Beetroot Supplementation in Women Enjoying Exercise Together (BEE SWEET)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Aging; Postmenopause
• Intervention / Treatment: Other: Exercise Training; Dietary supplement: Beetroot Juice

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Stephen J Carter, Ph.D; Phone Number: 8128556593; Email: stjcarte@indiana.edu
• Study Contact Backup: Name: Emily B Long, M.S.; Phone Number: 8123691690; Email: longemi@iu.edu

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47401
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ex only; Participants will perform 8 weeks of supervised exercise training (EX).	Other: Exercise Training; Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week.
Experimental: EX + BR; Participants will perform 8 weeks of supervised exercise training (EX) plus pre-exercise consumption of beetroot juice (BR).	Other: Exercise Training; Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week.; Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	The number of eligible participants randomized per months of recruitment time.	24 months
Retention rate	The number of randomized participants who complete at least 17 (out of 24 possible) exercise training sessions.	8 weeks
Adherence to exercise training intervention	The percent of exercise sessions attended out of the 24 possible sessions.	8 weeks
Adherence to dietary nitrate intervention	Breath analysis of fractional exhaled nitric oxide concentrations.	8 weeks
Perceived difficulty of training sessions	Participants will report the perceived exertion at the end of exercise sessions using the Borg category ratio-10 scale that ranges from 0 "no exertion" to 10 "maximal exertion".	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance covered during a six-minute walk test	Participants will be asked to walk as far as possible at a preferred speed for six minutes according to ATS standards. Distance covered will be measured in meters.	Baseline, post-intervention
Soluble endothelial microparticles	Blood samples will be analyzed for adhesion molecules (sICAM-1, sVCAM-1, sE-selectin).	Baseline, post-intervention

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: IU Health University Hospital; Indiana CTSI Clinical Research Center; Bloomington Crossfit
• Investigators: Principal Investigator: Stephen J Carter, Ph.D., Indiana University, Bloomington

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2020
• Primary Completion (Actual): May 26, 2023
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: April 28, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: February 19, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Endothelial function; Exercise training; Postmenopause; Beetroot juice
• Other Study ID Numbers: 1907026303

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IDP sharing plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No