- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06598488
Beetroot Juice: A Natural Boost for Cardiovascular Health in Postmenopausal Women? (BEETBOOST)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to evaluate the short-term effects of beetroot juice (BRJ) supplementation on blood pressure and oxygen uptake during exercise in post-menopausal women. Post-menopausal women are at increased risk of cardiovascular disease due to the loss of estrogen, which plays a critical role in nitric oxide (NO) production, a key regulator of blood vessel function and blood pressure. BRJ, rich in dietary nitrates, is converted into NO in the body and may offer a natural means to improve cardiovascular health.
The primary objective is to investigate whether short-term BRJ supplementation can reduce resting and exercise blood pressure and enhance oxygen uptake during maximal exercise, compared to a placebo. The study will also explore the relationship between these cardiovascular responses and blood biomarkers, including nitrate/nitrite levels and inflammatory cytokines.
The study design is a randomized, double-blind, placebo-controlled crossover trial. Post-menopausal women will be randomized into either the BRJ or placebo group, consuming BRJ or nitrate-depleted juice for 4 days, followed by a 7-day washout period before switching to the alternate group. Participants will undergo testing to measure blood pressure and oxygen uptake at rest and during exercise at baseline and after each intervention.
This research is novel and clinically significant, as it explores a non-pharmacological approach to mitigate cardiovascular risks in post-menopausal women. By improving cardiovascular function, this study aims to offer a new strategy for addressing age- and menopause-related increases in blood pressure and declines in exercise capacity.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Bergen, Norway, 5063
- Western Norway University of Applied Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Females under the age of 65
- Self-reported absence of menstrual cycle for >1 year
- BMI <30 kg/m2.
- Able to walk on a treadmill and cycle on a stationary bike without problems.
- Proficient in Norwegian and able to provide informed consent.
Exclusion criteria:
- Current or recent (last 5 years) regular smoker or user of nicotine products
- Addictions to alcohol or illegal drugs
- Allergy or intolerance (s) to nitrate or BRJ supplement.
- Diagnosed with cardiovascular disease (e.g., previous acute myocardial infarction or stroke, peripheral artery disease, heart failure), renal, or respiratory (e.g., asthma, sleep apnea).
- Regular usage of nitrate supplements, including beetroot juice
- Hormone replacement therapy.
- Uncontrolled high blood pressure (e.g., resting systolic and diastolic blood pressure >160/110 mmHg)
- Problems with very low blood pressure (e.g., severe dizziness upon standing)
- Diagnosed with diabetes (type 1 or type 2).
- Using blood pressure or glucose-lowering medications
- Close family (parents, siblings, children) history of sudden cardiac death at an early age (<55 for men, <65 for women)
- Judgment by a medical provider that exercise poses an undue burden or risk.
- Cognitive or psychiatric impairment
- Lack of proficiency in Norwegian language oral or writing skills that will hamper the ability to participate in the interventions and fill out questionnaires.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Nitrate rich beetroot juice
4 days of nitrate rich beetroot juice ingestion (Beet it)
|
Beetroot juice will be consumed 2 times a day for 4 days before testing plus one shot on experimental testing day 1,5 hours before arrival.
|
|
Placebo Comparator: Nitrate depleted beetroot juice
4 days of nitrate depleted beetroot juice ingestion (Beet it)
|
Beetroot juice will be consumed 2 times a day for 4 days before testing plus one shot on experimental testing day 1,5 hours before arrival.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Blood pressure
Time Frame: After 4 days of intervention
|
After 4 days of intervention
|
|
Blood pressure reactivity
Time Frame: After 4 days of intervention
|
After 4 days of intervention
|
|
Maximal oxygen consumption
Time Frame: After 4 days of intervention
|
After 4 days of intervention
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 730456 (Other Identifier: Regional Ethics Committee.)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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