Mangoes and Exercise Inflammation

NCT05409105 | Completed

• 1 other identifier: 22-0127
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Vigorous exercise bouts result in significant inflammation and muscle soreness. Our research group has published several papers showing that ingestion of various types of fruits enhances inflammation resolution after exercise. Mangoes have a unique nutrient profile (carotenoids, polyphenols, sugars, vitamins) that we hypothesize will mitigate post-exercise inflammation and muscle soreness. This study will examine the effect of 2 cups/day frozen mango ingestion (2 weeks, 330 g/day) in moderating exercise-induced (2.25 h cycling) inflammation and muscle soreness in a randomized crossover trial. Participants will include 20 male and female young adult cyclists (ages 18-60 years) who are capable of cycling 2.25 h in the laboratory on trainers. In random order, the cyclists will supplement their diets with 2 cups/day mangoes with 1 cup water or 1 cup water alone for two weeks, followed by the 2.25-h exercise challenge. Blood and urine samples will be collected pre- and post-2 weeks supplementation. Additional blood samples will be collected immediately post-exercise, and then 1.5-h, 3-h, and 24-h post-exercise. Urine samples will be analyzed for mango-related metabolites to confirm compliance to the supplementation regimen and to establish statistical relationships with inflammation-related outcomes. The blood samples will be analyzed for novel, cutting-edge outcomes related to inflammation including 70 oxylipins, inflammasome activation, and pro-inflammatory cytokines that we have previously shown are sensitive to exercise and nutrition-based interventions. If the data support our hypothesis, mango ingestion will be viewed as a nutritional strategy to counter exercise-induced inflammation by fitness enthusiasts and athletes who exercise vigorously on a regular basis.

Conditions

Inflammatory Response; Muscular Injury

Keywords

mangoes; exercise; inflammation; oxylipins; inflammasome

Outcome Measures

Primary Outcomes (1)

• Plasma lipid mediators

  Plasma concentrations of arachadonic 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)

• Urine mango metabolites

  Change from pre-study to post-2 weeks supplementation

• Plasma inflammasome activation

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

Study Arms (2)

Mangoes

EXPERIMENTAL

Frozen mangoes, 2 cups per day (with 2 cups water), 2 weeks.

Dietary Supplement: Mangoes

Water

ACTIVE COMPARATOR

Bottled water, 2 cups per day

Dietary Supplement: Water

Interventions

Mangoes DIETARY_SUPPLEMENT

Frozen mangoes, 2 cups per day, 2 weeks

Mangoes

Water DIETARY_SUPPLEMENT

2 cups/day bottled water, 2 weeks

Water

Eligibility Criteria

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

You may qualify if:

• Male or female cyclist, ages 18-60 years, and capable of cycling 2.25 h in the lab on trainers 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 taper their exercise routine prior to each of the two lab cycling sessions.
• Agree to avoid ingestion of mangoes (fresh or within other products) during the study (other than provided).

You may not qualify if:

• Inability to comply with study requirements, history of allergic reactions to mangoes.
• 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).

Sponsors & Collaborators

• Appalachian State University: lead

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

Water

Condition Hierarchy (Ancestors)

Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• David C Nieman, DrPH

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized treatment, crossover

Study Record Dates

• First Submitted: May 12, 2022
• First Posted: June 8, 2022
• Study Start: August 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: January 30, 2023
• Last Updated: June 12, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: December 2022, indefinitely
• Access Criteria: Upon request.

Locations

US (1)