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Behavioural Intervention
Fasting for High Blood Pressure
N/A
Waitlist Available
Led By Toshia R Myers, PhD
Research Sponsored by TrueNorth Health Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Awards & highlights
Study Summary
This trial will test if water-only fasting is a safe and effective treatment for high blood pressure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 7-40 days after baseline, up to 3 to 20 days after end-of-fast, 6-weeks after end of refeed, 12-months after 6-weeks follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine number of treatment-associated of grade 1-4 adverse events as assessed by CTCAE v5.0
Secondary outcome measures
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on change in systolic blood pressure (SBP)
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on dietary adhernece
Examine the feasibility of using fasting and refeeding in the treatment of stage 1 and 2 hypertension based on food acceptability
+1 moreOther outcome measures
Describe changes in 3-methyl-histidine from baseline
Describe changes in albumin from baseline
Describe changes in creatinine and total protein from baseline
+15 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Water-only Fasting GroupExperimental Treatment1 Intervention
Participants who voluntarily elect and are approved to water-only fast.
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Who is running the clinical trial?
TrueNorth Health FoundationLead Sponsor
2 Previous Clinical Trials
96 Total Patients Enrolled
Toshia R Myers, PhDPrincipal InvestigatorDirector
2 Previous Clinical Trials
96 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your kidneys are not working properly (creatinine over 2.0).You have a current inflammatory condition like lupus, multiple sclerosis, or inflammatory bowel disease.You cannot eat only plant-based foods for at least 48 hours before the fast starts.You can't lie still on your back for at least 10 minutes.You are between 30 and 75 years old.You have been diagnosed with mild or moderate high blood pressure (hypertension).Your blood sugar levels are within a certain range when you haven't eaten for a while, and your average blood sugar levels over the past few months are also within a specific range.You can go without eating any food and only drink water for at least 7 days.Your blood pressure is higher than 180/120 mmHg.You currently have cancer that is growing or spreading.You have had a stroke, heart attack, blood clot in your veins, irregular heart rhythm, or lung blood clot in the past year, or are taking blood thinners.You cannot stop taking your medications or supplements.You have metal implants in your abdomen.
Research Study Groups:
This trial has the following groups:- Group 1: Water-only Fasting Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please describe the type of person who would be ideal for this research project?
"Patients between the ages of 30 and 75 that suffer from hypertension are eligible for this study which is looking to enroll around 30 people."
Answered by AI
Are there any available spots left in this clinical trial for new patients?
"This particular clinical trial, as indicated on the website clinicaltrials.gov, is not recruiting patients at this moment in time. The study was first advertised on August 16th 2020 but was last updated on May 27th 2022. Although this research is not taking place presently, there are 785 other studies that are actively seeking participants right now."
Answered by AI
Does this research exclude senior citizens?
"This trial's inclusion criteria state that the youngest an eligible patient can be is 30 years old, while the oldest an eligible patient can be is 75 years old."
Answered by AI
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