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Time Restricted Eating for POTS
N/A
Recruiting
Led By Pam Taub, MD
Research Sponsored by University of California, San Diego
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age: 18-70 years old
Associated with related symptoms that are worse with upright posture and that improve with recumbency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline quality of life questionnaire at 14 weeks
Awards & highlights
Study Summary
This trial is testing whether time-restricted eating can improve symptoms in people with POTS, which is a condition characterized by fatigue, lightheadedness, and tachycardia.
Who is the study for?
This trial is for adults aged 18-70 with Postural Orthostatic Tachycardia Syndrome (POTS), who experience rapid heartbeat upon standing, have a BMI under 40, and eat over a 12-hour period daily. Excluded are those with diabetes, inflammatory diseases, recent major heart events or eating disorders, pregnant or breastfeeding women, and individuals on certain diets or medications affecting appetite.Check my eligibility
What is being tested?
The study investigates if time-restricted eating can improve symptoms of POTS by targeting mitochondrial and immune dysfunction. Participants will follow an eating schedule that confines their meals to specific hours of the day to see if this impacts their energy balance and immune health.See study design
What are the potential side effects?
Time-restricted eating may lead to hunger outside of designated eating times, potential changes in mood or energy levels due to altered meal patterns, and possible digestive discomfort as the body adjusts to new eating schedules.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 70 years old.
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My symptoms get worse when I stand and better when I lie down.
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I have been diagnosed with POTS based on heart rate changes and symptoms.
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My heart rate increases significantly when I stand up.
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I am between 18 and 65 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline mitochondrial function at 14 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline mitochondrial function at 14 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Conduct a pilot clinical trial with POTS patients to assess if TRE can improve Quality of Life.
Other outcome measures
Exploratory Outcome: Assess whether POTS patients demonstrate persistent inflammatory responses and immune cell exhaustion
Exploratory Outcome: Characterize mitochondrial function in POTS patients
Trial Design
1Treatment groups
Experimental Treatment
Group I: Time restricted eatingExperimental Treatment1 Intervention
Everyone in this arm will implement a daily 8-10-hour window within which they must consume their calories. They will also be required to log their caloric intake through the use of a smartphone app.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time restricted eating
2021
N/A
~130
Find a Location
Who is running the clinical trial?
Dysautonomia InternationalOTHER
5 Previous Clinical Trials
394 Total Patients Enrolled
5 Trials studying Postural Orthostatic Tachycardia Syndrome
394 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
University of California, San DiegoLead Sponsor
1,120 Previous Clinical Trials
1,521,382 Total Patients Enrolled
1 Trials studying Postural Orthostatic Tachycardia Syndrome
37 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Pam Taub, MDPrincipal InvestigatorProfessor of Medicine
8 Previous Clinical Trials
1,151 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently in a program to lose or manage your weight.I am currently being treated for cancer, except for non-melanoma skin cancer.My symptoms get worse when I stand and better when I lie down.You currently use a lot of tobacco or illegal drugs, or have been treated for alcohol abuse in the past.You have a history of an eating disorder.You have a score higher than 16 on the Epworth Sleepiness Scale.You have been diagnosed with depression using the Beck Depression Inventory (BDI-II).You are planning to travel to a place with a time difference of more than 3 hours during the study.I have had surgery to help manage my weight.I have an irregular heartbeat that is not under control.You are on a special diet for medical reasons, like Celiac disease.You weigh less than 40 kilograms per square meter for every meter of your height.I am taking medication that affects my appetite.I am between 18 and 70 years old.You work different hours, like at night.You are responsible for taking care of someone who needs help during the night.My thyroid medication dose was adjusted in the last 3 months.I have been diagnosed with POTS based on heart rate changes and symptoms.I have been diagnosed with type I diabetes.You have a mental health condition that is not being managed well.I don't have conditions or take medications that cause rapid heartbeat when standing.I have had symptoms for more than six months.You have a period of not eating for more than 12 hours before the study starts.I have had a serious heart problem in the last year.I have a history of adrenal gland problems.I have advanced chronic kidney disease or am on dialysis.I have a diagnosed inflammatory or rheumatologic condition.You have diabetes with a specific blood sugar level (HbA1c > 7.0%).I have been using insulin in the past 6 months.I have a history of HIV/AIDS.I have had symptoms for more than six months.I have a history of cirrhosis.My heart rate increases significantly when I stand up.I am between 18 and 65 years old.I have been diagnosed with POTS.
Research Study Groups:
This trial has the following groups:- Group 1: Time restricted eating
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.
Who is eligible to join this scientific endeavor?
"This clinical investigation is recruiting 25 adults who have struggled with cannabis misuse, aged between 18 and 70. To qualify for the study, applicants must meet the following criteria: Age (18-65 years old), BMI (< 40 kg/m2), Upright posture heart rate increase of ≥30 bpm or >40 bpm (for those under 20 years old) from a supine position, Associated symptoms that worsen in an upright state but improve when lying down, Chronic signs lasting more than six months not caused by other conditions nor medications known to bring about orthostatic tachycardia and Daily eating period exceeding 12 hours."
Answered by AI
Are there any volunteer opportunities for this research project?
"As recorded on clinicaltrials.gov, this medical trial is open for recruitment and was initially uploaded to the website on July 1st 2022 with its last update taking place August 3rd 2022."
Answered by AI
Can minors participate in this investigation?
"This clinical trial is open to individuals aged 18 or older, with a maximum age of 70."
Answered by AI
How many participants are engaging in the research project?
"Affirmative, data from clinicaltrials.gov proves that this medical experiment is actively seeking participants. The trial was initially shared on July 1st 2022 and updated as recently as August 3rd. This investigation requires 25 individuals to be enrolled at one particular site."
Answered by AI
Who else is applying?
What state do they live in?
Texas
California
How old are they?
18 - 65
What site did they apply to?
Altman Clinical and Translational Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
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