Time-Restricted Eating for Type 2 Diabetes

Overseen By Amy A Kirkham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Toronto

Must not be taking: Exogenous insulin, Sulfonylureas, Antiobesity medications

Disqualifiers: Bariatric surgery, Cognitive disorder, others

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

Compensation: Varies

Number of Visits: 4

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effects of time-restricted eating (TRE) on blood sugar control in individuals who are obese and either have or are at risk for type 2 diabetes. Participants will consume all meals within one of three different 9-hour windows—Early (7:00 - 16:00), Late (12:00 - 21:00), or Mid (9:30 - 18:30)—to determine if meal timing affects outcomes. Suitable candidates should have a body mass index over 30, have or be at risk for type 2 diabetes, and own a smartphone with Bluetooth. As an unphased trial, this study provides an opportunity to contribute to groundbreaking research on meal timing and its impact on health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking more than three diabetes medications, insulin, or sulfonylureas, you cannot participate. It seems you can continue other medications, but it's best to confirm with the trial coordinators.

What prior data suggests that time-restricted eating is safe for individuals with type 2 diabetes?

Research shows that time-restricted eating (TRE) is generally safe for people with type 2 diabetes or those at risk. Studies have found that TRE can aid weight loss and improve insulin use. Participants in these studies did not report major side effects, indicating that TRE is well-tolerated.

For early TRE, studies have shown improvements in blood sugar control and weight loss without significant negative effects. Similarly, late TRE has been linked to lower blood sugar levels and better insulin use, with no reported cases of low blood sugar. Mid TRE also appears safe and effective for weight loss and reducing blood sugar levels.

Overall, TRE seems to be a safe option for managing type 2 diabetes, with research supporting its benefits and minimal reported side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about time-restricted eating (TRE) for type 2 diabetes because it offers a novel approach by focusing on when we eat rather than just what we eat. Unlike conventional treatments like medications and dietary changes that target blood sugar levels and weight loss, TRE aims to optimize the body's natural rhythms and improve metabolic health by concentrating food intake within specific time windows. The study examines three different TRE schedules—early, mid, and late—each potentially suiting different lifestyles and body clocks. This method could provide a flexible, non-pharmaceutical option that may enhance blood sugar control and overall health in a way that is easy for people to implement in their daily lives.

What evidence suggests that this trial's time-restricted eating treatments could be effective for type 2 diabetes?

Research shows that time-restricted eating (TRE) can help manage type 2 diabetes and related health issues. This trial will compare different TRE schedules. Participants in the Early TRE arm will eat between 7:00 AM and 4:00 PM. Evidence suggests this schedule can improve how the body handles sugar and uses insulin. Those in the Late TRE arm will eat between 12:00 PM and 9:00 PM, which has been linked to better blood sugar control and weight loss. Participants in the Mid TRE arm will eat between 9:30 AM and 6:30 PM, showing promise for weight loss and better blood sugar management. Overall, these studies suggest that TRE could effectively improve health for those at risk of or managing type 2 diabetes. ^{2 3 6 7 8}

Who Is on the Research Team?

Amy A Kirkham, PhD

Principal Investigator

University of Toronto

Are You a Good Fit for This Trial?

This trial is for adults over 18 with obesity (BMI >30 and <50) who have type 2 diabetes or are at high risk for it. Participants must own a smartphone with Bluetooth. Exclusions include those on extensive diabetes treatments, recent medication changes, very high A1c levels, using insulin or certain drugs, significant recent weight loss, planned bariatric surgery, cognitive disorders affecting consent ability, eating disorders or unwillingness to adjust eating times.

Inclusion Criteria

I am older than 18 years.

I have type 2 diabetes or am at high risk for it.

Your body mass index is between 30 and 50.

Exclusion Criteria

I have lost more than 5% of my weight in the last 3 months.

My body weight is over 340lbs.

I have had or am referred for weight-loss surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Control

Participants eat as they normally do without any changes to their eating schedule

1 week

1 visit (in-person)

Early TRE

Participants eat ad libitum between 7:00 - 16:00 each day for seven days, followed by a meal replacement on the 8th day

1 week

1 visit (in-person)

Mid TRE

Participants eat ad libitum between 9:30 - 18:30 each day for seven days, followed by a meal replacement on the 8th day

1 week

1 visit (in-person)

Late TRE

Participants eat ad libitum between 12:00 - 21:00 each day for seven days, followed by a meal replacement on the 8th day

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Early (7:00 - 16:00) TRE
• Late (12:00 - 21:00) TRE
• Mid (9:30 - 18:30) TRE

Trial Overview The study tests the impact of time-restricted eating (TRE) on blood sugar control in obese individuals with or at risk for type 2 diabetes. It compares three different TRE schedules: early (7am-4pm), midday (9:30am-6:30pm), and late (12pm-9pm). The goal is to see if the timing affects glycemic control differently between men and women.

How Is the Trial Designed?

Group I: Mid (9:30-18:30h) TRE Experimental Treatment 1 Intervention

Participants will be asked to eat ad libitum between the hours of 9:30 - 18:30 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 9:30 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.

Group II: Late (12:00-21:00h) TRE Experimental Treatment 1 Intervention

Participants will be asked to eat ad libitum between the hours of 12:00 - 21:00 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 12:00 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.

Group III: Early (7:00-16:00h) TRE Experimental Treatment 1 Intervention

Participants will be asked to eat ad libitum between the hours of 7:00 - 16:00 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 7:00 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.

Group IV: Control Active Control 1 Intervention

During the first week of the study, participants will be asked to eat as they normally do, and to not make any changes regarding when they are stopping or starting eating.

Who Is Running the Clinical Trial?

University of Toronto

Lead Sponsor

Trials

739

Recruited

1,125,000+

Wharton Medical Clinic

Collaborator

Trials

2

Recruited

170+

Diabetes Canada

Collaborator

Trials

13

Recruited

1,200+

Published Research Related to This Trial

In a 6-month randomized clinical trial with 75 participants who had type 2 diabetes, time-restricted eating (TRE) led to a significant weight loss of 3.56% compared to controls, while daily calorie restriction (CR) did not show a significant difference in weight loss.

Both TRE and CR resulted in similar reductions in hemoglobin A1c (HbA1c) levels, indicating that TRE can be an effective dietary strategy for improving glycemic control without the need for calorie counting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. Pavlou, V., Cienfuegos, S., Lin, S., et al.[2023]

In a 12-week study involving 120 overweight adults with type 2 diabetes, time-restricted feeding (10-hour eating window) significantly improved glycaemic control, as evidenced by a 1.54% reduction in HbA1c and a weight loss of nearly 3 kg compared to a control group.

Participants in the time-restricted feeding group also showed improved insulin sensitivity and reduced levels of triglycerides and cholesterol, suggesting additional cardiovascular benefits alongside better diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial. Che, T., Yan, C., Tian, D., et al.[2021]

A 4-week, 9-hour time-restricted eating (TRE) protocol significantly improved glycaemic control in 19 adults with type 2 diabetes, reducing mean 24-hour glucose concentrations and total area under the curve (AUC) without changing dietary intake or physical activity levels.

Participants experienced 10% more time in the target glucose range and 10% less time above the target range during the TRE period, indicating enhanced blood sugar management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. Parr, EB., Steventon-Lorenzen, N., Johnston, R., et al.[2023]

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]

The RESET study is a randomized controlled trial involving 100 participants at high risk for type 2 diabetes, investigating the effects of time-restricted eating (TRE) on body weight and metabolic health over a 3-month intervention period.

The primary outcome is the change in body weight after 3 months, with secondary outcomes including various metabolic and behavioral measures, aiming to determine the effectiveness and feasibility of TRE for improving health in individuals with overweight or obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a single-centre, parallel-group, randomised, controlled, superiority trial on the effects of time-restricted eating on body weight, behaviour and metabolism in individuals at high risk of type 2 diabetes: the REStricted Eating Time (RESET) study. Quist, JS., Jensen, MM., Clemmensen, KKB., et al.[2022]

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.

Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]

Time-restricted eating (TRE) appears to be safe for individuals with type 2 diabetes, based on four completed studies and 14 ongoing studies, provided that their antidiabetic medications are monitored and adjusted accordingly.

Despite the promising safety profile of TRE, the limited number of studies and their low generalizability highlight the need for further research to establish clear recommendations for its efficacy and safety in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Time-Restricted Eating Safe in the Treatment of Type 2 Diabetes?-A Review of Intervention Studies. Uldal, S., Clemmensen, KKB., Persson, F., et al.[2022]

The early time-restricted carbohydrate consumption (eTRC) diet was found to be a feasible and effective alternative for managing glucose levels and body weight in individuals with type 2 diabetes, with similar outcomes to a Mediterranean-style control diet over 12 weeks.

Both the eTRC and control diets resulted in comparable reductions in HbA1c and body weight, indicating that while eTRC is a viable dietary strategy, it does not provide additional metabolic benefits compared to conventional dieting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. Tricò, D., Masoni, MC., Baldi, S., et al.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S026156142500216X

Effects of time-restricted eating on glycemic control in type ... Human studies demonstrate that TRE helps to reduce body weight and fat mass, improve glucose tolerance and lower blood pressure in individuals with overweight ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10804344/

The effects of early time restricted eating plus daily caloric ... Emerging literature suggests that time restricted eating (TRE) may improve glucose tolerance and insulin sensitivity.

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811116

Effect of Time-Restricted Eating on Weight Loss in Adults ... In a 6-month randomized clinical trial involving 75 adults with T2D, TRE was more effective for weight loss (−3.6%) than CR (−1.8%) compared with controls.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03940482

Time Restricted Eating As Treatment (TREAT) for Diabetes ... It has numerous clinical sequelae including macrovascular and microvascular disease. Nutritional therapy has been widely accepted as being safe and affordable ...

5. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2022.1025919/full

Time-restricted eating for patients with diabetes and ... The results demonstrated that 10-h TRE was an effective, safe and feasible method to improve glucose homeostasis but not insulin sensitivity ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9182892/

Is Time-Restricted Eating Safe in the Treatment of Type 2 ... Recent studies have shown that TRE can lead to weight loss and improvement of insulin sensitivity and glucose tolerance in people with overweight and high risk ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9671354/

Time-restricted eating for patients with diabetes and ... Time-restricted eating is a safe and feasible intervention, and may offer cardiovascular and metabolic benefits for patients with diabetes and prediabetes.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06887543

The Impact of Time Restricted Eating on Type 2 Diabetes The rationale for this study is that early time-restricted eating (eTRE) has been shown to improve glycemic variation in a weight-neutral setting within 48 ...