NCT03258346

Brief Summary

A research study regarding the body's response to several weeks of training using short sprints and pomegranate juice supplementation

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

November 7, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2018

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

1.1 years

First QC Date

July 12, 2017

Last Update Submit

February 19, 2019

Conditions

Keywords

Pomegranate JuiceFunctional Tasks of Living

Outcome Measures

Primary Outcomes (7)

  • Change in muscle volume

    Volume of the thigh musculature as determined by MRI analysis.

    Baseline to 11 weeks

  • Change in sarcopenia obesity

    Intermuscular adipose tissue infiltration as measured by MRI

    Baseline to 11 weeks

  • Change in aerobic capacity

    VO2 Max on a cycle ergometer

    Baseline to 11 weeks

  • Change in anaerobic capacity

    The percent of maximal aerobic capacity that a subject can exercise at while not building up blood lactate

    Baseline to 11 weeks

  • Change in muscle fatigue

    Muscle aerobic stress as measured by near infrared spectroscopy

    Baseline to 11 weeks

  • Change in body composition

    Fat and fat free regional and total mass as measured by dual x-ray absorptiometry

    Baseline to 11 weeks

  • Change in maximal power production

    The ability to produce power as determined on the cycle ergometer and measured in watts

    Baseline to 11 weeks

Secondary Outcomes (6)

  • Change in cardiovascular risk factors

    Baseline to 11 weeks

  • Change in urolithins

    Baseline, 2 hrs after consuming first pomegranate or placebo supplement

  • Change in Microbiome

    Baseline, week 10 and week 15

  • Change in maximal isometric strength

    Baseline to 11 weeks

  • Change in functional tests of living

    Baseline to 11 weeks

  • +1 more secondary outcomes

Study Arms (2)

Exercise and Pomegranate Juice

EXPERIMENTAL

Exercise training with daily consumption of pomegranate juice containing polyphenols

Other: Inertial Load Cycling TrainingDietary Supplement: Pomegranate Juice

Exercise and Placebo

PLACEBO COMPARATOR

Exercise training with daily consumption of pomegranate juice with polyphenols removed

Other: Inertial Load Cycling TrainingDietary Supplement: Placebo

Interventions

Each session of training will require a total of 15 min with the total time actually exercising of only 60-120 sec. The first week will consist of performing 15 'sprints' on the ILE, beginning each sprint with 56 sec of rest. During week 2-5, subjects will rest 41 sec between sprints, completing 20 bouts. Finally, during weeks 6-10, subjects will take 26 s rest between sprints and complete 30 bouts).

Also known as: High intensity interval training
Exercise and PlaceboExercise and Pomegranate Juice
Pomegranate JuiceDIETARY_SUPPLEMENT

Subjects will consume 8oz of pomegranate juice daily for duration of study.

Exercise and Pomegranate Juice
PlaceboDIETARY_SUPPLEMENT

Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.

Exercise and Placebo

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • year old male and females

You may not qualify if:

  • not currently exercising regularly
  • meets criteria for MRI scanning at Imaging Research Center at UT Austin
  • history of heart disease
  • knee/hip joint problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Performance Laboratory

Austin, Texas, 78712, United States

Location

Related Publications (1)

  • Allen JR, Satiroglu R, Fico B, Tanaka H, Vardarli E, Luci JJ, Coyle EF. Inertial Load Power Cycling Training Increases Muscle Mass and Aerobic Power in Older Adults. Med Sci Sports Exerc. 2021 Jun 1;53(6):1188-1193. doi: 10.1249/MSS.0000000000002588.

MeSH Terms

Conditions

Sarcopenia

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Edward F Coyle, PhD

    UT Austin

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Pomegranate juice will be administered in double blind placebo controlled method. Coding will be established by POM Wonderful, LLC.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2017

First Posted

August 23, 2017

Study Start

November 7, 2017

Primary Completion

December 15, 2018

Study Completion

December 15, 2018

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations