Meal Timing for Type 2 Diabetes
(TimeLEAD Trial)
Recruiting in Palo Alto (17 mi)
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Children's Hospital Los Angeles
Must not be taking: Anti-obesity, Diabetes medications
Disqualifiers: Prader-Willi, Brain tumor, Eating disorder, others
No Placebo Group
Trial Summary
What is the purpose of this trial?To find the effectiveness of a diet plan (Time Limited Eating or TLE) on glycemic control, B-cell function, body fat, and body mass index (BMI) in adolescents with type 2 diabetes.
Will I have to stop taking my current medications?
The trial requires that participants do not have any planned use of anti-obesity or other diabetes medications. If you are currently taking such medications, you may need to stop them to participate.
What data supports the effectiveness of the treatment Continuous Glucose Monitor, CGM, Continuous Glucose Sensor, Glucose Monitoring System, Control, Placebo, Standard Care, Time Limited Eating, Time-Restricted Eating, TRE, Intermittent Fasting, 16:8 Eating Pattern, Leangains Diet for Type 2 Diabetes?
Research shows that time-restricted eating (TRE), a form of intermittent fasting, can improve blood sugar control in people with type 2 diabetes by limiting eating to a specific time window each day. Studies found that TRE can help manage daily blood sugar levels and improve glucose tolerance, especially when combined with early meal timing.
12345Is time-restricted eating safe for people with type 2 diabetes?
Time-restricted eating (TRE) appears to be generally safe for people with type 2 diabetes, with studies showing it is feasible and achievable. Some participants reported mild side effects like fatigue, constipation, and headaches, but these were transient.
12345How does time-restricted eating differ from other treatments for type 2 diabetes?
Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which food is consumed each day, rather than restricting calories or specific foods. This approach can improve blood sugar control and weight management by aligning eating patterns with the body's natural circadian rhythms, which is different from traditional methods like continuous calorie restriction or medication.
12456Eligibility Criteria
Adolescents aged 12-21 with Type 2 Diabetes (T2D) and a Hemoglobin A1c below 9% can join this trial. They must be at least in Tanner stage III of puberty, able to follow the study's schedule, and not have any eating disorders or conditions like Prader-Willi Syndrome.Inclusion Criteria
Participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods
Your blood sugar level (Hemoglobin A1c) is less than 9%.
I have been diagnosed with Type 2 Diabetes.
+2 more
Exclusion Criteria
I have had an eating disorder or symptoms of one.
I have been diagnosed with Prader-Willi Syndrome, a brain tumor, or hypothalamic obesity.
You are currently taking part in another program to lose weight.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
1 visit (in-person or virtual)
Baseline Assessment
Participants and families complete baseline surveys and receive training on CGM use
1 week
1 visit (in-person)
Treatment
Participants follow either a Time Limited Eating schedule or a Control eating schedule for 12 weeks
12 weeks
Weekly phone encounters
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person or virtual)
Participant Groups
The trial is testing Time Limited Eating (TLE), where participants eat within an 8-hour window and fast for 16 hours daily, against a control group with a regular eating period over 12 hours. The goal is to see if TLE improves blood sugar control and body composition in adolescents with T2D.
2Treatment groups
Experimental Treatment
Group I: Time Limited EatingExperimental Treatment3 Interventions
Time Limited Eating: 8-hour eating period (16 hours of daily fasting).
Group II: Control: 12 hour eating periodExperimental Treatment3 Interventions
Control: Habitual daily eating period (no meal time restrictions)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Children's Hospital of Los AngelesLos Angeles, CA
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Who Is Running the Clinical Trial?
Children's Hospital Los AngelesLead Sponsor
References
Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. [2023]To design an appealing time-restricted eating (TRE) intervention by exploring behavioral and social mechanisms to improve TRE adoption and maintenance among people with type 2 diabetes (T2D) and overweight. Time-restricted eating is an intermittent fasting regimen suggested to improve glycemic control and body weight.
Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial. [2021]Time-restricted feeding is an emerging dietary intervention that is becoming increasingly popular. There are, however, no randomised clinical trials of time-restricted feeding in overweight patients with type 2 diabetes. Here, we explored the effects of time-restricted feeding on glycaemic regulation and weight changes in overweight patients with type 2 diabetes over 12 weeks.
Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. [2022]Individuals with type 2 diabetes (T2D) require a long-term dietary strategy for blood glucose management and may benefit from time-restricted eating (TRE, where the duration between the first and last energy intake is restricted to 8-10 h/day). We aimed to determine the feasibility of TRE for individuals with T2D. Participants with T2D (HbA1c >6.5 to <9%, eating window >12 h/day) were recruited to a pre-post, non-randomised intervention consisting of a 2-week Habitual period to establish baseline dietary intake, followed by a 4-weeks TRE intervention during which they were instructed to limit all eating occasions to between 10:00 and 19:00 h on as many days of each week as possible. Recruitment, retention, acceptability, and safety were recorded throughout the study as indicators of feasibility. Dietary intake, glycaemic control, psychological well-being, acceptability, cognitive outcomes, and physiological measures were explored as secondary outcomes. From 594 interested persons, and 27 eligible individuals, 24 participants enrolled and 19 participants (mean ± SD; age: 50 ± 9 years, BMI: 34 ± 5 kg/m2, HbA1c: 7.6 ± 1.1%) completed the 6-week study. Overall daily dietary intake did not change between Habitual (~8400 kJ/d; 35% carbohydrate, 20% protein, 41% fat, 1% alcohol) and TRE periods (~8500 kJ/d; 35% carbohydrate, 19% protein, 42% fat, 1% alcohol). Compliance to the 9 h TRE period was 72 ± 24% of 28 days (i.e., ~5 days/week), with varied adherence (range: 4-100%). Comparisons of adherent vs. non-adherent TRE days showed that adherence to the 9-h TRE window reduced daily energy intake through lower absolute carbohydrate and alcohol intakes. Overall, TRE did not significantly improve measures of glycaemic control (HbA1c -0.2 ± 0.4%; p = 0.053) or reduce body mass. TRE did not impair or improve psychological well-being, with variable effects on cognitive function. Participants described hunger, daily stressors, and emotions as the main barriers to adherence. We demonstrate that 4-weeks of TRE is feasible and achievable for these individuals with T2D to adhere to for at least 5 days/week. The degree of adherence to TRE strongly influenced daily energy intake. Future trials may benefit from supporting participants to incorporate TRE in regular daily life and to overcome barriers to adherence.
Intermittent fasting plus early time-restricted eating versus calorie restriction and standard care in adults at risk of type 2 diabetes: a randomized controlled trial. [2023]Intermittent fasting appears an equivalent alternative to calorie restriction (CR) to improve health in humans. However, few trials have considered applying meal timing during the 'fasting' day, which may be a limitation. We developed a novel intermittent fasting plus early time-restricted eating (iTRE) approach. Adults (N = 209, 58 ± 10 years, 34.8 ± 4.7 kg m-2) at increased risk of developing type 2 diabetes were randomized to one of three groups (2:2:1): iTRE (30% energy requirements between 0800 and 1200 hours and followed by a 20-h fasting period on three nonconsecutive days per week, and ad libitum eating on other days); CR (70% of energy requirements daily, without time prescription); or standard care (weight loss booklet). This open-label, parallel group, three-arm randomized controlled trial provided nutritional support to participants in the iTRE and CR arms for 6 months, with an additional 12-month follow-up. The primary outcome was change in glucose area under the curve in response to a mixed-meal tolerance test at month 6 in iTRE versus CR. Glucose tolerance was improved to a greater extent in iTRE compared with CR (-10.10 (95% confidence interval -14.08, -6.11) versus -3.57 (95% confidence interval -7.72, 0.57) mg dl-1 min-1; P = 0.03) at month 6, but these differences were lost at month 18. Adverse events were transient and generally mild. Reports of fatigue were higher in iTRE versus CR and standard care, whereas reports of constipation and headache were higher in iTRE and CR versus standard care. In conclusion, incorporating advice for meal timing with prolonged fasting led to greater improvements in postprandial glucose metabolism in adults at increased risk of developing type 2 diabetes. ClinicalTrials.gov identifier NCT03689608 .
Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. [2023]Examine the effect of 5 d/wk, 9-h time-restricted eating (TRE) protocol on 24-h glycaemic control in adults with type 2 diabetes (T2D).
Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. [2022]In type 2 diabetes, insulin resistance and progressive β-cell failure require treatment with high insulin doses, leading to weight gain. Our aim was to study whether a three-meal diet (3Mdiet) with a carbohydrate-rich breakfast may upregulate clock gene expression and, as a result, allow dose reduction of insulin, leading to weight loss and better glycemic control compared with an isocaloric six-meal diet (6Mdiet).