Beetroot Juice: a Natural Aid for Boosting the Health Benefits of Exercise in Post-menopausal Women? (BEETBOOST)
Menopause and ageing bring several changes to women's health, partly due to a decline in the hormone estrogen. This reduction affects multiple systems in the body, including muscles and bones, and also influences the production of nitric oxide, a molecule that plays a key role in regulating blood flow and blood pressure. An reduced ability to produce nitric oxide is associated with higher blood pressure and an increased risk of cardiovascular and metabolic diseases.
Many women also experience lower levels of physical activity and changes in body composition during midlife, such as increased body fat and reduced muscle mass and strength, which may further decrease exercise capacity.
This PhD project investigates whether a simple, natural strategy, combining exercise with beetroot juice, can help postmenopausal women achieve greater benefits from exercise. Beetroot juice is naturally rich in nitrates, which the body can convert into nitric oxide, thereby enhancing blood flow. Exercise itself also stimulates nitric oxide production, and together these approaches may have additive or even synergistic effects.
The study examines whether consuming beetroot juice before exercise can enhance training adaptations and health outcomes in postmenopausal women. Key outcomes include cardiovascular function, body composition, musculoskeletal function, and aerobic capacity.
Some evidence suggests that beetroot juice may amplify the body's response to exercise, which could be particularly beneficial for postmenopausal women, who often face greater barriers to physical activity. By exploring this combined approach, the project aims to evaluate a safe, non-pharmacological strategy to improve physical function and overall health in women after menopause.
연구 개요
상태
정황
상세 설명
Menopause and ageing are associated with significant changes in women's health, partly due to the decline in estrogen production. Estrogen contributes to the regulation of cardiovascular function and metabolism, as well as the maintenance of musculoskeletal health, in part by stimulating nitric oxide (NO) production, a key signalling molecule involved in vascular function. Ageing per se is also linked to reduced NO bioavailability, meaning that postmenopausal women may experience a combined decline driven by both lower estrogen levels and age-related physiological changes. Together, these factors are associated with an increased risk of cardiometabolic dysfunction, reduced exercise tolerance, and potential declines in quality of life.
This PhD project examines a non-pharmacological approach: the combination of beetroot juice (BRJ) supplementation and exercise (BRJ+EX). Both BRJ and exercise can enhance NO production through different pathways, which may result in additive effects. This approach may be relevant for postmenopausal women, in whom both estrogen-related and age-related NO production are reduced.
The study will investigate whether BRJ+EX can influence exercise-induced adaptations, including changes in cardiometabolic health, body composition, musculoskeletal function, and exercise tolerance, compared with placebo beetroot juice combined with exercise (BRJplacebo+EX). Some recent evidence suggests that BRJ ingestion prior to combined exercise training may enhance certain training responses, which could be particularly relevant for postmenopausal women who may experience barriers to exercise. Thus, building on this evidence, this study aim to test the hypothesis that pre-workout ingestion of BRJ enhances exercise adaptions in post-menopausal women comprehensively.
Furthermore, given the lack of information on the impact of hormone replacement therapy (HRT), this study also aim to explore whether HRT modulates exercise adaptions by also including women taking HRT.
Overall, this project aims to contribute to the evidence base on non-pharmacological approaches to supporting health and physical function in postmenopausal women.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Ann-Katrin Grotle, PhD
- 전화번호: +4790960580
- 이메일: ann-katrin.grotle@hvl.no
연구 연락처 백업
- 이름: Brit Jorun Liseth, MSc
- 전화번호: +4790013513
- 이메일: brit.jorun.fossan.liseth@hvl.no
연구 장소
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Bergen, 노르웨이, 5063
- 모병
- Western Norway University of Applied Sciences
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연락하다:
- Ann-Katrin Grotle, PhD
- 전화번호: +4790960580
- 이메일: ann-katrin.grotle@hvl.no
-
수석 연구원:
- Ann-Katrin Grotle, PhD
-
연락하다:
- Brit Jorun Liseth, MSc
- 전화번호: +4790013513
- 이메일: brit.jorun.fossan.liseth@hvl.no
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Self-reported biological female and postmenopausal (≥12 months of amenorrhea)
- Aged 50-70 years
- Body mass index (BMI) 25-39.9 kg/m²
- No contraindications to exercise
- Physically inactive (<150 minutes/week of moderate-intensity activity)
- Able to walk on a treadmill and ambulate without limitations
- Adequate proficiency in Norwegian to complete questionnaires
- Willingness and ability to comply with the study schedule and visits
Exclusion Criteria:
- Known allergy to nitrates or beetroot juice
- Current smoker or use of nicotine/tobacco products
- Resting blood pressure <90/60 mmHg
- Hypertension greater than stage II (≥160/100 mmHg, ESH criteria)
- Use of prescription medications affecting heart rate (e.g., systemic β-adrenergic blockers) or nitrate availability (e.g., nitrates, proton pump inhibitors)
- History of cardiovascular disease (e.g., myocardial infarction, stroke, ischemic heart disease, peripheral artery disease, valvular disease, or aortic aneurysm)
- Symptoms suggestive of heart disease (e.g., chest pain or dyspnea)
- Major metabolic disease (e.g., type 1 or type 2 diabetes) or thyroid disorders
- Recent cancer diagnosis or treatment (within the past 5 years)
- Significant orthopedic limitations or other contraindications to exercise
- Diagnosed cognitive impairment
- Planned travel or elective surgery that would interfere with adherence to the intervention
- Psychological or social factors that may interfere with study participation
- Residing beyond a reasonable distance from the study site (logistical constraints)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Nitrate rich
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Intervention includes 3 sessions per week of combined strength and resistance exercise.
Two of the sessions are supervised, while the third session is unsupervised-home-based.
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위약 비교기: Nitrate depleted
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Intervention includes 3 sessions per week of combined strength and resistance exercise.
Two of the sessions are supervised, while the third session is unsupervised-home-based.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Maximal oxygen uptake
기간: Before and after 12 weeks of intervention
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Maximal oxygen uptake (VO₂max) will be measured using a standardized incremental exercise test to volitional exhaustion on a cycle ergometer, with continuous analysis of expired gases (indirect calorimetry).
VO₂max will be determined as the highest VO₂ value achieved during the test and reported as ml/min and ml/kg/min.
Validity of test will be determined based on established criteria such as a plateau in oxygen uptake despite increasing workload, a respiratory exchange ratio above a predefined threshold (e.g., ≥1.10), and/or attainment of age-predicted maximal heart rate.
When a clear plateau is not observed, the highest recorded VO₂ (VO₂peak) will be reported.
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Before and after 12 weeks of intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Skeletal muscle strength
기간: Before and after 12 weeks of intervention
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Maximal upper- and lower-body strength will be determined using a Keiser pneumatic leg press and chest press machine as well as handgrip dynamometer using standardized protocols.
Maximal strength for will be defined as the highest load achieved and will be reported in kilograms (kg).
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Before and after 12 weeks of intervention
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Exercise economy
기간: Before and after 12 weeks of intervention
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Exercise economy will be assessed during a standardized incremental lactate threshold test using indirect calorimetry.
Oxygen consumption (VO₂) will be measured during submaximal exercise stages below the lactate threshold, and exercise economy will be defined as the steady-state oxygen cost at a given absolute workload.
Exercise economy will be reported as oxygen consumption relative to workload (e.g., mL·kg-¹·min-¹ or L·min-¹ at a standardized power output or speed), with lower oxygen cost indicating better exercise economy.
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Before and after 12 weeks of intervention
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Lean mass
기간: Before and after 12 weeks of intervention
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Lean mass changes will be assessed using validated body composition analysis methods, including dual-energy X-ray absorptiometry (DXA), according to site-specific standard operating procedures.
Measurements will be performed at baseline and after 12 weeks of exercise training under standardized conditions.
Total and regional lean mass will be measured and reported in kilograms and % of total mass.
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Before and after 12 weeks of intervention
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Resting blood pressure
기간: Before and after 12 weeks of intervention
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Resting blood pressure control will be assessed after >15 minutes of supine rest under standardized condition by measuring systolic and diastolic blood pressure five times during a 10 minute resting period, with at least one minute between measurements.
A validated automated device will be used.
The average of five systolic and diastolic blood pressure measurements will be used for reporting and is reported in mmHg.
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Before and after 12 weeks of intervention
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Blood pressure reactivity
기간: Before and after 12 weeks of intervention
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Blood pressure reactivity will be assessed as the change in mean arterial pressure (MAP) in response to standardized stress tasks (e.g., isometric handgrip exercise and cold pressor test).
Reactivity will be quantified as the difference between resting baseline MAP and peak MAP achieved during each stress task and will be reported in mmHg.
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Before and after 12 weeks of intervention
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Arterial stiffness
기간: Before and after 12 weeks of intervention
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Arterial stiffness will be assessed by carotid-femoral pulse wave velocity (cfPWV) in accordance with established expert consensus guidelines.
Pulse wave velocity will be determined from the transit time of the arterial pulse waveform between the carotid and femoral arteries, measured in the supine position following a standardized rest period.
Arterial stiffness will be reported as cfPWV in meters per second (m/s), with higher values indicating greater arterial stiffness.
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Before and after 12 weeks of intervention
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Endothelial function
기간: Before and after 12 weeks of intervention
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Endothelial function will be assessed by brachial artery flow-mediated dilation (FMD) in accordance with current expert consensus guidelines.
FMD will be measured using high-resolution ultrasound following a standardized period of forearm occlusion and subsequent reactive hyperemia.
Endothelial function will be quantified as the percentage change in brachial artery diameter from baseline to peak post-occlusion diameter and reported as FMD (%), with higher values indicating better endothelial function.
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Before and after 12 weeks of intervention
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Pelvic floor strength
기간: Before and after 12 weeks of intervention
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Pelvic floor muscle strength will be assessed using a vaginal pressure manometer (Camtech manometer).
Participants will be examined in a supine position and covered with a towel for privacy.
A small pressure-sensitive vaginal probe will be inserted into the vagina, and participants will perform three maximal voluntary pelvic floor muscle contractions.
The highest recorded value will be used for analysis and reported in cmH₂O, with higher values indicating greater muscle strength.
The Camtech manometer has demonstrated validity and normative reference values are available for the relevant age group.
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Before and after 12 weeks of intervention
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Fat mass
기간: Before and after 12 weeks of intervention
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Fat mass changes will be assessed using validated body composition analysis methods, including dual-energy X-ray absorptiometry (DXA), according to site-specific standard operating procedures.
Measurements will be performed at baseline and after 12 weeks of exercise training under standardized conditions.
Total and regional fat mass will be measured and reported in kilograms and %.
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Before and after 12 weeks of intervention
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Visceral fat
기간: Before and after 12 weeks of intervention
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Visceral adipose tissue will be assessed from whole-body dual-energy X-ray absorptiometry (DXA) scans using manufacturer-specific software algorithms for estimation of abdominal visceral fat.
Visceral adipose tissue will be reported in grams (g) or volume (cm³), with higher values indicating greater visceral fat accumulation.
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Before and after 12 weeks of intervention
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Fasting triglyserides
기간: Before and after 12 weeks of intervention
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Fasting triglyceride concentrations will be assessed from venous blood samples collected following an overnight fast.
Blood samples will be analyzed using standard enzymatic laboratory methods.
Fasting triglyceride levels will be reported in mmol/L, with lower values indicating a more favorable lipid profile.
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Before and after 12 weeks of intervention
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Fasting glukose
기간: Before and after 12 weeks of intervention
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Fasting glucose concentrations will be assessed from venous blood samples collected following an overnight fast.
Blood samples will be analyzed using standard clinical laboratory methods.
Fasting glucose levels will be reported in mmol/L, with lower values indicating better glycemic control.
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Before and after 12 weeks of intervention
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ann-Katrin Grotle, PhD, Western Norway University of Applied Sciences
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .