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

25 Participants Needed

Trial Summary

What is the purpose of this trial?

The mechanisms underlying POTS are not well understood. Though heterogeneous in nature, patients often present with symptoms that include fatigue, orthostatic lightheadedness and tachycardia, "brain fog", shortness of breath, and sleep disruption. The central mediator that links observations in disease entities similar to POTS is energy use and balance driven by mitochondrial health. Mitochondrial dysfunction (i.e. respiration defects, reactive oxygen species (ROS) generation, and structural abnormalities) are hallmarks of currently defined syndromes that resemble POTS symptomatology. Many patients with POTS have underlying immune system dysfunction, which, when treated, may improve the patient's overall health. Though autoimmunity has been demonstrated in POTS, overall immune dysregulation may be broader and include immune cell exhaustion and persistent inflammatory cytokine responses. Immune dysfunction including cellular exhaustion and persistent inflammation has been linked to mitochondrial function. Therefore, we hypothesize that a unifying feature of POTS results from latent or continued mitochondrial/immune dysfunction which then impacts multi-organ energy imbalance and immune homeostasis. Understanding and targeting mitochondria utilizing established, novel, and directed approaches including time-restricted eating (TRE) will help to unravel common etiologies and help us to better diagnose, manage, and treat 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 data supports the effectiveness of the treatment Time Restricted Eating for POTS?

Research shows that time-restricted eating, a form of intermittent fasting, can help reduce body weight and blood pressure in adults with overweight and obesity. It may also improve cardiovascular risk factors, which could be beneficial for conditions like POTS that affect heart function. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Research shows that time-restricted eating, where people eat within an 8-hour window and fast for 16 hours, is generally safe for adults with obesity. Studies found no significant changes in adverse events, blood counts, or eating patterns, suggesting it can be a safe way to help with weight loss. ^{1 3 5 6 7}

How is time-restricted eating different from other treatments for POTS?

Time-restricted eating (TRE) is unique because it involves eating only during a specific window of time each day, which can help improve cardiovascular health and reduce body weight. Unlike other treatments that might involve medication, TRE focuses on changing eating patterns to potentially benefit heart health and metabolism. ^{1 2 3 7 8}

Research Team

Pam Taub, MD

Principal Investigator

Professor of Medicine

Taylor Doherty, MD

Principal Investigator

Professor of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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 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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Association of time-restricted feeding, arterial age, and arterial stiffness in adults with metabolic syndrome. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating Alters Food Intake Patterns, as Prospectively Documented by a Smartphone Application. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Design and Implementation of a Time-Restricted Eating Intervention in a Randomized, Controlled Eating Study. [2023]

5. Switzerland 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. [2021]

6. Canada pubmed.ncbi.nlm.nih.gov

Safety of 8-h time restricted feeding in adults with obesity. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating to Improve Cardiovascular Health. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Metabolic Efficacy of Time-Restricted Eating in Adults: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. [2022]