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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether changing meal timing can help control blood sugar and improve heart health in people with prediabetes. Participants will eat all meals within specific time windows each day: some will eat early (Early Time-Restricted Feeding), others mid-day (Mid-day Time-Restricted Feeding), and some will follow a typical schedule (Control Schedule). The study aims to determine if time-restricted eating can lower the risk of developing type 2 diabetes and improve health markers like blood pressure. It suits those who are prediabetic, have a regular wake-up time between 5 and 8 a.m., and are open to following a set eating schedule. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on meal timing and 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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that time-restricted eating (TRE), where eating occurs only during a short period each day, has mixed safety results. Some studies highlight benefits such as better metabolism, weight loss, and improved blood sugar levels. These studies suggest that TRE is generally safe and well-tolerated, with few negative effects reported.

However, other research indicates possible risks. One study observed that eating all meals within an 8-hour window might increase the risk of dying from heart-related issues by 91%. This suggests that while TRE might help with some health aspects, it could also pose significant risks, especially for heart health.

Overall, considering both the potential benefits and risks of TRE is important. Participants should consult their healthcare providers about any concerns before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring time-restricted feeding (TRE) as a strategy for addressing cardiovascular disease risk factors. Unlike typical treatments that rely on medications to manage blood pressure and cholesterol levels, TRE focuses on when you eat rather than what you eat, potentially offering a natural and non-pharmacological option. The Early TRE and Mid-day TRE approaches allow individuals to eat within specific time windows, which may help improve metabolic health by aligning eating patterns with the body's natural circadian rhythms. This method could lead to better heart health with fewer side effects, offering an innovative alternative to traditional pharmaceutical approaches.

What evidence suggests that this trial's treatments could be effective for cardiovascular disease risk factors?

This trial will compare different time-restricted eating (TRE) schedules to assess their impact on cardiovascular disease risk factors. Participants will be assigned to one of the following arms: Early Time-Restricted Eating (eTRE), Mid-day Time-Restricted Eating, or a Control Schedule. Research has shown that TRE, which involves eating only during certain hours of the day, can improve health markers related to heart disease. Specifically, early time-restricted eating (eTRE), where eating occurs earlier in the day, has helped with weight loss and lowered blood pressure, especially compared to eating throughout the day. Studies suggest that eTRE is more effective than a regular eating schedule for improving heart health. Mid-day TRE has shown promise in helping people with obesity lose 1–4% of their body weight. However, some studies have raised concerns about possible risks, such as an increased chance of heart issues with certain TRE schedules. Overall, TRE shows potential benefits for heart health, but it's important to consider all available research. ^{1 6 7 8 9}

Who Is on the Research Team?

Courtney Peterson, Ph.D.

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

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.

Pregnant or breastfeeding

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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), 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]

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]

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) 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) 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) 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]

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]

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]

Citations

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8-hour time-restricted eating linked to a 91% higher risk of ... 8-hour time-restricted eating linked to a 91% higher risk of cardiovascular death · The study included approximately 20,000 adults in the U.S. ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12289860/

Intermittent Fasting for the Prevention of Cardiovascular ... Modified alternate-day fasting, and time-restricted eating appear to be promising approaches for reducing most cardiovascular risk factors.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35939311/

Effectiveness of Early Time-Restricted Eating for Weight Loss ... In this randomized clinical trial, eTRE was more effective for losing weight and improving diastolic blood pressure and mood than eating over a window of 12 or ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666379123005803

Early time-restricted eating improves markers of ... The eTRE schedule is more effective than the control eating schedule for improving markers of cardiometabolic health, including 24-h mean ...

5. insight.jci.org insight.jci.org/articles/view/160257

Time-restricted feeding reduces cardiovascular disease ... The results indicate that 2 weeks of TRF in a mouse model of established HFD-induced obesity is sufficient to reduce cardiovascular disease risk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8218778/

Time-Restricted Eating to Improve Cardiovascular Health The purpose of this review is to summarize the current literature pertaining to the effects of TRE on body weight and cardiovascular disease risk factors.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0011502924001044

Intermittent fasting and cardiovascular disease: A scoping ... A recent observational study indicates a 91 % increased risk of CVD mortality associated with IF compared to consuming meals throughout a 12- to 16-hour period.

8. onlinecjc.ca onlinecjc.ca/article/S0828-282X(23)01731-2/fulltext

Time-Restricted Eating: A Novel Dietary Strategy for ... In subgroup analyses of patients with no heart failure history (n = 1472), routine fasting was associated with 69% reduced risk of heart failure ...

9. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2025.1524125/full

A perspective on intermittent fasting and cardiovascular ... Intermittent fasting has been linked to metabolic health by improving lipid profiles, reducing body weight, and increasing insulin sensitivity.