Beetroot Supplementation in Women Enjoying Exercise Together

NCT ID: NCT04370756

Last Updated: 2024-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-30
• Study Completion Date: 2023-05-26

Brief Summary

This study seeks to determine the feasibility of an exercise training progression with the consumption of beetroot juice prior to exercise in postmenopausal women. Results from this investigation will be used to determine preliminary effect sizes for exercise training only (control) and exercise training + beetroot juice (EX+BR) to inform the direction of larger randomized clinical trials on pre-post changes in measures of cardiovascular health and endothelial function.

Detailed Description

An increasing body of evidence has supported acute benefits of beetroot juice including lowered blood pressure and greater muscle oxygenation during exercise. Thus, consumption of beetroot juice prior to exercise may alter the perceptual difficulty for a given exercise bout -- possibly resulting in an individual exercising at a greater intensity (without the commensurate increase in discomfort). The investigators propose that repeated exposure to a relatively greater exercise stimulus (via beetroot juice) may elicit more robust cardio-metabolic adaptations compared to exercise training alone (i.e., without beetroot juice). Possible findings could inform a larger randomized clinical trial to determine if pre-exercise beetroot juice supplementation is an effective strategy to promote health related benefits.

The investigators will examine the effects of pre-exercise beetroot juice coupled with 8 weeks of supervised exercise training among post-menopausal (75 and younger) women. Qualified individuals will be required to complete an initial screening visit as well as three baseline visits (Visits 1-2). Participants will undergo a series of tests including: dual-energy X-ray absorptiometry scan, bioelectrical impedance analysis, exhaled fraction of nitric oxide, health-related questionnaires, and pulse wave velocity. Participants will also be asked to perform leg muscle function and walking tests. Following the completion of Visits 1-2, participants will attend supervised exercise training sessions 3x/week for 8 weeks. Within 2-6 days from the last exercise training session, participants will repeat the same measurement procedures.

The primary objective involves elements of feasibility (e.g., recruitment, retention, adherence, and adverse event) and to generate preliminary effect sizes for 8 weeks of exercise training for two groups: control and EX+BR. Secondary objectives involve preliminary effect sizes for pre-post changes in distance covered during the 6-minute walk test, changes in endothelial-dependent vasodilation, and biomarkers of cardiovascular health.

Conditions

Aging; Postmenopause; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Ex only

Participants will perform 8 weeks of supervised exercise training (EX).

Group Type: ACTIVE_COMPARATOR

Exercise Training

Intervention Type: OTHER

Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week.

EX + BR

Participants will perform 8 weeks of supervised exercise training (EX) plus pre-exercise consumption of beetroot juice (BR).

Group Type: EXPERIMENTAL

Beetroot Juice

Intervention Type: DIETARY_SUPPLEMENT

Participants randomly assigned to the EX + BR group will consume 140 mL beetroot juice containing approximately 12 mmol of nitrate 3 hours prior to the supervised exercise training component.

Exercise Training

Intervention Type: OTHER

Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week.

Interventions

Beetroot Juice

Participants randomly assigned to the EX + BR group will consume 140 mL beetroot juice containing approximately 12 mmol of nitrate 3 hours prior to the supervised exercise training component.

Intervention Type: DIETARY_SUPPLEMENT

Exercise Training

Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Post-menopausal women (self-report)
• Between the ages of 18-75 years (confirmed by birth date listed on participant's driver license at screening visit)
• Physician's clearance for study participation (required prior to baseline testing)
• English-speaking
• Body mass index between 25.0 to 39.9 kg/m^2 (measured on-site at screening visit)
• Able to ambulate without assistance

Exclusion Criteria

• Unable to provide informed consent
• 18-75 of age (confirmed by birth date listed on participant's driver license at screening visit)
• Body mass index < 25.0 or >39.9 kg/m^2 (measured on-site at screening visit)
• Greater than stage II hypertension (i.e. >159/99 mm Hg)
• Current smoker (self-report)
• Currently pregnant, lactating, or trying to become pregnant (self-report)
• Habitually exercise training >= 3 times per week (self-report)
• Significant orthopedic limitations or other contraindications to strenuous exercise
• Live or work >50 miles from Bloomington study site or do not have transportation to the study site
• Anticipate elective surgery during the study period
• Plan to move residence or travel out of the local area during the study period
• History of major metabolic disease (e.g. Type I diabetes, Type II diabetes, thyroid disorders)
• Current use of anti-coagulants (e.g. Coumadin or Warfarin)
• Current use of prescription medications that affect heart rate or blood vessel dilation (e.g. phosphodiesterase-5 inhibitors, proton pump inhibitors, systemic adrenergic blockers, nitrates, calcium channel blockers, hormone replacement therapy) (self-report and confirmed on-site at screening visit)
• Psychological or social characteristic that would interfere with their ability to fully participate in the study (i.e. taking longer than allowed time to complete cognitive assessments)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

IU Health University Hospital

UNKNOWN

Sponsor Role: collaborator

Indiana CTSI Clinical Research Center

UNKNOWN

Sponsor Role: collaborator

Bloomington Crossfit

UNKNOWN

Sponsor Role: collaborator

Indiana University

OTHER

Sponsor Role: lead

Responsible Party

Stephen J. Carter, Ph.D.

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen J Carter, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Bloomington

Locations

Indiana University

Bloomington, Indiana, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1907026303

Identifier Type: -

Identifier Source: org_study_id