NCT03522779

Brief Summary

To date, there are no published studies on the effects of tart cherry consumption on postprandial antioxidant and oxidative stress levels following a high-fat meal. Further, no one has looked at the effects of prior exercise on a high-fat meal that includes high phytonutrients like tart cherries. Therefore, the purpose of this study is to examine the effects of tart cherry consumption on antioxidant and oxidative stress levels in human plasma after consumption of a high-fat meal, as well as the postprandial impact of prior exercise in combination with tart cherry consumption on a high-fat meal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

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

November 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
10 months until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
Last Updated

May 11, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

January 19, 2017

Last Update Submit

April 30, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in Antioxidant levels

    Plasma will be tested for total anthocyanins content by HPLC-UV/VIS as well as HPLC-ESI-MS. Antioxidant capacity measurements will be performed by FRAP assays.

    Change from baseline to 3 hours postprandially

  • Change in oxidative stress levels

    Oxidative stress measurements will be performed by H-ORACFL assays.

    Change from baseline to 3 hours postprandially

Study Arms (4)

High-fat meal + placebo

PLACEBO COMPARATOR

Participants will complete a high-fat meal challenge with a placebo beverage.The placebo will be designed to match the tart cherry juice for volume and macronutrient content, but without the phytonutrient content of the tart cherries.The high-fat breakfast meal will consist of 2 Sausage Biscuits (McDonalds Corporation). Blood draws will then be obtained at 1, 2 and 3 hours postprandially for antioxidant and oxidative stress measurements.

Other: High-fat meal

High-fat meal + tart cherry

EXPERIMENTAL

Participants will complete a high-fat meal challenge with a tart cherry juice concentrate. 60 mL of montmorency tart cherry concentrate will be diluted with 100 mL of water.The high-fat breakfast meal will consist of 2 Sausage Biscuits (McDonalds Corporation). Blood draws will then be obtained at 1, 2 and 3 hours postprandially for antioxidant and oxidative stress measurements.

Dietary Supplement: Tart cherry JuiceOther: High-fat meal

Exercise + high-fat meal + placebo

PLACEBO COMPARATOR

Participants will perform an acute bout of submaximal aerobic exercise 15 hours prior to the high-fat meal test. The exercise will consist of 30 minutes of treadmill running at 70% of each participants' calculated heart rate reserve. The following morning participants will complete a high-fat meal challenge with a placebo beverage.The placebo will be designed to match the tart cherry juice for volume and macronutrient content, but without the phytonutrient content of the tart cherries.The high-fat breakfast meal will consist of 2 Sausage Biscuits (McDonalds Corporation). Blood draws will then be obtained at 1, 2 and 3 hours postprandially for antioxidant and oxidative stress measurements.

Other: High-fat mealOther: Exercise

Exercise + high-fat meal + tart cherry

EXPERIMENTAL

Participants will perform an acute bout of submaximal aerobic exercise 15 hours prior to the high-fat meal test. The exercise will consist of 30 minutes of treadmill running at 70% of each participants' calculated heart rate reserve.The following morning participants will complete a high-fat meal challenge with a tart cherry juice concentrate. 60 mL of montmorency tart cherry concentrate will be diluted with 100 mL of water.The high-fat breakfast meal will consist of 2 Sausage Biscuits (McDonalds Corporation). Blood draws will then be obtained at 1, 2 and 3 hours postprandially for antioxidant and oxidative stress measurements.

Dietary Supplement: Tart cherry JuiceOther: High-fat mealOther: Exercise

Interventions

Tart cherry JuiceDIETARY_SUPPLEMENT

Tart cherry juice will be used to compare antioxidant and oxidative stress levels in human plasma following a high fat meal.

Exercise + high-fat meal + tart cherryHigh-fat meal + tart cherry

A high fat meal will be given to elicit postprandial oxidative stress.

Exercise + high-fat meal + placeboExercise + high-fat meal + tart cherryHigh-fat meal + placeboHigh-fat meal + tart cherry

The exercise will consist of 30 minutes of treadmill running at 70% of each participants' calculated heart rate reserve.

Exercise + high-fat meal + placeboExercise + high-fat meal + tart cherry

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males, 18-30 years old, with normal body weight based on body mass index (BMI=18-24.9kg/m2) or are of normal weight based on body composition analysis using the DXA (14-24% body fat). Must also participate in 3 or more hours per week of exercise with 1.5 or more of those hours being aerobic exercise.

You may not qualify if:

  • Anyone with a chronic disease, medication use, digestive disorders, any supplement use, and anyone who will not consume tart cherry product. Anyone who is on a weight loss program, or planning to alter their current exercise program before the study would finish. Anyone who has lost or gained more than 5% of their body weight in the past 3 months. Anyone who has allergies to food, is vegan or vegetarian, or is on a medically prescribed diet.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Georgia - Department of Foods and Nutrition

Athens, Georgia, 30602, United States

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Jamie Cooper, PhD

    University of Georgia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jamie Cooper

Study Record Dates

First Submitted

January 19, 2017

First Posted

May 11, 2018

Study Start

November 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

May 11, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

No individual participant data will be shared.

Locations