NCT06598488

Brief Summary

This study aims to explore the effects of short-term beetroot juice (BRJ) supplementation on cardiovascular health in post-menopausal women. The primary focus is to determine whether BRJ, rich in nitrates that increase nitric oxide (NO) bioavailability, can reduce blood pressure at rest and during exercise, as well as improve oxygen uptake during maximal exercise. Given the increased cardiovascular risk in post-menopausal women due to the loss of estrogen's protective effects, this research seeks to provide a novel, non-pharmacological intervention to enhance cardiovascular function during exercise in this population.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

September 9, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

September 13, 2024

Last Update Submit

March 8, 2026

Conditions

Keywords

Beetroot juice

Outcome Measures

Primary Outcomes (3)

  • Blood pressure

    After 4 days of intervention

  • Blood pressure reactivity

    After 4 days of intervention

  • Maximal oxygen consumption

    After 4 days of intervention

Study Arms (2)

Nitrate rich beetroot juice

EXPERIMENTAL

4 days of nitrate rich beetroot juice ingestion (Beet it)

Dietary Supplement: Beetroot juice

Nitrate depleted beetroot juice

PLACEBO COMPARATOR

4 days of nitrate depleted beetroot juice ingestion (Beet it)

Dietary Supplement: Beetroot juice placebo

Interventions

Beetroot juiceDIETARY_SUPPLEMENT

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.

Nitrate rich beetroot juice
Beetroot juice placeboDIETARY_SUPPLEMENT

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.

Nitrate depleted beetroot juice

Eligibility Criteria

AgeUp to 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Norway University of Applied Sciences

Bergen, 5063, Norway

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 13, 2024

First Posted

September 19, 2024

Study Start

September 9, 2025

Primary Completion

December 16, 2025

Study Completion

December 16, 2025

Last Updated

March 10, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations