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Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females on Hormone Therapy

ConditionsPostmenopausal Female PatientsVasomotor SymptomsMenopausal Hormone Therapy
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-75
SponsorUniversity of Virginia

About this trial

This study is examining whether short-term supplementation with inorganic nitrate in the form of beetroot juice can enhance vascular function in postmenopausal females taking hormone therapy compared to placebo.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Postmenopausal females aged 45-75, defined as having not had a menstrual cycle for at least 1 year

BMI <35 kg/m2

Currently taking hormone replacement therapy with transdermal estrogen (spray/gel/patches) combined with progesterone for at least 3 months

MHT regimen started within 10 years of last menses

Disqualifiers

Smokers within the last 5 years

Weight unstable (loss/gain of more than 3kg in the past 3 months) or currently taking weight loss medications

Any medical condition that prevents the subject from exercising safely

Diabetes

Trial design

Design model

Parallel

Treatments tested in this trial

  • Moderate Intensity Exercise (MIE)

    Other intervention

    MIE bout of exercise will be completed after 3 days of supplementation with BRJ/placebo. This intensity will be equivalent to the watts at lactate threshold.

  • High intensity exercise (HIE)

    Other intervention

    HIE bout of exercise will be completed after 3 days of supplementation with BRJ/placebo. This intensity will be equivalent to the watts at Lactate threshold + 75% ∆ (VO2peak - LT).

  • Control (No exercise)

    Other intervention

    The control session will involve passive rest.

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Beetroot juiceExperimental treatment 3 interventions
Group B: PlaceboPlacebo comparator 3 interventions

Trial outcomes

Primary outcomes

1

Vascular Endothelial Function (Flow-Mediated Dilation [FMD])

FMD- Participants will be placed in a supine position with their right forearm slightly extended and supinated, and their legs straight. The arteries will be imaged using a high-resolution 7.5 MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation, and continuously for 3 minutes post-occlusion. An EKG trigger will be used to capture images during end-diastole of the cardiac cycle.

Time frame
At baseline on each condition and following 3-day supplementation before and after exercise/rest conditions up to 3 hours post (60, 90, 120, 150, and 180 min post)
2

Skin microvascular function using post-occlusive reactive hyperemia (PORH)

Skin microvascular function will be measured using Moor Instruments' FLPI-2 laser speckle imaging system. PORH will also be measured during the FMD measurement. Baseline measures will be captured, and the cuff will be inflated for 5 minutes, with the post-occlusion reactive period being measured. The laser positioned above the forearm skin will measure skin blood flow at all these time points.

Time frame
PORH will only be measured at baseline to assess baseline microvascular function
3

Vascular Endothelial Function (Pulse wave analysis and velocity [PWA/V])

PWA/V- These measures will be calculated using the SphygmoCor XCEL system (AtCor Medical). This system will provide arterial stiffness, central, and peripheral pressure waveforms.

Time frame
PWA/V was measured at baseline on each condition and following 3-day supplementation PWA before and after exercise/rest conditions up to 3 hours post (60, 90, 120, 150, and 180 min post)
4

Plasma/ Saliva nitrate and nitrite

Plasma/Saliva samples will be collected to assess changes in plasma nitrate and nitrite following either BRJ or placebo and in different exercise and control conditions.

Time frame
At baseline and before each exercise condition.

Secondary outcomes

1

Oral Nitrate reducing capacity

To assess the oral microbiome's ability to reduce nitrate to nitrite, the participant will rinse their mouth with a solution of potassium nitrate and ultra-pure water for five minutes. The rinsed solution will be collected into a 50ml Falcon tube. The nitrite concentration will be measured to determine ONRC

Time frame
Before and after 3 days of supplementation in each condition.
2

Biomarker analysis: concentration of Inflammatory/oxidative stress markers in fasting blood plasma, as well as hormonal measures

The investigators plan to assess various markers of inflammation, oxidative stress, and hormonal markers. A fasting blood sample will be collected.

Time frame
At baseline and 3 days after BRJ or placebo.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Virginia

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: