NCT03445234

Brief Summary

The PURPOSE of this study is to investigate the combined influence of 2-weeks blueberry ingestion and banana ingestion (during exercise) on performance and in mitigating metabolic perturbation, immune dysfunction, and increase in inflammation following a 75-km cycling time trial. We hypothesize that the combination of 2-weeks ingestion of blueberries (versus placebo) and acute ingestion of bananas (versus water alone) during 75-km cycling will:

  1. 1.Enhance performance.
  2. 2.Attenuate the magnitude of metabolic perturbation due to exercise (using a targeted panel of metabolites) which may be associated with increased plasma levels of beneficial gut-derived phenolics.
  3. 3.Attenuate post-exercise inflammation (as measured with cytokines, muscle damage markers, regulatory lipid mediators, ex-vivo monocyte cell cultures, and targeted immune proteins including S100A8 and S100A12).
  4. 4.Counter post-exercise downturns in innate immune function (natural killer cell lytic activity), and viral defense (using an ex-vivo cell culture with Hela cells).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 10, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

September 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 26, 2018

Completed
Last Updated

February 26, 2018

Status Verified

January 1, 2018

Enrollment Period

3 months

First QC Date

August 10, 2017

Last Update Submit

February 22, 2018

Conditions

Keywords

exerciseinnate immune functionmetabolomicsinflammation

Outcome Measures

Primary Outcomes (1)

  • Inflammation

    Cytokines

    Change from pre-supplementation to post-2-weeks supplementation, and to six post-exercise time points (0, 1.5, 3.0, 5.0, 21, 45 hours)

Secondary Outcomes (6)

  • Metabolite shifts

    Change from pre-supplementation to post-2-weeks supplementation, and to six post-exercise time points (0, 1.5, 3.0, 5.0, 21, 45 hours)

  • Natural killer cell activity

    Change from pre-supplementation to post-2-weeks supplementation, and to six post-exercise time points (0, 1.5, 3.0, 5.0, 21, 45 hours)

  • Exercise performance

    After the 2-week period of blueberry or placebo intake

  • Targeted proteomics

    Change from pre-supplementation to post-2-weeks supplementation, and to six post-exercise time points (0, 1.5, 3.0, 5.0, 21, 45 hours)

  • Muscle damage

    Change from pre-supplementation to post-2-weeks supplementation, and to six post-exercise time points (0, 1.5, 3.0, 5.0, 21, 45 hours)

  • +1 more secondary outcomes

Study Arms (4)

Blueberry

EXPERIMENTAL

Freeze-dried blueberry powder

Dietary Supplement: Blueberry

Placebo

PLACEBO COMPARATOR

Placebo powder

Dietary Supplement: Placebo

Banana

EXPERIMENTAL

Acute banana ingestion

Dietary Supplement: banana

No banana

EXPERIMENTAL

No banana ingestion

Dietary Supplement: No banana

Interventions

BlueberryDIETARY_SUPPLEMENT

26 g/day freeze-dried powder, 2 weeks duration

Also known as: Placebo
Blueberry
PlaceboDIETARY_SUPPLEMENT

Placebo powder

Placebo
bananaDIETARY_SUPPLEMENT

Acute ingestion of bananas 0.2 g carb/kg every 15 min exercise with water

Banana
No bananaDIETARY_SUPPLEMENT

water only

No banana

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female.
  • Ages 18-55 years.
  • Non-smoker.
  • Regularly compete in road races (category 1 to 5) and/or are capable of cycling 75 km in a laboratory setting (using own bicycles on CompuTrainer training systems).
  • Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation and immune function (especially Advil, Motrin, aspirin, and similar anti-inflammatory drugs) for the duration of the 2.5-week study. If in doubt, please discuss your supplement and medication use with the Research Manager during orientation (Courtney Goodman).
  • Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
  • Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.

You may not qualify if:

  • Inability to comply with study requirements.
  • Body weight below 100 pounds.
  • Pregnant or breastfeeding.
  • Any other concurrent condition which, in the opinion of the primary investigator (PI), would preclude participation in this study or interfere with compliance.
  • Current diagnosis of cardiovascular disease, diabetes, or cancer (except for non-melanoma skin cancer).
  • History of allergic reactions to blueberries or bananas.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Carolina Research Campus, Human Performance Lab

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Motor ActivityInflammation

Interventions

blueberry extract

Condition Hierarchy (Ancestors)

BehaviorPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David C. Nieman, DrPH

    Appalachian State Univ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Blueberry freeze dried powder or placebo powder
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized parallel group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2017

First Posted

February 26, 2018

Study Start

September 11, 2017

Primary Completion

December 15, 2017

Study Completion

December 15, 2017

Last Updated

February 26, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations