NCT05407701

Brief Summary

This is a randomized, crossover clinical trial with 25 male and female cyclists. Study participants will ingest polyphenol-rich cranberry juice or placebo juice for 4 weeks under double-blinded procedures, and then crossover to the opposite supplement. The primary objective of this study is to examine the efficacy of 4-weeks ingestion of cranberry juice in moderating exercise-induced inflammation, immune dysfunction, and muscle damage. Outcome measures will include global proteiomics, oxylipins, and cytokines.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

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

Study Start

First participant enrolled

June 1, 2022

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

June 2, 2022

Last Update Submit

January 24, 2023

Conditions

Inflammatory ResponseMetabolic DisturbanceImmune Suppression

Keywords

Cranberriesexerciseimmune functionoxylipinsproteomics

Outcome Measures

Primary Outcomes (1)

  • Blood lymphocyte proliferation

    The mitogenic response of lymphocytes will be determined in whole blood culture using suboptimal mitogen (Concanavalin A) doses

    Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

Secondary Outcomes (3)

  • Plasma lipid mediators

    Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

  • Plasma proteins

    Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

  • Plasma cytokine panel

    Change from pre-study to post-4 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

Study Arms (2)

Cranberry

EXPERIMENTAL

100% juice active: water, cranberry juice concentrate.

Dietary Supplement: Cranberry Juice

Placebo

PLACEBO COMPARATOR

100% juice placebo: water, fructose, dextrose, citric acid, malic acid, natural flavors, pectin, cherry colorant, sucralose.

Dietary Supplement: Placebo

Interventions

Cranberry JuiceDIETARY_SUPPLEMENT

100% cranberry juice

Cranberry
PlaceboDIETARY_SUPPLEMENT

Placebo juice

Placebo

Eligibility Criteria

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

You may qualify if:

  • Male or female cyclist, ages 18-55 years, and capable of cycling 2.25 h in the lab on trainers at 70% VO2max (close to race pace).
  • Non-smoker
  • Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.
  • Categorized as "low risk" using the American College of Sports Medicine screening questionnaire.
  • Agree to train normally, maintain weight, and avoid the regular use of large-dose vitamin and mineral supplements, herbs, and medications that influence inflammation (especially NSAIDs) for the duration of the 10-week study.
  • Agree to taper their exercise routine prior to each of the two lab cycling sessions.
  • Agree to avoid ingestion of cranberry products during the study (other than provided).

You may not qualify if:

  • Inability to comply with study requirements.
  • History of allergic reactions to cranberry ingestion.
  • Females: body weight below 110 pounds; pregnant or breastfeeding.
  • Any other concurrent condition which, in the opinion of the principle 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).

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 Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Investigators and study participants will be blind to treatment allocation, with the cranberry and placebo beverages of the same taste and color, and contained in identical looking bottles.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized treatment, double blinded procedures, crossover
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2022

First Posted

June 7, 2022

Study Start

June 1, 2022

Primary Completion

November 15, 2022

Study Completion

January 15, 2023

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

Will share data upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
December, 2022, indefinitely
Access Criteria
Upon request

Locations

US(1)