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| Name | Class |
|---|---|
| IU Health University Hospital | UNKNOWN |
| Indiana CTSI Clinical Research Center | UNKNOWN |
| Bloomington Crossfit | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ex only | Active Comparator | Participants will perform 8 weeks of supervised exercise training (EX). |
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| EX + BR | Experimental | Participants will perform 8 weeks of supervised exercise training (EX) plus pre-exercise consumption of beetroot juice (BR). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen J Carter, Ph.D. | Indiana University, Bloomington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Bloomington | Indiana | 47401 | United States |
No IDP sharing plan
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2022 | Feb 24, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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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.
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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.
| Exercise Training | Other | Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week. |
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Blood samples will be analyzed for adhesion molecules (sICAM-1, sVCAM-1, sE-selectin). |
| Baseline, post-intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |