Beetroot Supplementation in Women Enjoying Exercise Together

NCT04370756 | Completed DMC

• 1 other identifier: 1907026303
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Postmenopause; Obesity

Keywords

Beetroot juice; Postmenopause; Exercise training; Endothelial function

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Distance covered during a six-minute walk test

  Baseline, post-intervention

• Soluble endothelial microparticles

  Baseline, post-intervention

Study Arms (2)

Ex only

ACTIVE COMPARATOR

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

Other: Exercise Training

EX + BR

EXPERIMENTAL

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

Dietary Supplement: Beetroot Juice; Other: Exercise Training

Interventions

Beetroot Juice 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.

EX + BR

Exercise Training OTHER

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

EX + BR; Ex only

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to provide informed consent
• 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)

Sponsors & Collaborators

• Indiana University: lead
• IU Health University Hospital: collaborator
• Indiana CTSI Clinical Research Center: collaborator
• Bloomington Crossfit: collaborator

Study Sites (1)

Indiana University

Bloomington, Indiana, 47401, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Stephen J Carter, Ph.D.

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Group allocation will be determined at random using a computer-based number in blocks of 2 to ensure equal between-group distribution (i.e. n = 2 Ex only; n = 2 BR+EX). Each number will be kept in a sealed envelope until completion of Visits 1-2.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Participants will be enrolled in small (n = 4) cohorts or "waves" to facilitate social support and adherence to the supervised exercise training sessions. We anticipate having 9 waves to successfully reach our target n. This assumes that each wave will have 4 participants, hence, 4 participants x 9 waves = 36 total participants. Subsequently, participants will be randomly selected to: 1) control (EX only) or 2) EX + Beetroot Juice.

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: May 1, 2020
• Study Start: January 30, 2020
• Primary Completion: May 26, 2023
• Study Completion: May 26, 2023
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)