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CompletedNCT03445234Updated Feb 26, 2018

Blueberries, Bananas, Exercise Recovery

An interventional study of Blueberry and Placebo in Inflammatory Response, Metabolic Disturbance and Immune Suppression, sponsored by Appalachian State University. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-02-26.

Sponsored by Appalachian State University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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. Enhance performance.
  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. 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. 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).
Read the detailed description

LAB VISIT #1: ORIENTATION AND BASELINE TESTING (about 1.5 hours):

One to two weeks prior to the start of the study, study participants will report to the NCRC Human Performance Lab for orientation and baseline testing. Study participants will be screened to verify "low risk" status for cardiovascular disease, and provide voluntary consent. Demographic and training histories will be acquired with questionnaires. Study participants will be tested for VO2max (i.e., maximal oxygen consumption) using the Lodi cycle ergometer. Percent body fat will be measured using the BodPod. Study participants will sit inside the BodPod with a tight-fitting swim suit for about 10 minutes while body fat is calculated.

LAB VISIT #2: START OF 2-WEEK SUPPLEMENTATION PERIOD (about 20 minutes)

On the assigned date and time, study participants will return to the lab in an overnight fasted state (9 or more hours with no food or beverage including coffee and tea, other than water). A blood sample will be collected from an arm or hand vein by trained phlebotomists. Each blood sample will not exceed 35 ml (2.3 tablespoons), and will be analyzed for indicators of immune function, inflammation, muscle damage, stress hormones, and indicators of plant polyphenol metabolism.

Study participants will be randomized to blueberry and placebo groups, and be given a 14-day supply of freeze-dried blueberry powder or placebo powder. The blueberry and placebo supplements will be ingested daily for 2-weeks prior to participation in the 75-km cycling time trial, the day of the exercise trial (after the blood draw, and supplied at the lab), and one day of recovery (after the blood draw, and supplied at the lab (thus 16 days total). The blueberry powder supplement (26 g per day or approximately one cup fresh blueberries equivalent) will consist of freeze-dried wild blueberries prepared by Future Ceuticals (Momence, IL). This product contains all of the polyphenols (in particular, anthocyanins), fiber, and natural sugars contained in fresh wild blueberries. The placebo powder will look identical but not contain freeze-dried blueberries. The placebo blueberry powder will consist of blueberry flavoring (2.8%), coloring (0.7% artificial purple, 0.3% artificial red), maltodextrin (21%), fructose (3.5%), citric acid (0.7%), and a silica flow agent (0.5%). Study participants will consume the blueberry and placebo powders by mixing them in fruit juices, yogurts, milk, or other products during the first meal of each day for two weeks. The blueberry and placebo powders should be stored in the freezer section of the refrigerator in the containers supplied to study participants.

LAB VISIT #3: POST-SUPPLEMENTATION LAB VISIT WITH 75-km CYCLING (about 8-9 hours)

  • During the 3-day period prior to the 75-km cycling trial, study participants will taper exercise training and ingest a moderate-carbohydrate diet, with foods chosen from a food list moderating use of high fat foods, visible fats, and fruit/vegetable polyphenols. Study participants will record all food and beverage intake during the 3-day period.
  • After the 2-week supplementation period, study participants will return to the lab at 7:00 am in an overnight fasted and rested state (on the same day of the week and time as the pre-supplementation lab visit).

    • Study participants will turn in the 3-day food record.
    • Study participants will verify that they have ingested the assigned supplement each day.
    • A 35 ml blood sample will be collected.
    • Study participants will next ingest 26 g of freeze-dried blueberry powder or placebo powder in 1.5 cups of water (with Equal packets available to improve taste as desired).
    • A simple questionnaire will be used for study participants to indicate muscle soreness (DOMS).
    • Study participants will complete a symptom log, which will include questions on digestive and mental health (heartburn, bloating, diarrhea, nausea, energy levels, ability to focus, etc.). Study participants will indicate responses using a 12-point Likert scale, with 1 relating to "none at all", 6 "moderate", and 12 "very high".
    • Study participants will be randomized to cycle 75-km on water alone or with bananas and water (and this will be revealed after the blood draw). Twenty minutes after ingesting the supplement, study participants will start the 75-km cycling time trial.

      75-km CYCLING TIME TRIAL

7:30 am: Start 75-km cycling time trial. Study participants are to complete the 75-km course as fast as possible.

  • Study participants will use their own bicycles on CompuTrainer Pro Model 8001 trainers (RacerMate, Seattle, WA). A mountainous 75-km course with moderate difficulty will be utilized using the CompuTrainer software system.
  • Heart rate and rating of perceived exertion (RPE) will be recorded every 30 minutes, and workload (watts) continuously monitored using the CompuTrainer MultiRider software system (version 3.0, RacerMate, Seattle, WA).
  • Oxygen consumption, carbon dioxide production, and ventilation will be measured using the Cosmed metabolic cart after 16 km and 55 km cycling (through a facemask similar to what occurred during baseline testing). Performance will be monitored throughout the 75-km cycling time trial using percentage of maximal watts to ensure that a full effort is being given.
  • Study participants will consume 3 ml/kg water every 15 min (e.g., about one cup for a 75 kg cyclist).
  • If randomized to ingest bananas with water: Study participants will ingest Cavendish bananas, with the volume adjusted to 0.2 g carbohydrate/kg body weight every 15 minutes (or 0.8 g/kg carbohydrate per hour) during the 75-km time trials. For a 75-kg cyclist, fruit intake will be approximately one-half banana every 15 minutes. Bananas will be provided by Dole Foods at the appropriate ripening stage (full yellow, stage six). No other beverage or food containing energy or nutrients will be allowed during the cycling time trials.

    \~10:00-11:30 am: Immediate-post-exercise, 1.5-h recovery blood samples; lunch

  • Blood samples will be taken from the arm vein immediately after completing the 75-km time trial, and then at 1.5-h post-exercise.
  • Immediately post-exercise, study participants will complete the symptom log.
  • Study participants will indicate muscle soreness using the DOMS questionnaire immediately post-exercise and 1.5-h post-exercise.
  • Study participants will ingest no food or beverage other than water (7 ml/kg or about two cups during the 1.5 h post-exercise period).
  • Right after the 1.5-h recovery blood sample has been collected, study participants will ingest a meal adjusted to 12 kcal/kg body weight. The meal will be prepared by Dole Foods and include grilled chicken, rice, corn, green beans, salt, and water.

    \~11:30 am to 3:00 pm: 3-h and 5-h recovery

  • Additional blood samples and DOMS responses will be collected 3-h and 5-h post-exercise. During this time, study participants will rest quietly in the lab.

LAB VISITS #4 and #5: RECOVERY DAY BLOOD SAMPLES, 7:00 am:

  • Study participants will return to the lab the following two mornings in an overnight fasted state at about 7:00 am (\~21-h and 45-h after completing the 75-km time trial). Blood samples and responses to the DOMS questionnaire will be collected at both lab visits. Study participants will ingest the blueberry or placebo powder in the lab on the first recovery day following the blood sample collection.
02

Conditions studied

  • Inflammatory Response
  • Metabolic Disturbance
  • Immune Suppression

Keywords

  • exercise
  • innate immune function
  • metabolomics
  • inflammation
03

In context

Motor Activity

9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.

This study's enrollment of 60 is close to the median of 60 across 8,388 interventional studies indexed under Motor Activity.

Browse Motor Activity studies →

Lead sponsor

Appalachian State University is the lead sponsor of 41 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    Blueberry

    Freeze-dried blueberry powder

    Dietary Supplement: Blueberry

  • Placebo comparator
    Placebo

    Placebo powder

    Dietary Supplement: Placebo

  • Experimental
    Banana

    Acute banana ingestion

    Dietary Supplement: banana

  • Experimental
    No banana

    No banana ingestion

    Dietary Supplement: No banana

Interventions

  • Dietary supplementBlueberry

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

    Also known as: Placebo

  • Dietary supplementPlacebo

    Placebo powder

  • Dietary supplementbanana

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

  • Dietary supplementNo banana

    water only

06

What researchers measure

Primary outcomes

  1. Inflammation

    Cytokines

    Time frame: 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

  1. Metabolite shifts

    Targeted panel of metabolites

    Time frame: 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)

  2. Natural killer cell activity

    Innate immune function

    Time frame: 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)

  3. Exercise performance

    75-km cycling time trial, with or without bananas

    Time frame: After the 2-week period of blueberry or placebo intake

  4. Targeted proteomics

    Targeted panel of 24 immune proteins including S100A8 and S100A12

    Time frame: 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)

  5. Muscle damage

    Creatine kinase

    Time frame: 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)

  6. Lipid mediators

    Arachadonic acid oxidized derivatives from LC-MS-MS analysis

    Time frame: 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)

07

Study locations

1 site
  • North Carolina Research Campus, Human Performance Lab
    Kannapolis, North Carolina 28081, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03445234
Lead sponsor
Appalachian State University
Collaborators
Dole Food Company
Responsible party
Sponsor
First posted
Feb 26, 2018
Start date
Sep 11, 2017
Primary completion
Dec 15, 2017
Completion
Dec 15, 2017
Last update
Feb 26, 2018

Study contacts

David C. Nieman, DrPH
principal investigator · Appalachian State Univ

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Blueberry extract · Banana

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