Rationale and protocol for a randomized parallel intervention trial of two intermittent fasting approaches in...

Area of Science:

• Endocrinology and Metabolism
• Nutritional Science
• Diabetes Research

Background:

• Type 2 diabetes (T2D) involves insulin resistance and beta-cell dysfunction, often worsened by obesity.
• Intermittent fasting (IF) methods like intermittent energy restriction (IER) and time-restricted eating (TRE) show potential for improving glycemic control and diabetes remission.
• The comparative effectiveness and feasibility of IER versus TRE in T2D patients are not well-established.

Purpose of the Study:

• To compare the feasibility, acceptability, and metabolic outcomes of IER and TRE in adults with T2D.
• To evaluate changes in glycemic control, insulin sensitivity, and body composition.
• To identify predictors of response to different IF strategies.

Main Methods:

• A randomized parallel trial involving 56 adults with T2D and overweight/obesity.
• Intervention groups: IER (specific calorie restriction on 2-3 days/week) or TRE (8-hour daily eating window).
• Both groups received remote diabetes education and behavioral support for 6 months, followed by self-managed continuation.

Main Results:

• Primary outcomes assessed feasibility (recruitment, retention, adherence) and acceptability.
• Secondary outcomes included changes in HbA1c, insulin sensitivity, insulin response, body composition, and diabetes remission rates.
• Continuous glucose monitoring and metabolic phenotyping were used to identify response predictors.

Conclusions:

• This is the first parallel trial directly comparing IER and TRE in T2D patients with overweight/obesity.
• The study will yield crucial data on metabolic and behavioral responses to IER and TRE.
• Findings will inform personalized nutrition therapy strategies for managing T2D.