Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06527248
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-24
Brief Title:
Nitrate Exercise and Vascular Function in Midlife Women
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Dietary Nitrate From Beetroot Juice on Vascular Function and Adaptations to Exercise Training in Postmenopausal Women a Randomized Placebo-controlled Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Womens-Beet
Brief Summary:
The purpose of this clinical study in women after menopause is to investigate whether the daily intake of nitrate from beetroot juice over 12 weeks enhances the positive effect of exercise training on vascular function blood pressure and physical performance
The risk of cardiovascular diseases CVD increases with advancing age and women are particularly affected In women the decline in the sex hormone oestrogen in the blood circulation with menopause contributes to impaired vascular function and an increased CVD risk in part through increased inflammatory processes oxidative stress and a reduced bodys own production of nitric oxide NO NO is a signaling molecule that is important for vascular function Endurance-based exercise training is a key lifestyle strategy to prevent CVD However studies indicate that exercise is less effective in terms of its health-promoting adaptations in women after menopause as compared with men of similar age
This study investigates the effect of exercise training in combination with the intake of nitrate-rich beetroot juice on functions of the cardiovascular system Nitrate is a nitrogen compound that is found naturally in plant foods eg beetroot juice and is converted to NO in the human body Results of previous studies indicate vasodilatory blood pressure-lowering and performance-enhancing effects as well as positive influences on inflammatory processes and oxidative stress following nitrate intake The hypothesis is that nitrate intake concomitant to training promotes training adaptations and further improves vascular function blood pressure and physical performance compared to training without nitrate intake
For the study 54 untrained postmenopausal women with the ages between 45 and 65 years will be recruited and randomly allocated into two groups Both groups will undergo 12 weeks of endurance-based exercise training One group will receive nitrate-rich beetroot juice and the other nitrate-depleted beetroot juice as placebo Vascular function blood pressure maximum oxygen uptake and blood biomarkers for nitrate metabolism inflammation status and oxidative stress will be examined
The anticipated study results will provide new insights into whether nitrate as a training adjunct improves health-promoting training adaptations in women after menopause The overall aim is to improve the cardiovascular health and performance of middle-aged women and reduce their increased CVD risk
The risk of cardiovascular diseases CVD increases with advancing age and women are particularly affected In women the decline in the sex hormone oestrogen in the blood circulation with menopause contributes to impaired vascular function and an increased CVD risk in part through increased inflammatory processes oxidative stress and a reduced bodys own production of nitric oxide NO NO is a signaling molecule that is important for vascular function Endurance-based exercise training is a key lifestyle strategy to prevent CVD However studies indicate that exercise is less effective in terms of its health-promoting adaptations in women after menopause as compared with men of similar age
This study investigates the effect of exercise training in combination with the intake of nitrate-rich beetroot juice on functions of the cardiovascular system Nitrate is a nitrogen compound that is found naturally in plant foods eg beetroot juice and is converted to NO in the human body Results of previous studies indicate vasodilatory blood pressure-lowering and performance-enhancing effects as well as positive influences on inflammatory processes and oxidative stress following nitrate intake The hypothesis is that nitrate intake concomitant to training promotes training adaptations and further improves vascular function blood pressure and physical performance compared to training without nitrate intake
For the study 54 untrained postmenopausal women with the ages between 45 and 65 years will be recruited and randomly allocated into two groups Both groups will undergo 12 weeks of endurance-based exercise training One group will receive nitrate-rich beetroot juice and the other nitrate-depleted beetroot juice as placebo Vascular function blood pressure maximum oxygen uptake and blood biomarkers for nitrate metabolism inflammation status and oxidative stress will be examined
The anticipated study results will provide new insights into whether nitrate as a training adjunct improves health-promoting training adaptations in women after menopause The overall aim is to improve the cardiovascular health and performance of middle-aged women and reduce their increased CVD risk
Detailed Description:
Wider research context
Advancing age is a major risk factor for cardiovascular diseases CVD In women the decline in the sex hormone oestrogen with menopause contributes to impaired vascular function and an increased CVD risk in part via a reduced bioavailability of the endothelium-derived signaling molecule nitric oxide NO chronic low-grade inflammation and increased oxidative stress Aerobic or endurance exercise training is a key lifestyle strategy to prevent CVD However data indicate that exercise is less effective for improving cardiovascular health in postmenopausal women as compared with men of similar age Oestrogen treatment may restore vascular training adaptations but is associated with health risks The main objective of this research is to examine whether dietary nitrate as a nutritional adjuvant to regular exercise could be an innovative lifestyle intervention to favorably modulate vascular training adaptations and health in midlife women This research expands upon findings by the investigators and others showing that inorganic nitrate from vegetables exerts benefits on physical function and cardiovascular health by increasing NO availability through the nitrate-nitrite-NO pathway and by attenuating inflammation and oxidative stress
Objectives and hypotheses
The investigators propose a clinical study to examine whether the daily consumption of nitrate-rich beetroot juice concomitant with aerobic exercise training improves vascular function blood pressure and cardiovascular fitness in postmenopausal women more effectively as compared with nitrate-depleted beetroot juice consumption as placebo The hypothesis is that the increased nitrate intake favorably modulates the systemic inflammatory and oxidative stress status and promotes cardiovascular health-related training outcomes
Methods
This study will involve a prospective randomized placebo-controlled parallel-group design 54 untrained postmenopausal women 45-65 years will be recruited and randomized into two groups Both groups will undergo 12 weeks of endurance-based exercise training The training will consist of a supervised training program that meets contemporary guidelines on aerobic physical activity One group will receive nitrate-rich beetroot juice containing 400 mg nitrate based on available evidence on the physiological and ergogenic benefits of nitrate and the other nitrate-depleted beetroot juice placebo on the background of a low-nitrate diet and an otherwise unaltered lifestyle 42 participants 21 per group will be required to complete the study based on powersample size calculations with the forearm blood flow response to acetylcholine as primary endpoint Secondary endpoints and additional measures will include 24 h-ambulatory blood pressure maximal oxygen uptake and blood inflammation and oxidative stress biomarkers
Originality and innovation
It is anticipated that this work will provide important new evidence on the efficacy of dietary nitrate to improve the training responsiveness vascular function and cardiovascular health in women after menopause The objective of such a combined nutritional-training approach is to promote preserve or restore physiological function and delay or possibly prevent the transition to functional limitations and CVD
Research funding and cooperation arrangements
This clinical research is funded by the Austrian Science Fund FWF grant DOI 1055776KLP1075624 It is based on close collaborations between the University of Vienna and the Medical University of Vienna both Austria with the Department of Clinical Pharmacology at the Medical University of Vienna as the clinical trial center and Prof MD Michael Wolzt as the coordinating physician of the trial center The sponsor is the University of Vienna as represented by the Principal Investigator Dr Oliver Neubauer Priv-Doz Department of Nutritional Sciences University of Vienna Further national collaborations involve the groups of Prof MD Daniel König Prof Karl-Heinz Wagner both University of Vienna and Prof Viktoria Weber University for Continuing Education Krems Austria International collaborations include Dr Catherine P Bondonno Prof Jonathan M Hodgson both Edith Cowan University Prof Richard J Woodman Flinders University all Australia Prof Karsten Krüger Justus Liebig University of Giessen Germany and Prof Jason D Allen University of Virginia USA
Advancing age is a major risk factor for cardiovascular diseases CVD In women the decline in the sex hormone oestrogen with menopause contributes to impaired vascular function and an increased CVD risk in part via a reduced bioavailability of the endothelium-derived signaling molecule nitric oxide NO chronic low-grade inflammation and increased oxidative stress Aerobic or endurance exercise training is a key lifestyle strategy to prevent CVD However data indicate that exercise is less effective for improving cardiovascular health in postmenopausal women as compared with men of similar age Oestrogen treatment may restore vascular training adaptations but is associated with health risks The main objective of this research is to examine whether dietary nitrate as a nutritional adjuvant to regular exercise could be an innovative lifestyle intervention to favorably modulate vascular training adaptations and health in midlife women This research expands upon findings by the investigators and others showing that inorganic nitrate from vegetables exerts benefits on physical function and cardiovascular health by increasing NO availability through the nitrate-nitrite-NO pathway and by attenuating inflammation and oxidative stress
Objectives and hypotheses
The investigators propose a clinical study to examine whether the daily consumption of nitrate-rich beetroot juice concomitant with aerobic exercise training improves vascular function blood pressure and cardiovascular fitness in postmenopausal women more effectively as compared with nitrate-depleted beetroot juice consumption as placebo The hypothesis is that the increased nitrate intake favorably modulates the systemic inflammatory and oxidative stress status and promotes cardiovascular health-related training outcomes
Methods
This study will involve a prospective randomized placebo-controlled parallel-group design 54 untrained postmenopausal women 45-65 years will be recruited and randomized into two groups Both groups will undergo 12 weeks of endurance-based exercise training The training will consist of a supervised training program that meets contemporary guidelines on aerobic physical activity One group will receive nitrate-rich beetroot juice containing 400 mg nitrate based on available evidence on the physiological and ergogenic benefits of nitrate and the other nitrate-depleted beetroot juice placebo on the background of a low-nitrate diet and an otherwise unaltered lifestyle 42 participants 21 per group will be required to complete the study based on powersample size calculations with the forearm blood flow response to acetylcholine as primary endpoint Secondary endpoints and additional measures will include 24 h-ambulatory blood pressure maximal oxygen uptake and blood inflammation and oxidative stress biomarkers
Originality and innovation
It is anticipated that this work will provide important new evidence on the efficacy of dietary nitrate to improve the training responsiveness vascular function and cardiovascular health in women after menopause The objective of such a combined nutritional-training approach is to promote preserve or restore physiological function and delay or possibly prevent the transition to functional limitations and CVD
Research funding and cooperation arrangements
This clinical research is funded by the Austrian Science Fund FWF grant DOI 1055776KLP1075624 It is based on close collaborations between the University of Vienna and the Medical University of Vienna both Austria with the Department of Clinical Pharmacology at the Medical University of Vienna as the clinical trial center and Prof MD Michael Wolzt as the coordinating physician of the trial center The sponsor is the University of Vienna as represented by the Principal Investigator Dr Oliver Neubauer Priv-Doz Department of Nutritional Sciences University of Vienna Further national collaborations involve the groups of Prof MD Daniel König Prof Karl-Heinz Wagner both University of Vienna and Prof Viktoria Weber University for Continuing Education Krems Austria International collaborations include Dr Catherine P Bondonno Prof Jonathan M Hodgson both Edith Cowan University Prof Richard J Woodman Flinders University all Australia Prof Karsten Krüger Justus Liebig University of Giessen Germany and Prof Jason D Allen University of Virginia USA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None