Beet Supplementation, Exercise, Inflammation

NCT05907135 | Completed

• 1 other identifier: HS-23-297
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine if ingesting a beet-based supplement with nitrates for 2 weeks moderates exercise-induced inflammation.

Conditions

Inflammatory Response; Metabolic Disturbance; Immune Suppression

Keywords

Beets; exercise; inflammation; immune function; oxylipins; proteomics

Outcome Measures

Primary Outcomes (1)

• Plasma lipid mediators

  Plasma concentrations of arachidonic acid oxidized derivatives from LC-MS/MS analysis

  Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

Secondary Outcomes (2)

• Plasma proteins

  Change from pre-study to post-2 weeks supplementation, and immediately post-exercise, and 1.5 hours-, 3 hours-, and 24 hours-post-exercise

• Plasma nitrate and nitrite concentrations

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

Study Arms (2)

Beet

EXPERIMENTAL

Powdered beets with green tea extract, Camu Camu, Quinoa sprouts, 3 mushroom blend.

Dietary Supplement: Beet

Placebo

PLACEBO COMPARATOR

Similar colored powder with no active ingredients.

Dietary Supplement: Placebo

Interventions

Beet DIETARY_SUPPLEMENT

Beet-based powder with other ingredients

Beet

Placebo DIETARY_SUPPLEMENT

Placebo powder.

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female cyclists, ages 18-60 years, and capable of cycling 2.25 h in the laboratory at 70% VO2max (close to race pace).
• Non-smoker, and 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 6-week study and at least a 2-week period prior to the study.
• Agree to limit intake of nitrate-rich vegetables during the study to less than 1 cup per day. These include spinach, lettuce, beets, beetroot juice, celery, and cabbage.
• Agree to taper their exercise routine prior to each of the two lab cycling sessions.
• Agree to avoid the use of mouthwashes, antacids, and chewing gum during the entire 6-week study and the 2-week period prior to the study.

You may not qualify if:

• Inability to comply with study requirements.
• Females: body weight below 110 pounds; trying to become pregnant, pregnant or breastfeeding.
• Any other concurrent condition which, in the opinion of the principal 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).
• An unwillingness to avoid mouthwashes, antacids, and chewing gum 2 weeks before and during the 6-week study.
• An unwillingness to limit intake of nitrate-rich vegetables 2 weeks before and during the 6-week study.
• Current history of uncontrolled hypertension and/or the use of vasodilatory medications.
• Sensitivity to caffeine intake from green tea extract (200 mg per day).
• History of allergic reactions to any of the ingredients in the study supplement: beet powder, camu camu, green tea extract, mushroom blend (caterpillar fungus, lion's mane, chaga), quinoa sprouts, monk fruit, pineapple, cranberry seed powder, strawberry fruit powder).

Sponsors & Collaborators

• Appalachian State University: lead
• Standard Process: 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

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

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, with the beet-based supplement and placebo supplement of the same color and taste.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized treatment, double blinded procedures, crossover

Study Record Dates

• First Submitted: June 8, 2023
• First Posted: June 18, 2023
• Study Start: July 15, 2023
• Primary Completion: November 11, 2023
• Study Completion: December 9, 2023
• Last Updated: December 20, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 2023, indefinitely
• Access Criteria: Upon reasonable request.

Locations

US (1)