Time Restricted Eating for POTS

Overseen By Marissa Dzotsi, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Must not be taking: Insulin, Appetite medications

Disqualifiers: Diabetes, Rheumatologic disease, Tobacco, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores time-restricted eating (TRE) as a potential treatment for Postural Orthostatic Tachycardia Syndrome (POTS), a condition causing fatigue, dizziness, and rapid heartbeat when standing. Researchers aim to determine if limiting eating to an 8-10 hour window each day can improve symptoms by addressing energy use and balance issues linked to mitochondrial health, the energy producers within cells. Individuals who have experienced POTS symptoms for over six months and currently have longer daily eating periods may be suitable for the trial. Participants will use a smartphone app to track their caloric intake. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new insights and treatments for POTS.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are currently taking medications that affect appetite or if you have had recent changes in thyroid medication.

What prior data suggests that time-restricted eating is safe for POTS patients?

Research has shown that time-restricted eating (TRE), where eating occurs only during an 8- to 10-hour period each day, can improve life quality and heart health in people with POTS. Studies have found that this eating pattern can reduce inflammation and enhance the immune and nervous systems. Participants in these studies reported feeling better overall.

However, not all results are positive. One study found a connection between an 8-hour TRE schedule and a higher risk of death from heart disease, suggesting TRE might not be safe for everyone, especially those with heart issues.

Overall, many people seem to handle TRE well, with some benefits for those with POTS. As always, consulting a healthcare provider before starting any new eating plan is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Time restricted eating is unique because it offers a non-pharmaceutical approach to managing Postural Orthostatic Tachycardia Syndrome (POTS). Unlike current treatments that often involve medications like beta-blockers or lifestyle changes focused on increased fluid and salt intake, this method involves limiting food consumption to an 8-10-hour window each day. Researchers are excited about this approach because it could help regulate blood volume and autonomic function in a natural way, potentially reducing symptoms without the side effects associated with medications. Additionally, using a smartphone app to log caloric intake allows for personalized monitoring and adherence, making it easier for patients to manage their condition.

What evidence suggests that time-restricted eating might be an effective treatment for POTS?

Research shows that time-restricted eating (TRE), where eating occurs only during an 8-10 hour period each day, may help people with postural orthostatic tachycardia syndrome (POTS). In this trial, all participants will follow a TRE regimen. Studies have found that TRE can improve quality of life and heart rate. It also helps lower inflammation and strengthens the immune system. Researchers believe TRE improves mitochondrial health, enhancing energy production in cells. This boost in energy use and immune function could help manage POTS symptoms like tiredness and lightheadedness. ^{1 2 3 4 6}

Who Is on the Research Team?

Taylor Doherty, MD

Principal Investigator

Professor of Medicine

Pam Taub, MD

Principal Investigator

Professor of Medicine

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My symptoms get worse when I stand and better when I lie down.

You weigh less than 40 kilograms per square meter for every meter of your height.

I have been diagnosed with POTS based on heart rate changes and symptoms.

Exclusion Criteria

You are currently in a program to lose or manage your weight.

Pregnant or breast-feeding women

I am currently being treated for cancer, except for non-melanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants implement a daily 8-10-hour window for caloric intake using time-restricted eating (TRE) for 12 weeks

12 weeks

Participants log caloric intake through a smartphone app

Follow-up

Participants are monitored for changes in mitochondrial function and immune response

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Time restricted eating

Trial Overview 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.

How Is the Trial Designed?

Group I: Time restricted eating Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

Dysautonomia International

Collaborator

Trials

6

Recruited

420+

Published Research Related to This Trial

In a study of 50 adults with overweight and obesity, participants successfully reduced their eating window from an average of 16 hours to about 12 hours over a 90-day time-restricted eating (TRE) intervention, leading to significant weight loss and reductions in waist circumference and blood pressure.

The TRE approach, which required no dietary counseling and was monitored through a smartphone app, showed a feasible and effective way to improve eating patterns and health outcomes in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Smartphone Intervention to Promote Time Restricted Eating Reduces Body Weight and Blood Pressure in Adults with Overweight and Obesity: A Pilot Study. Prasad, M., Fine, K., Gee, A., et al.[2021]

Time-restricted eating (TRE) significantly reduces body weight and fat mass, with an average weight loss of 1.60 kg and fat loss of 1.48 kg in a meta-analysis of 17 studies involving 899 participants.

TRE particularly benefits overweight individuals, leading to improvements in lipid profiles, including lower triglycerides, total cholesterol, and LDL cholesterol, although it does not significantly affect waist circumference or blood pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Liu, L., Chen, W., Wu, D., et al.[2022]

In a study of 95 adults with metabolic syndrome, time-restricted feeding (TRF) during Ramadan led to significant reductions in arterial stiffness and improved cardiovascular markers, such as pulse wave velocity and central systolic pressure.

The Ramadan fasting group showed notable improvements in arterial health, suggesting that TRF could be a beneficial dietary strategy for enhancing cardiovascular health and potentially extending lifespan.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome. Alinezhad-Namaghi, M., Eslami, S., Nematy, M., et al.[2023]

This study is the first to evaluate the effects of time-restricted eating (TRE) on weight loss in a controlled manner, comparing it to a usual eating pattern (UEP) while ensuring both groups consumed the same number of calories and identical diets.

Participants aged 21-69 with prediabetes and obesity were monitored closely, allowing for a rigorous assessment of how meal timing impacts weight change without altering caloric intake.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. White, K., Wu, B., Pilla, SJ., et al.[2023]

In a 12-week study involving 14 adults with obesity, time-restricted feeding (8-hour eating window) led to a significant weight loss of about 2 kg, indicating potential efficacy for weight management.

Despite the weight loss, the study found no significant changes in the diversity or composition of the gut microbiome, suggesting that time-restricted feeding may not impact gut health in terms of microbial diversity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. Gabel, K., Marcell, J., Cares, K., et al.[2022]

In a 12-week study involving 23 obese adults, time-restricted feeding (TRF) with an 8-hour eating window was found to be safe, as there were no significant changes in self-reported adverse events or disordered eating patterns.

The study suggests that TRF can effectively support weight loss in obese individuals without negatively impacting their health or body image perception.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. Gabel, K., Hoddy, KK., Varady, KA.[2019]

In a 12-week study involving 20 adults with a BMI of 25 kg/m2 or higher, time-restricted eating (TRE) significantly reduced the frequency of eating occasions by 28% compared to only 12% in the non-TRE group, indicating a more structured eating pattern.

TRE participants also reported a notable decrease in both high and low-quality snacks and caffeinated beverage intake, suggesting that this eating pattern not only aids in weight loss but also promotes healthier dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. Malaeb, S., Harindhanavudhi, T., Dietsche, K., et al.[2022]

Time-restricted eating (TRE) can lead to a weight loss of 1-4% over 1-16 weeks in individuals with obesity, primarily due to unintentional reductions in daily calorie intake of about 350-500 kcal.

TRE is effective in improving cardiovascular health by lowering fat mass, blood pressure, triglyceride levels, and markers of oxidative stress, and it is considered safe with few adverse events reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. Gabel, K., Cienfuegos, S., Kalam, F., et al.[2021]

Citations

1. nature.com nature.com/articles/s41598-025-16836-2

Time-restricted eating improves quality of life, heart rate ... Time-restricted eating (TRE), which limits caloric intake to an 8–10 h daily window, has been shown to decrease inflammation and improve immune, ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12148283/

Time-Restricted Eating Improves Quality of Life, Heart Rate ... Time-restricted eating (TRE), which limits caloric intake to an 8-10 hour daily window, has been shown to decrease inflammation and improve immune, autonomic, ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41038948/

Time-restricted eating improves quality of life, heart rate, ... Time-restricted eating improves quality of life, heart rate, and mitochondrial function in patients with postural orthostatic tachycardia ...

4. newsroom.heart.org newsroom.heart.org/news/8-hour-time-restricted-eating-linked-to-a-91-higher-risk-of-cardiovascular-death

8-hour time-restricted eating linked to a 91% higher risk of ... A study of over 20,000 adults found that those who followed an 8-hour time-restricted eating schedule, a type of intermittent fasting, had a 91% ...

5. researchgate.net researchgate.net/publication/396130379_Time-restricted_eating_improves_quality_of_life_heart_rate_and_mitochondrial_function_in_patients_with_postural_orthostatic_tachycardia_syndrome_An_open-label_pilot_study

Time-restricted eating improves quality of life, heart rate, ... Time-restricted eating improves quality of life, heart rate, and mitochondrial function in patients with postural orthostatic tachycardia ...

6. tctmd.com tctmd.com/news/time-restricted-eating-tightens-glycemic-control-patients-metabolic-syndrome

Time-Restricted Eating Tightens Glycemic Control in ... A personalized lifestyle intervention that promotes time-restricted eating (TRE) during an 8- to 10-hour window “modestly improves” glycemic regulation.