Meal Timing Modification for Type 2 Diabetes

Overseen By Dalia Perelman, MS, RD, CDE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Must be taking: Metformin

Must not be taking: Diabetes medications

Disqualifiers: Major organ disease, Malabsorptive disorders, others

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

Compensation: Varies

Number of Visits: Unknown

75 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of our study is to understand the impact of different meal timing alterations on blood sugars, metabolism, microbiome and sleep physiology in people with prediabetes and diabetes; and to study the temperature/heart rate response to different meals in different people.

Will I have to stop taking my current medications?

If you are taking diabetes medications other than metformin, you will need to stop them to participate in this trial. The protocol does not specify about other medications, so it's best to discuss with the study team.

Is time-restricted eating safe for humans?

The available research does not provide specific safety data for time-restricted eating in humans, but it has been studied in various contexts, including for weight loss and type 2 diabetes management, without reported safety concerns. ^{1 2 3 4 5}

How does meal timing modification differ from other treatments for type 2 diabetes?

Meal timing modification, specifically time-restricted eating, is unique because it focuses on when you eat rather than what you eat. This approach aligns meal times with the body's natural rhythms to improve blood sugar control and insulin sensitivity, which is different from traditional diabetes treatments that often focus on medication or specific dietary restrictions. ^{3 4 6 7 8}

What data supports the effectiveness of the treatment Meal Timing Modification for Type 2 Diabetes?

Research shows that time-restricted eating (TRE), a form of intermittent fasting, can improve blood sugar control and insulin sensitivity in people with type 2 diabetes. Studies have found that TRE can help manage weight and improve daily blood sugar levels, making it a promising approach for managing type 2 diabetes. ^{1 3 4 6 7}

Who Is on the Research Team?

Heyjun Park, PhD

Principal Investigator

Stanford University

Michael Snyder, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with prediabetes or type 2 diabetes managed by diet or metformin. Participants should be generally healthy, not pregnant, and not on weight loss meds or special diets. They must understand the study and agree to its procedures.

Inclusion Criteria

Be willing to provide written informed consent for all study procedures.

Be willing to provide written informed consent for all study procedures

I feel healthy and have no symptoms.

Exclusion Criteria

I am currently using weight loss medications or following a specific diet.

You gained or lost more than 2 kilograms of weight in the last month.

I do not have any major organ disease.

Timeline for a Trial Participant

Baseline

Participants follow their regular dietary intake, physical activity, and sleep while wearing a CGM and an activity monitor. Sleep is monitored for a couple of nights.

20 days

Intervention Phase 1

Participants limit their daily eating to 10 hours or less with a specific eating window and caloric distribution.

20 days

Intervention Phase 2

Participants continue time-restricted eating with a shifted eating window and caloric distribution.

20 days

Intervention Phase 3

Participants continue time-restricted eating with another shift in eating window and caloric distribution.

20 days

Intervention Phase 4

Participants consume provided meals with a determined amount of protein, carbohydrates, and fat. Body temperature and heart rate are monitored.

8 days

Follow-up

Participants are monitored for changes in glycemic control, sleep quality, and heart rate response after the intervention phases.

5 months

What Are the Treatments Tested in This Trial?

Interventions

• Macronutrient-controlled meals
• Time Restrictive Eating- early
• Time Restrictive Eating- early with early caloric intake
• Time Restrictive Eating- late

Trial Overview The study examines how meal timing and composition affect blood sugar levels, metabolism, gut bacteria, body temperature, heart rate response, and sleep in people with prediabetes or type 2 diabetes.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 4 Interventions

Participants will undergo a baseline phase for 20 days, where they will follow their regular dietary intake, physical activity, and sleep. They will be wearing a CGM and an activity monitor and for a couple of nights, they will use a sleep monitor. That will be followed by 4 interventional phases where they will be asked to limit their daily eating to 10 hours or less (Time Restricted Eating, TRE), with the eating window and the caloric distribution will be shifted during each of the next 3 phases, each phase lasting 20 days. The last phase will last 8 days and participants will be asked to consume provided meals with a determined amount of protein, carbohydrates, and fat. Their body temperature will be measured using a continuous temperature device and a heart rate monitor to capture dynamic rage of the sympathetic response during and after the meal consumption (thermotyping).

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

In a study involving 11 sedentary men with overweight/obesity, time-restricted feeding (TRF) for 8 hours per day showed a tendency to lower total 24-hour glucose levels compared to extended feeding (EXF) for 15 hours, with significant improvements in nocturnal glucose control.

Participants reported positive attitudes towards TRF, noting improved well-being, although they identified challenges such as work schedules and social commitments that could hinder adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Delayed Morning and Earlier Evening Time-Restricted Feeding Protocol for Improving Glycemic Control and Dietary Adherence in Men with Overweight/Obesity: A Randomized Controlled Trial. Parr, EB., Devlin, BL., Radford, BE., et al.[2020]

Citations

1. United States 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. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. [2023]

3. England 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. [2021]

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

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

5. Germany pubmed.ncbi.nlm.nih.gov

Early time-restricted carbohydrate consumption vs conventional dieting in type 2 diabetes: a randomised controlled trial. [2023]

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

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. [2023]

7. England 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. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

A Delayed Morning and Earlier Evening Time-Restricted Feeding Protocol for Improving Glycemic Control and Dietary Adherence in Men with Overweight/Obesity: A Randomized Controlled Trial. [2020]