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Pre-conception Interventions to Reduce Blood Pressure Before Pregnancy

NCT05299450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2022-03-29

No results posted yet for this study

Summary

The study proposes to evaluate the feasibility of a preconception intervention comprising two proven interventions for reducing blood pressure; Beetroot juice; a source of dietary nitrate which reduces BP by 8/4mmHg after 4 weeks(6); Personalised resistance and endurance exercise programme (as per CMO recommendations) which reduces BP by \~10/5mm Hg over 8-12 weeks (7).

Conditions

  • Blood Pressure

Interventions

DIETARY_SUPPLEMENT

Beet It shots

In addition to the procedures for the control group, women will be supplied with 84 Beet-It shots which they will be asked to take every morning with breakfast for 12 weeks. Women below 60kg will be advised to take a proportion of the 'shot' in order to comply with European Commission Accepted Daily Intake for nitrate, the active ingredient, of 0-5mg/kg. https://www.beet-it.com/product/beet-it-sport-shot/

BEHAVIORAL

Exercise

In addition to the procedures for the control group, women will be supplied with gym membership for 12 weeks, 2 initial personal training sessions to design a personal exercise program followed by monthly personal training sessions.

OTHER

Control group

Women will be supplied with a wearable device to measure physical activity, weighing scales and a home blood pressure monitor. They will be asked to record minutes of physical activity, exercise undertaken, resting blood pressure, resting heart rate and weight daily for 12 weeks.

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    lead OTHER

Principal Investigators

  • Edward WS Mullins, PhD · Imperial College Healthcare NHS Trust

  • Cristoph C Lees, MD · Imperial College Healthcare NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-04-30
Completion
2021-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05299450 on ClinicalTrials.gov