Beetroot Juice Resistance Training Older Adults

July 12, 2022 updated by: Gary Miller, Wake Forest University

Effect of Beetroot Juice on Body Composition, Physical Function, Muscle Strength, and Peak Oxygen Consumption in Resistance Trained Older Adults Consuming a Protein Supplement

The present study compared the effects of a nitrate containing beetroot juice supplement (BRJ+Nitrate) vs. a placebo (Control) on total and regional fat free mass, quadriceps muscle strength, lower body mobility, and VO2peak in healthy, older adults undergoing a 10-week long progressive resistance training program with protein supplementation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to provide own transportation to study testing visits and intervention
  • Able to read and write in English
  • Nondiabetic, i.e. fasting glucose < 126 mg/dl
  • Sedentary (less than 60 minutes of moderate intensity structured physical activity each week and occurs in no more than 10 minute blocks and not participating in a resistance exercise training program)
  • Willingness to provide informed consent and participate in intervention. Participants with diagnosed depression were permitted to participate provided that they have been medically stable without medication change for at least 3 months.

Exclusion Criteria:

  • Smoking or use of chewing tobacco
  • Involved in another intervention research study
  • Diabetic (type 1 or 2)
  • Atrophic gastritis
  • Hypo- or hyperthyroidism
  • Gout or history of kidney stones
  • History of hypotension
  • Premenopausal (women)
  • Aversion to study-related testing procedures
  • Allergy/sensitivity/aversion to beetroot beverages or protein supplement
  • Medical conditions with contraindications for engaging in resistance training program or taking the protein supplement
  • Systemic, uncontrolled diseases (diabetes, recent (last 6 months) or current treatment of cancer, thyroid disorders, cardiovascular disease, COPD, or inflammatory bowel diseases)
  • Use of any of the following medications: phosphodiesterase type 5 inhibitors, nitroglycerin or nitrate preparations, proton pump inhibitors, or medications for hypothyroidism
  • Potential inability to complete the tasks required for the protocol as well as conditions that may interfere with interpretation of results including: inability to ambulate, severe congestive heart failure or severe cardiovascular disease, neoplasm for practical and neurophysiologic reasons
  • Individuals with contraindications for performing a graded exercise test or have medical contraindications for participating in a scheduled exercise training program
  • Individuals more than 300 pounds or less than 125 pounds due to DEXA weight limits and possibility of exceeding recommended daily nitrate dose of 7 mg/kg body weight, respectively.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: BRJ+Nitrate
This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 380 mg of nitrate plus a 15 dose of whey protein after each exercise session.
Dietary supplement: BRJ+Nitrate
Participants in this group drank a 70 mL bottle of Beet It Sport drink with nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program
PLACEBO_COMPARATOR: Control
This arm underwent a 3 days a week, 10 weeks of resistance exercise training program and consumed for a 70 mL bottle of beetroot juice containing 0 mg of nitrate plus a 15 dose of whey protein after each exercise session.
Dietary supplement: Control
Participants in this group drank a 70 mL bottle of Beet It Sport drink without nitrate plus 15 grams of whey protein 3 days a week following a resistance exercise training program

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Whole body fat free mass
Time Frame: Collected at baseline
Mass of fat free tissue
Collected at baseline
Whole body fat mass
Time Frame: Collected at baseline
Mass of fat tissue
Collected at baseline
Thigh muscle
Time Frame: Collected at baseline
Volume of thigh muscle
Collected at baseline
Thigh intermuscular fat
Time Frame: Collected at baseline
Volume of fat in the thigh muscle
Collected at baseline
Thigh subcutaneous fat
Time Frame: Collected at baseline
Volume of subcutaneous fat in the thigh
Collected at baseline
Visceral fat
Time Frame: Collected at baseline
Volume of visceral fat
Collected at baseline
Muscle strength
Time Frame: Collected at baseline
Strength of quadriceps muscle at a speed of 60 degrees per second
Collected at baseline
400 meter walk
Time Frame: Collected at baseline
Time to walk 400 meters
Collected at baseline
Stair climb time
Time Frame: Collected at baseline
Time to ascend and descend 12 stairs
Collected at baseline
Peak oxygen consumption
Time Frame: Collected at baseline
Peak oxygen consumed at maximal exercise during graded exercise testing
Collected at baseline
Whole body fat free mass
Time Frame: Collected at 10-weeks
mass of fat free tissue
Collected at 10-weeks
Whole body fat mass
Time Frame: Collected at 10-weeks
Mass of fat tissue
Collected at 10-weeks
Thigh muscle
Time Frame: Collected at 10-weeks
Volume of thigh muscle
Collected at 10-weeks
Thigh intermuscular fat
Time Frame: Collected at 10-weeks
Volume of fat in the thigh muscle
Collected at 10-weeks
Thigh subcutaneous fat
Time Frame: Collected at 10-weeks
Volume of subcutaneous fat in the thigh
Collected at 10-weeks
Visceral fat
Time Frame: Collected at 10-weeks
Volume of visceral fat
Collected at 10-weeks
Muscle strength
Time Frame: Collected at 10-weeks
Strength of quadriceps muscle at a speed of 60 degrees per second
Collected at 10-weeks
400 meter walk
Time Frame: Collected at 10-weeks
Time to walk 400 meters
Collected at 10-weeks
Stair climb time
Time Frame: Collected at 10-weeks
Time to ascend and descend 12 stairs
Collected at 10-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2014

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB00025941

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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