Flavonoids, Exercise, Gut-Derived Phenolics

NCT03249571 | Completed

• 1 other identifier: 17-0240
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

PURPOSE:

1. 1.PRIMARY: Using a randomized, parallel group design, this investigation will determine if the combination of 2-weeks polyphenol supplementation (using the Reoxcyn flavonoid supplement in capsule form) and one acute 45-minute brisk walking bout enhances the translocation of gut-derived phenolics into the circulation. A comparator group of runners (N=20) ingesting the flavonoid supplement for two weeks will be included (2.5 h run, 70% VO2max).
2. 2.SECONDARY: Data from this study will determine if 2-weeks supplementation of the Reoxcyn flavonoid supplement is a sufficient time period to increase circulating levels of gut-derived phenolics, extending data collected from the previous 12-week community trial.

Conditions

Exercise and Gut-derived Phenolics

Keywords

exercise; flavonoids; gut permeability; gut-derived phenolics

Outcome Measures

Primary Outcomes (1)

• Plasma gut-derived phenolics

  Biotransformed flavonoids by gut bacteria after ingestion

  Pre- and post-2 weeks supplementation, post-exercise, 24-h post-exercise

Secondary Outcomes (1)

• Urine sugars

  24 h urine collection

Study Arms (2)

Flavonoid

EXPERIMENTAL

Flavonoid supplement

Dietary Supplement: Flavonoid supplement

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Interventions

Flavonoid supplement DIETARY_SUPPLEMENT

2-weeks ingestion of flavonoid supplement

Flavonoid

Placebo DIETARY_SUPPLEMENT

2-week ingestion of placebo supplement

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Females and males, 18 to 50 years of age
• Body mass index \<35 kg/m2 (i.e., not moderately or severely obese)
• Body weight of 100 pounds and greater
• Willing to consume during the study less than 5 servings/day fruits and vegetables, less than 2 cups/day coffee, and no green tea.
• Willing to avoid use of non-steroidal anti-inflammatory drugs (NSAIDs), and all dietary and herbal supplements for the 2-week study (and starting one week prior to the study).
• Walkers: Regular history of walking (\>100 min/week totaling all walking, both short or long duration episodes) and capable of walking 45 min briskly on a treadmill
• Runners: History of participating in 10 km to 42.2 km races and capable of running for 2.5 h on a treadmill.
• Non-smoker.
• Generally healthy and without chronic disease including cardiovascular disease (e.g., heart disease, stroke), cancer, type 1 and 2 diabetes, rheumatoid arthritis.
• Willing to maintain normal physical activity and diet habits, and make no formal attempts to lose weight during the 2-week study.

You may not qualify if:

• Use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) \[e.g. ibuprofen (Advil, Motrin, Nuprin), naproxen (Aleve, Naprosyn), and COX-2 inhibitors (Celebrex)\] within one week prior to the study, and/or intent to use these drugs during the 2-week period of the study.
• Regular use of fish oil supplements, omega 3 supplements, or omega 3-based drugs (Lovaza, etc.) during the past one to two weeks and plans to use these supplements during the study.
• Pregnant or breastfeeding.
• Currently on a weight reducing plan or using weight-loss medications (e.g., selective serotonin reuptake inhibitors, steroids, Ritalin, appetite suppressors, Xenical, Diethylpropion), and plans to continue during the 2-week period of the study.
• Regular use of large dose nutrient, herbal, and dietary supplements during the past one to two weeks, and plans to use these during the 2-week period of the study.

Sponsors & Collaborators

• Appalachian State University: lead
• Reoxcyn Discoveries Group: collaborator

Study Sites (1)

North Carolina Research Campus, Human Performance Lab

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

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: Flavonoid or placebo in capsules
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, parallel group design

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: June 5, 2017
• Primary Completion: August 29, 2017
• Study Completion: August 30, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)