NCT07572877

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
78mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Feb 2026Jan 2033

Study Start

First participant enrolled

February 11, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 19, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2033

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

3.9 years

First QC Date

March 19, 2026

Last Update Submit

May 11, 2026

Conditions

Keywords

exercisebeetroot juicestrength trainingendurance trainingcardiometabolic healthmuscleskeletal functionexercise performancebody composition

Outcome Measures

Primary Outcomes (1)

  • Maximal oxygen uptake

    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.

    Before and after 12 weeks of intervention

Secondary Outcomes (5)

  • Skeletal muscle strength

    Before and after 12 weeks of intervention

  • Exercise economy

    Before and after 12 weeks of intervention

  • Lean mass

    Before and after 12 weeks of intervention

  • Resting blood pressure

    Before and after 12 weeks of intervention

  • Blood pressure reactivity

    Before and after 12 weeks of intervention

Other Outcomes (7)

  • Arterial stiffness

    Before and after 12 weeks of intervention

  • Endothelial function

    Before and after 12 weeks of intervention

  • Pelvic floor strength

    Before and after 12 weeks of intervention

  • +4 more other outcomes

Study Arms (2)

Nitrate rich

EXPERIMENTAL
Dietary Supplement: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training

Nitrate depleted

PLACEBO COMPARATOR
Dietary Supplement: Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training

Interventions

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.

Nitrate depletedNitrate rich

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Norway University of Applied Sciences

Bergen, 5063, Norway

RECRUITING

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Ann-Katrin Grotle, PhD

    Western Norway University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ann-Katrin Grotle, PhD

CONTACT

Brit Jorun Liseth, MSc

CONTACT

Study Design

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

Study Record Dates

First Submitted

March 19, 2026

First Posted

May 7, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2033

Last Updated

May 13, 2026

Record last verified: 2026-05

Locations