Time Restricted Eating for Type 2 Diabetes
(SFS3 Trial)
Recruiting in Palo Alto (17 mi)
Overseen byLisa Chow, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Minnesota
Must be taking: Metformin
Must not be taking: Other diabetes medications
Disqualifiers: Pregnancy, Eating disorders, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients \[BMI:25-35 kg/m2\] with metformin-only treated Type 2 diabetes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it requires that participants are only treated with metformin for their type 2 diabetes.
What data supports the effectiveness of the treatment Time Restricted Eating for Type 2 Diabetes?
Research shows that time-restricted eating can improve blood sugar control and insulin sensitivity in people with type 2 diabetes. Studies also suggest that this approach can lead to better glucose tolerance compared to standard calorie restriction, although some benefits may diminish over time.
12345Is time-restricted eating safe for humans?
Research suggests that time-restricted eating, which involves eating within a specific time window each day, is generally safe for humans. Studies have shown that it can be safely practiced by adults with obesity and those at risk of type 2 diabetes, with only mild and temporary side effects like fatigue, constipation, and headache reported.
12567How is time-restricted eating different from other treatments for type 2 diabetes?
Time-restricted eating is unique because it focuses on limiting the hours during which food is consumed each day, rather than just reducing calorie intake. This approach can improve blood sugar control and insulin sensitivity by aligning eating patterns with the body's natural circadian rhythms, which is different from traditional calorie restriction or medication-based treatments.
12589Eligibility Criteria
This trial is for adults aged 18-65 with Type 2 diabetes treated only with metformin, having a BMI of 25-40 and stable weight. Participants should have an HbA1c level between 6.5-8.5% and own a smartphone. Pregnant individuals, those on other diabetes medications besides metformin, or with eating disorders cannot join.Inclusion Criteria
Self-reported weight must be stable [±5 pounds] for at least 3 months prior to the study
Your HbA1c level is between 6.5% and 8.5%.
I am overweight and have type 2 diabetes treated only with metformin.
+4 more
Exclusion Criteria
Active or anticipated pregnancy during the study
I am being treated for Type 2 diabetes with medication other than metformin.
You have an eating disorder, as indicated by a survey.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo a 24-week feasibility study to test time restricted eating (TRE) as an alternative to caloric restriction
24 weeks
Regular visits for monitoring and data collection
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing if time restricted eating (TRE), where participants eat during a fixed daily window without calorie counting, can improve blood sugar levels compared to traditional caloric restriction over a period of 24 weeks in overweight/obese patients.
2Treatment groups
Experimental Treatment
Active Control
Group I: Time restricted eatingExperimental Treatment1 Intervention
daily 8 hour eating window
Group II: Caloric RestrictionActive Control1 Intervention
reduction of caloric intake by 15%
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of MinnesotaMinneapolis, MN
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Who Is Running the Clinical Trial?
University of MinnesotaLead Sponsor
References
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.
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 .
Evidence-based information about intermittent fasting in diabetes patients: useful or harmful? [2023]One of the most important components of treatment for diabetic patients is diet and healthy nutrition therapy. Calorie restriction is effective and without cost increases its appeal for both patients and physicians. Unfortunately, continuous calorie restriction is a difficult method. For this reason, alternative calorie restriction methods, such as intermittent fasting (IF), have been investigated by some researchers.
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).
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.
Safety of 8-h time restricted feeding in adults with obesity. [2019]This study examines the safety of time restricted feeding (TRF; 8-h feeding window/16-h fasting window daily) in obese adults. Twenty-three subjects participated in an 8-h TRF intervention for 12 weeks. Self-reported adverse events, body image perception, complete blood count, and disordered eating patterns did not change from baseline to week 12. These findings suggest that consuming food within an 8-h window can safely facilitate weight loss in subjects with obesity.
Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. [2023]Time-restricted eating (TRE) has become increasingly popular, yet longer-term randomized clinical trials have not evaluated its efficacy and safety in patients with type 2 diabetes (T2D).
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.
Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study. [2022]Time restricted feeding is a form of intermittent fasting where participants shorten the daily window in which they eat.