NCT03934177

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 26, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

3.9 years

First QC Date

April 15, 2019

Last Update Submit

March 20, 2023

Conditions

ObesityCircadian Dysregulation

Keywords

BlueberryMicrobiotaIntestinal permeability

Outcome Measures

Primary Outcomes (1)

  • intestinal permeability

    urinary sugar measurement by gas chromatography (GC): Sucralose, lactulose, mannitol, sucrose as a percent of oral dose.

    28 days

Secondary Outcomes (3)

  • Microbiota

    28 days

  • Microbial metabolites

    28 days

  • Gut-derived/systemic inflammation

    28 days

Study Arms (2)

Blueberry powder

EXPERIMENTAL

4 weeks of supplementation of 24 g whole blueberry powder

Dietary Supplement: Blueberry powder

Placebo powder

PLACEBO COMPARATOR

4 weeks of supplementation of 24 g placebo powder (maltodextrin)

Dietary Supplement: Placebo powder

Interventions

Blueberry powderDIETARY_SUPPLEMENT

Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart.

Blueberry powder
Placebo powderDIETARY_SUPPLEMENT

A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart.

Placebo powder

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • obese (BMI +/- 30.0 kg/m2)
  • shift workers (shift work overnight (third shift) +/= 3 days/week for the past 3 months)
  • years of age

You may not qualify if:

  • 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
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Nebraska

Lincoln, Nebraska, 68132, United States

Location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location

MeSH Terms

Conditions

ObesityChronobiology Disorders

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsNervous System Diseases

Study Officials

  • Heather E Rasmussen, PhD

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Participants, investigators, and statistician will blinded to treatment.
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2019

First Posted

May 1, 2019

Study Start

March 26, 2019

Primary Completion

March 2, 2023

Study Completion

March 2, 2023

Last Updated

March 22, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

US(2)