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| Name | Class |
|---|---|
| Diabetes Canada | OTHER |
| Wharton Medical Clinic | UNKNOWN |
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This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.
The overarching aim of this study is to evaluate the interactions between TRE window timing, type 2 diabetes status, and sex among individuals with obesity. The first objective is to compare the effects of three 9-h TRE window times (early: 7:00-16:00 h, mid: 9:30-18:30 h, delayed: 12:00-21:00 h) on real-time, free-living glycemic control. The second objective is to determine if type 2 diabetes status (type 2 diabetes versus prediabetes or moderate+ risk for type 2 diabetes aka at risk for type 2 diabetes) modifies the effect of eating window timing on glycemic control outcomes. The exploratory objectives include: 1) determine whether sex modifies TRE adherence or the effect of TRE on metabolic changes relative to control; and 2) to compare changes in dietary intake, body weight, and blood pressure within and between early, mid, and delayed TRE. We have the following hypotheses related to these objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early (7:00-16:00h) TRE | Experimental | 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. |
|
| Mid (9:30-18:30h) TRE | Experimental | 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. |
|
| Late (12:00-21:00h) TRE | Experimental | 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. |
|
| Control | No 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early (7:00 - 16:00) TRE | Behavioral | A standardized TRE Protocol where participants eat ad libitum between the hours of 7:00 to 16:00 for 7 days. On the 8th day, they will consume a meal replacement beverage at 7:00, and not consume anything else for two hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Average 24-hour glucose total area under the curve (AUC) over 7 days | Assessed for 7 continuous days using a continuous glucose monitor. | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Average 24-hour glucose over 7 days | Assessed for 7 continuous days using a continuous glucose monitor. | 7 days |
| Average daily nocturnal glucose over 7 evenings | Assessed for 7 continuous evenings based on the sleep period identified by the Fitbit tracker using a continuous glucose monitor. |
| Measure | Description | Time Frame |
|---|---|---|
| Dietary intake | Participants will complete the ASA-24 at baseline, and during each of the intervention periods to assess changes in macro and micronutrient composition of their diet. | 7 days |
| Weight change |
Inclusion Criteria:
Exclusion Criteria:
Individuals with type 2 diabetes will be excluded if: (1) currently on >2 monotherapies for diabetes, (2) have had diabetes therapy medication or dosage changes <3 months, (3) self-reported hemoglobin A1c >9.0%, (4) taking exogenous insulin, or (5) taking sulfonylureas
The following exclusion criteria applies to all potential participants:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amy A Kirkham, PhD | Contact | 416-946-4069 | amy.kirkham@utoronto.ca | |
| Teresita Gormaz Clinical Trial coordinator, MsC | Contact | +1-416-946-0036 | establish.study.kpe@utoronto.ca |
| Name | Affiliation | Role |
|---|---|---|
| Amy A. Kirkham, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Remote Ontario-wide | Recruiting | Toronto | Ontario | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D009765 | Obesity |
| D011236 | Prediabetic State |
| D006943 | Hyperglycemia |
| D000093763 | Intermittent Fasting |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D014198 | Trehalase |
| ID | Term |
|---|---|
| D004186 | Disaccharidases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
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| Mid (9:30 - 18:30) TRE | Behavioral | A standardized TRE Protocol where participants eat ad libitum between the hours of 9:30 to 18:30 for 7 days. On the 8th day, they will consume a meal replacement beverage at 9:30, and not consume anything else for two hours. |
|
| Late (12:00 - 21:00) TRE | Behavioral | A standardized TRE Protocol where participants eat ad libitum between the hours of 12:00 to 21:00 for 7 days. On the 8th day, they will consume a meal replacement beverage at 12:00, and not consume anything else for two hours. |
|
| 7 days |
| Average daily time spent in hyperglycemia over 7 days | The average number of hours with glucose >10 mmol/L over 7 continuous days assessed with a continuous glucose monitor. | 7 days |
| Postprandial glucose | Assessed on the morning after the 7th day of each TRE protocol. Participants will consume a standardized breakfast at a specified time, and glucose will be evaluated via continuous glucose monitor from the time they start consuming the breakfast for 2 hours. | 2 hours |
| Glycemic viability | The average of each standard metrics of glycemic viability (standard deviation, coefficient of variation, mean amplitude of glycemic exercise, and continuous overall net glycemic action) will be calculated over 7 continuous days from continuous glucose monitors. | 7 days |
| Patient acceptability | Patient acceptability will be assessed based on researcher-developed questions related to their experience with each TRE protocol. | 7 days |
| TRE fasting duration adherence | Participants will receive twice daily text messages asking what time they started and stopped eating that day, which will be used to calculate the length of the fast each day. Adherence will be calculated as the % of days where the participant fasted for 15h or longer. | 7 days |
| TRE fasting window adherence | The proportion of days where participants began and ended their meal within 15 min or 30 min of their prescribed time. | 7 days |
Participants will be asked to weigh themselves first thing in the morning, with minimal and no clothing on, after they have emptied their bowels once during the baseline period and on the last day of each of the intervention period.
| 7 days |
| Blood pressure change | Participants will be asked to measure their blood pressure once during the baseline period, and on the last day of each intervention period. | 7 days |
| Physical Activity | Participants will be asked to wear a Fitbit for the duration of the study. We will average the amount of physical activity over 7 days of wear. | 7 days |
| Sleep | Participants will be asked to wear a Fitbit for the duration of the study. We will average the amount of sleep over 7 days of wear. | 7 days |
| Safety and Adverse Events | Participants will be given access to a questionnaire to report any symptoms throughout the intervention. We will compare the proportion of individuals who report these symptoms within each time period. | 7 days |
| D004700 | Endocrine System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005215 | Fasting |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D045762 |
| Enzymes and Coenzymes |