Time-Restricted Feeding for Cardiovascular Disease Risk Factors

Overseen By Harper Basquill, B.S.N.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Diabetes medications, Weight loss drugs

Disqualifiers: Diabetes, Cancer, Cardiovascular disease, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

144 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether eating only during certain hours of the day (time-restricted eating) can help people with prediabetes control their blood sugar, lose weight, and improve heart health. Participants will follow different eating schedules for a few months to see which is most effective. Time-restricted eating (TRE) is an emerging dietary intervention for weight loss and metabolic health, with various studies investigating its effects on body weight, fat oxidation, and heart health.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are on diabetes medication or any medication that affects blood sugar or blood pressure rhythms.

What data supports the effectiveness of this treatment for cardiovascular disease risk factors?

Research suggests that time-restricted eating (TRE) can lead to mild weight loss and may improve cardiovascular health by lowering blood pressure and insulin resistance, which are risk factors for heart disease. ^{1 2 3 4 5}

Is time-restricted eating safe for humans?

Time-restricted eating (TRE) is generally considered safe for humans, as it involves eating within a specific time window each day. Studies have shown it can be followed without major safety concerns, although individual experiences may vary. ^{3 4 6 7 8}

How is time-restricted feeding different from other treatments for cardiovascular disease risk factors?

Time-restricted feeding (TRF) is unique because it involves eating only during a specific time window each day, which may help improve cardiovascular health by aligning eating patterns with the body's natural circadian rhythms. Unlike traditional treatments that might focus on medication or continuous calorie restriction, TRF emphasizes the timing of food intake, potentially offering a simpler and more natural approach to managing cardiovascular risk factors. ^{3 4 9 10 11}

Research Team

Courtney Peterson, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults aged 30-65 with a BMI of 27-43 who regularly wake up between 5-8 am and are prediabetic. It's not suitable for those with psychiatric conditions, significant diseases, recent weight fluctuations, or on certain medications affecting glucose or blood pressure.

Inclusion Criteria

I am between 30 and 65 years old.

My blood sugar levels indicate I am prediabetic.

You need to wake up at a regular time between 5 and 8 in the morning.

Exclusion Criteria

I have lost or gained more than 3 kg in the last 3 months.

My long-term medication dose hasn't changed in the last 3 months.

Pregnant or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to one of three time-restricted eating schedules for 8 weeks: Early TRE, Mid-day TRE, or Control Schedule. All food is provided and matched between groups.

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Control Schedule
• Early Time-Restricted Feeding
• Mid-day Time-Restricted Feeding

Trial Overview The study tests if eating within specific hours (Early TRF: ~8 am-3 pm; Mid-day TRF: ~1 pm - 8 pm) versus a control schedule (~8 am - 8 pm) affects blood sugar control, blood pressure, and cardiovascular risk factors over a period of 10 weeks.

Participant Groups

Group I: Mid-day TRE Experimental Treatment 1 Intervention

Group II: Early TRE Experimental Treatment 1 Intervention

Group III: Control Schedule Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Findings from Research

Time-restricted eating (TRE) has gained attention for its potential benefits on metabolic and cardiovascular diseases related to obesity, with a significant increase in research publications since 2016, totaling 414 studies.

Key research hotspots include the relationship between TRE and circadian rhythms, obesity, and metabolic diseases, indicating that TRE could be a promising approach for managing conditions like Type 2 diabetes and cardiovascular issues, though more high-quality studies are needed to fully understand its mechanisms and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bibliometric and visual analysis of time-restricted eating. Wang, S., Lin, X., Guan, Y., et al.[2022]

In a study of 90 participants with obesity, those who followed an early time-restricted eating (eTRE) schedule for at least 5 days a week lost an average of 3.7 kg and showed significant improvements in body fat, heart rate, insulin resistance, and glucose levels over 14 weeks.

While eTRE led to positive changes in weight and cardiometabolic health, participants reported less sleep and longer time to fall asleep, indicating a need for further research on the overall health implications of this eating pattern.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early time-restricted eating affects weight, metabolic health, mood, and sleep in adherent completers: A secondary analysis. Steger, FL., Jamshed, H., Bryan, DR., et al.[2023]

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]

In a pilot study of 50 participants with obesity over 12 weeks, time-restricted eating (TRE) led to a modest average weight loss of 2.6 kg, with greater weight loss observed in those who adhered to the regimen at least five days a week.

While TRE showed similar weight loss results compared to more complex weight management methods, it did not significantly impact blood pressure or lipid profiles, suggesting its primary benefit may be in weight management rather than metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time restricted eating as a weight loss intervention in adults with obesity. Przulj, D., Ladmore, D., Smith, KM., et al.[2021]

Time-restricted eating (TRE) can lead to a spontaneous reduction in energy intake by 20-30%, resulting in a small but significant weight loss of 1-4% in human subjects.

TRE may also improve cardiometabolic health by significantly lowering both systolic and diastolic blood pressure, as well as enhancing fasting insulin levels and reducing insulin resistance, independent of weight loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current research: effect of time restricted eating on weight and cardiometabolic health. Gabel, K., Varady, KA.[2022]

Time-restricted eating (TRE), which limits food intake to 6 to 10 hours during the active part of the day, has been shown to improve metabolic health and glucose tolerance in various models, including humans.

Most research on TRE has focused on starting the eating window in the morning, but this paper highlights potential challenges and metabolic effects of delaying the eating window, suggesting that timing may be crucial for maximizing benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? Heilbronn, LK., Regmi, P.[2021]

In a study involving 32 participants over six weeks, the Time-restricted Feeding (TRF) diet was found to be the most acceptable, with participants reporting it as the easiest to follow compared to Early Time-restricted Feeding (eTRF) and Alternate Day Fasting (ADF).

Despite differences in dietary acceptability, there were no significant differences in weight loss or energy intake among the three fasting protocols, indicating that adherence may be more influenced by personal preference than by the specific diet's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. Turner-McGrievy, GM., Wirth, MD., Bernhart, JA., et al.[2022]

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]

Time-restricted eating (TRE) has shown promising therapeutic effects in rodent studies, particularly in relation to body weight and metabolic health, but results in humans are inconsistent due to varying study designs and populations.

This review highlights the need for more standardized research on TRE in humans to better understand its effects and interactions with circadian biology, as well as to identify gaps in current knowledge for future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex physiology and clinical implications of time-restricted eating. Petersen, MC., Gallop, MR., Flores Ramos, S., et al.[2023]

Time-restricted eating (TRE) shows potential for lowering blood pressure in adults with metabolic syndrome, particularly when meals are consumed earlier in the day and within narrower eating windows.

Current studies on TRE and blood pressure outcomes are limited and inconsistent, highlighting the need for more research to explore the effects of TRE on blood pressure variability throughout the day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. Duan, D., Bhat, S., Jun, JC., et al.[2023]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Bibliometric and visual analysis of time-restricted eating. [2022]

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

Early time-restricted eating affects weight, metabolic health, mood, and sleep in adherent completers: A secondary analysis. [2023]

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

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

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

Time restricted eating as a weight loss intervention in adults with obesity. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Current research: effect of time restricted eating on weight and cardiometabolic health. [2022]

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

Will Delaying Breakfast Mitigate the Metabolic Health Benefits of Time-Restricted Eating? [2021]

7. England pubmed.ncbi.nlm.nih.gov

The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. [2022]

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]

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

Complex physiology and clinical implications of time-restricted eating. [2023]

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

Time-Restricted Eating in Metabolic Syndrome-Focus on Blood Pressure Outcomes. [2023]

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

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