboratory values from a comprehensive metabolic panel (CMP) and complete blood count (CBC) with the exception of glucose (+/= 126 mg/dL; if elevated, confirmed with HA1c of greater than or equal to 6.5%) and ALT, AST, or ALP over 2 times normal levels (to allow for mild elevations resulting from fatty liver often seen in obese) unless approved by study physician
- currently pregnant or plans to become pregnant during the study as determined by participant report
- antibiotic use within the last 12 weeks prior to enrollment
- presence of chronic metabolic disease (e.g., cardiovascular disease, diabetes, cancer) or per physician discretion
- recent (past 4 weeks) major change in dietary habits or a plan to have a major change in dietary habits during the study
Show all 11Show fewer
- habitual blueberry consumption of more than 0.5 cups 2x/week or a 4-week washout period if consumes
- allergy or intolerance to blueberries
- consumption of supplemental fiber, probiotics or prebiotics without an appropriate 4-week washout period
- restrictive dietary patterns (e.g., ketogenic, Paleolithic) or a diet high in fiber (+/= 14 g/1000 kilocalories) to increase study result generalizability to the U.S. population (low-fiber diet), as well as provide another stimuli for gut leakiness
- unwillingness to consent to the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Nebraska
Lincoln, Nebraska, 68132
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Official title: Impact of Blueberry Consumption on Intestinal Permeability, Gut Microbiota, and Gut-Derived Inflammation in Individuals With Elevated Risk of a Pro-Inflammatory Gut Milieu
This study will evaluate the impact of blueberry consumption on markers of gastrointestinal health including gut microbiota, intestinal permeability, and gut-derived inflammation in those vulnerable to a unhealthy gut milieu. All participants will consume a blueberry powder and a placebo in this crossover study.
Read the detailed description
The commensal bacteria that reside in the human gut, known as the gut microbiota, is a complex system that modulates local gut homeostasis and systemic biological processes. Several environmental factors have been shown to influence the gut milieu (including microbiota), and thus both gastrointestinal and host health. Relevant to the current proposal is the influence of body weight, diet, and circadian rhythms. In the current study, the investigators propose to use these common disruptors of gastrointestinal health through recruiting obese shift workers with a low-fiber diet to identify if these disrupted individuals can benefit from blueberry intake. Specifically, the study objectives are to determine if 24 g whole blueberry powder consumed daily can beneficially modify intestinal permeability, gut microbiota, microbial metabolites, and both gut-derived and systemic inflammation in those most susceptible to a pro-inflammatory milieu. This will be accomplished through a 14-week crossover study in which 28 individuals will be randomized by treatment group order to 4 weeks of whole blueberry powder and placebo powder, with a 4-week wash out in between the treatment periods.
- Conditions
- Obesity, Circadian Dysregulation
- Being tested
- Blueberry powder, Placebo powder
- Keywords
- Blueberry, Microbiota, Intestinal permeability
- Medical subject headings
- Obesity, Chronobiology Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry powderDietary supplement
Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart.
Placebo powderDietary supplement
A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry powder | Experimental | 4 weeks of supplementation of 24 g whole blueberry powder Receives: Dietary Supplement: Blueberry powder |
| Placebo powder | Placebo comparator | 4 weeks of supplementation of 24 g placebo powder (maltodextrin) Receives: Dietary Supplement: Placebo powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
intestinal permeability
urinary sugar measurement by gas chromatography (GC): Sucralose, lactulose, mannitol, sucrose as a percent of oral dose.
Measured: 28 days
Secondary outcomes (3)
Microbiota
Microbiota composition through shotgun sequencing. Composition includes relative abundance of all microbes in stool.
Measured: 28 days
Microbial metabolites
Quantity of stool short-chain fatty acid (butyrate, propionate, acetate) per dry stool weight by gas chromatography
Measured: 28 days
Gut-derived/systemic inflammation
Concentration of serum lipopolysaccharide (LPS), LPS-binding protein (LBP), and interleukin-6 (IL6)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start26 Mar 2019
- Primary completion2 Mar 2023
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This 14-week crossover study includes 4 weeks for each of the two supplementation periods (blueberries and placebo), with a 4-week wash out between.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- Rush University Medical Center, University of Nebraska
- Responsible party
- Sponsor
- Investigators
- Heather E Rasmussen, PhD, Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934177
- Sponsor's protocol ID
- 18557
- Status last verified
- Mar 2023
- First submitted
- 15 Apr 2019
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blueberry Consumption on Intestinal Permeability, Gut Microbiota, and Gut-Derived Inflammation in Individuals With Elevated Risk of a Pro-Inflammatory Gut Milieu
- ClinicalTrials.gov ID
- NCT03934177
- Acronym / sponsor ID
- 18557
- Conditions
- Obesity, Circadian Dysregulation
- Keywords
- Blueberry, Microbiota, Intestinal permeability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- Rush University Medical Center, University of Nebraska
- Study start
- 26 Mar 2019 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 1 May 2019 (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 study will evaluate the impact of blueberry consumption on markers of gastrointestinal health including gut microbiota, intestinal permeability, and gut-derived inflammation in those vulnerable to a unhealthy gut milieu. All participants will consume a blueberry powder and a placebo in this crossover study.
Detailed description
The commensal bacteria that reside in the human gut, known as the gut microbiota, is a complex system that modulates local gut homeostasis and systemic biological processes. Several environmental factors have been shown to influence the gut milieu (including microbiota), and thus both gastrointestinal and host health. Relevant to the current proposal is the influence of body weight, diet, and circadian rhythms. In the current study, the investigators propose to use these common disruptors of gastrointestinal health through recruiting obese shift workers with a low-fiber diet to identify if these disrupted individuals can benefit from blueberry intake. Specifically, the study objectives are to determine if 24 g whole blueberry powder consumed daily can beneficially modify intestinal permeability, gut microbiota, microbial metabolites, and both gut-derived and systemic inflammation in those most susceptible to a pro-inflammatory milieu. This will be accomplished through a 14-week crossover study in which 28 individuals will be randomized by treatment group order to 4 weeks of whole blueberry powder and placebo powder, with a 4-week wash out in between the treatment periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This 14-week crossover study includes 4 weeks for each of the two supplementation periods (blueberries and placebo), with a 4-week wash out between.
| Arm | Type | Receives |
|---|---|---|
| Blueberry powder | Experimental | Dietary Supplement: Blueberry powder4 weeks of supplementation of 24 g whole blueberry powder |
| Placebo powder | Placebo comparator | Dietary Supplement: Placebo powder4 weeks of supplementation of 24 g placebo powder (maltodextrin) |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- obese (BMI +/- 30.0 kg/m2)
- shift workers (shift work overnight (third shift) +/= 3 days/week for the past 3 months)
- 19-70 years of age
Key exclusion criteria (11 listed)
- patient history of gastrointestinal diseases except for hiatal hernia, GERD, or hemorrhoids, mild gastrointestinal symptoms
- elevated laboratory values from a comprehensive metabolic panel (CMP) and complete blood count (CBC) with the exception of glucose (+/= 126 mg/dL; if elevated, confirmed with HA1c of greater than or equal to 6.5%) and ALT, AST, or ALP over 2 times normal levels (to allow for mild elevations resulting from fatty liver often seen in obese) unless approved by study physician
- currently pregnant or plans to become pregnant during the study as determined by participant report
- antibiotic use within the last 12 weeks prior to enrollment
- presence of chronic metabolic disease (e.g., cardiovascular disease, diabetes, cancer) or per physician discretion
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 |
|---|---|---|
| Blueberry powderDried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart. | Dietary supplement | Blueberry powder |
| Placebo powderA placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart. | Dietary supplement | Placebo powder |
Primary outcome
intestinal permeability
Time frame: 28 days
urinary sugar measurement by gas chromatography (GC): Sucralose, lactulose, mannitol, sucrose as a percent of oral dose.
3 secondary outcomes
Microbiota
Time frame: 28 days
Microbial metabolites
Time frame: 28 days
Gut-derived/systemic inflammation
Time frame: 28 days
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 Mar 2023.
- 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.
Heather E Rasmussen, PhD principal investigator
University of Nebraska Lincoln
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry powder in people with Obesity and Circadian Dysregulation, run by University of Nebraska Lincoln at 2 sites 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 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 22 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 2 sites 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?
intestinal permeability (time frame: 28 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 22 Mar 2023.