Blueberry-protein Supplementation and Exercise

NCT05596500 | Completed

• 1 other identifier: 22-0013
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study is the human clinical trial component of an SBIR grant with Sinnovatek (funded). Cyclists (n=20) will consume a blueberry-protein, blueberry, or placebo supplement for 2 weeks prior to cycling for 2.5 h at high intensity. Washout periods (2 weeks) will separate the 3 trials, and the cyclists will crossover (randomized) to one of the two others supplements for 2 weeks, and then engage in additional 2.5 h cycling bouts. Blood and urine samples will be collected pre- and post-supplementation for each of the 3 trials. Blood samples will also be collected immediately after and 1.5h- and 24h-post-exercise. Blood samples will be analyzed for inflammation and oxidative stress outcomes. Urine samples will be analyzed for blueberry gut-derived phenolics.

Conditions

Inflammatory Response

Keywords

blueberries; exercise; inflammation

Outcome Measures

Primary Outcomes (1)

• Plasma concentrations of inflammasome ASC oligomers

  ASC oligomers are an indicator of inflammasome activation

  Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, and 24 hours-post-exercise

Secondary Outcomes (2)

• Plasma concentrations of 4-hydroxynonenal

  Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, and 24 hours-post-exercise

• Urine concentrations of hippuric acid

  Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, and 24 hours-post-exercise

Study Arms (3)

Blueberry-protein gel

EXPERIMENTAL

Blueberry polyphenols (1 cup fresh blueberries equivalent) from extract with 20 grams rice-pea protein in a gel.

Dietary Supplement: Blueberry-protein gel

Blueberry gel

ACTIVE COMPARATOR

Blueberry polyphenols (1 cup fresh blueberries equivalent) from extract in a gel.

Dietary Supplement: Blueberry gel

Placebo

PLACEBO COMPARATOR

All proximate matched ingredients except for the blueberry polyphenols and plant protein.

Dietary Supplement: Placebo

Interventions

Blueberry-protein gel DIETARY_SUPPLEMENT

Sport gel with blueberry extract and plant protein.

Blueberry-protein gel

Blueberry gel DIETARY_SUPPLEMENT

Sport gel with blueberry extract only.

Blueberry gel

Placebo DIETARY_SUPPLEMENT

Sport gel without the blueberry extract polyphenols and without protein.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female.
• Ages 18-65 years.
• Non-smoker.
• Regularly compete in road races (category 1 to 5) and/or are capable of cycling 2.5 h in a laboratory setting (using their own bicycles on Saris 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 6-week study. (Review supplement and medication use with the Research Manager during orientation).
• 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.

Sponsors & Collaborators

• Appalachian State University: lead
• SinnovaTek: collaborator
• North Carolina State University: collaborator

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; Inflammation

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological 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: Investigators and study participants will be blind to treatment allocation.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized treatment, double blinded procedures, crossover

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: January 15, 2023
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Summer, 2024

Locations

US (1)