NCT05184855

Brief Summary

The purpose of this study is to determine if 2-weeks supplementation with blueberries (1 cup/day) compared to placebo can mitigate muscle soreness and damage, and improve inflammation resolution and metabolic recovery during a 5-day period after engaging in an acute, 90-minute bout of eccentric exercise. The primary outcome will be plasma oxylipin levels, extending previously collected data showing that blueberry ingestion decreases post-exercise oxylipins generated from cytochrome P450 enzymes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2022

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

December 22, 2021

Last Update Submit

January 23, 2023

Conditions

Keywords

blueberriesexerciseinflammationoxylipinscytokines

Outcome Measures

Primary Outcomes (1)

  • Plasma concentrations of pro-inflammatory oxylipins: 19-hydroxy-eicosatetraenoic acid (HETE), 20-HETE, 20-cooh-AA, 8,9-dihydroxy-eicosatrienoic (all ng/ml) acid; (diHETrE), 14,15-diHETrE

    Inflammation biomarkers

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

Secondary Outcomes (2)

  • Serum concentration of creatine kinase

    Change from pre-exercise to post-exercise (immediately after, and 1-, 2-, 3-, and 4-days after

  • Urine concentration of hippuric acid

    Change from pre-supplementation to post-2-weeks supplementation of blueberries or placebo

Study Arms (2)

Blueberry

EXPERIMENTAL

26 g freeze-dried blueberry powder per day or approximately one cup fresh blueberries equivalent; two weeks intake.

Dietary Supplement: Blueberry

Placebo

PLACEBO COMPARATOR

26 g placebo powder per day matched for color, taste, aroma; two weeks intake.

Dietary Supplement: Placebo

Interventions

BlueberryDIETARY_SUPPLEMENT

Blueberry powder intake

Blueberry
PlaceboDIETARY_SUPPLEMENT

Placebo powder intake

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female, ages 18-50 years.
  • Non-smoker.
  • Body mass index less than 18.5-30 kg/m2 (not obese).
  • Not engaged in regular resistance training (less than 3 sessions per week).
  • Agree to train normally, maintain weight, and avoid the regular use of protein supplements, 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 study. (Participant will review supplement and medication use with the Research Manager during orientation).
  • Agree to avoid consuming all berries including blueberries, raspberries, and strawberries.
  • Agree to consume no more than an average of five servings per day of vegetables and fruit.
  • 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.
  • Engaged in regular resistance training (3 or more sessions per week, on average).
  • Body weight below 110 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 blueberry ingestion.
  • Postmenopausal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

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

    Appalachian State Univ

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Blueberry powder supplement and a carbohydrate- and fiber-matched placebo powder with flavoring, aroma, and coloring.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, parallel groups
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

January 11, 2022

Study Start

December 1, 2021

Primary Completion

July 30, 2022

Study Completion

August 15, 2022

Last Updated

January 25, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Will provide data upon request.

Locations