What is the mechanism of action of this treatment?

Dietary inorganic nitrate, commonly found in beetroot juice, enhances nitric oxide (NO) bioavailability, which is crucial for various physiological functions. NO improves mitochondrial respiration, muscle tissue perfusion, and contractile function, leading to enhanced exercise capacity and efficiency. For healthy subjects, this means better physical performance, reduced fatigue, and potentially improved cardiovascular health. These benefits are particularly relevant for athletes or individuals looking to optimize their physical fitness and overall well-being.

What side effects are associated with this type of intervention?

Dietary inorganic nitrate, commonly found in beetroot juice, is used to increase nitric oxide bioavailability, which can enhance exercise performance and muscle function. Known side effects of such treatments include gastrointestinal discomfort, such as bloating and diarrhea, and a potential fishy aftertaste. Additionally, there may be variations in response based on sex, as most studies have focused on male subjects, limiting the applicability to females.

What prior FDA approvals exist?

FDA-approved treatments that increase nitric oxide bioavailability include nitrates like nitroglycerin and phosphodiesterase inhibitors such as sildenafil. These medications are primarily used for cardiovascular conditions like angina, heart failure, and pulmonary hypertension. There are no specific FDA approvals for treatments aimed solely at increasing nitric oxide bioavailability in healthy subjects.

What other types of research exist?

<ol> <li>Beetroot Juice: Rich in nitrates, it is already known for increasing NO bioavailability and improving exercise performance.</li> <li></li> </ol> L-Arginine: An amino acid that serves as a precursor to NO, potentially enhancing NO production and improving vascular function. 3. L-Citrulline: Another amino acid that converts to L-arginine in the body, thereby boosting NO levels. 4. Pomegranate Extract: Contains antioxidants that may enhance NO bioavailability and improve vascular health. 5. Dark Chocolate: Rich in flavonoids, which can increase NO production and improve endothelial function.

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Dietary Supplement

Beetroot Juice for Exercise Performance in Women

Phase 1

Waitlist Available

Led By Jason D. Allen, PhD

Research Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up male subjects (2 occasions)- it will be measured on day 5 of supplementation (placebo or nitrate). female subjects (4 times) - it will be measured between days 3-5 and 10-15 of their menstrual cycle in two different cycles.

Summary

This trial tests if beetroot juice, which boosts Nitric Oxide levels, improves exercise performance differently in men and women. It aims to see if men gain more power and if women resist fatigue better. The study involves 24 active individuals, split equally between men and women. Beetroot juice, rich in dietary nitrate, has been shown to improve exercise performance by enhancing tissue oxygenation and metabolic efficiency.

Who is the study for?

This trial is for men and women who are physically active but not highly-trained athletes. They must be in good health, with normal blood pressure (systolic: 120-129, diastolic: 80-84) and a normal BMI range (18.5-24.9). There should be no orthopedic issues that could affect their participation.

What is being tested?

The study is testing the effects of concentrated beet root juice versus a placebo on exercise efficiency, strength, and fatigue resistance. It aims to understand if there are differences between how males and females respond to dietary nitrate supplementation across the menstrual cycle.

What are the potential side effects?

Beet root juice may cause changes in urine or stool color due to its natural pigments. Other potential side effects include low blood pressure, stomach upset or discomfort.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ male subjects (2 occasions)- it will be measured on day 5 of supplementation (placebo or nitrate). female subjects (4 times) - it will be measured between days 3-5 and 10-15 of their menstrual cycle in two different cycles.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~male subjects (2 occasions)- it will be measured on day 5 of supplementation (placebo or nitrate). female subjects (4 times) - it will be measured between days 3-5 and 10-15 of their menstrual cycle in two different cycles.

This trial's timeline: 3 weeks for screening, Varies for treatment, and male subjects (2 occasions)- it will be measured on day 5 of supplementation (placebo or nitrate). female subjects (4 times) - it will be measured between days 3-5 and 10-15 of their menstrual cycle in two different cycles. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Muscle function - Maximal knee extensor speed and power determined using isokinetic dynamometry

Secondary study objectives

Oxygen consumption during a submaximal exercise

Time to exhaustion during a high intensity exercise bout on a cycle ergometer

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Dietary nitrateActive Control1 Intervention

The active treatment, beetroot juice (BEET IT, James White Drinks, Ipswich, UK), contains 6.2mmol of inorganic nitrate. Participants will continue supplementation until they complete all testing visits.

Group II: PlaceboPlacebo Group1 Intervention

The placebo beet root juice is made by the same company (BEET IT, James White Drinks, Ipswich, UK) and contains no inorganic nitrate.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Dietary inorganic nitrate, commonly found in beetroot juice, enhances nitric oxide (NO) bioavailability, which is crucial for various physiological functions. NO improves mitochondrial respiration, muscle tissue perfusion, and contractile function, leading to enhanced exercise capacity and efficiency. For healthy subjects, this means better physical performance, reduced fatigue, and potentially improved cardiovascular health. These benefits are particularly relevant for athletes or individuals looking to optimize their physical fitness and overall well-being.