Effectiveness of Low-Calorie MIND-HK Diet and Very Low-Calorie Diet on Glycemic Control and Cardiovascular Outcomes in Adults With Type 2 Diabetes: A 12-Week Randomized Controlled Trial

This study addresses the critical clinical need to optimize dietary interventions for Chinese adults managing Type 2 Diabetes Mellitus (T2DM). While calorie restriction is widely known to aid in diabetes management, there is limited evidence comparing the distinct efficacy and physiological safety profiles of a standard low-calorie diet versus an intensive, very low-calorie approach when adapted to local dietary preferences. By evaluating the tailored MIND-HK diet, this trial aims to establish an effective, practical framework for improving long-term glycemic control and reducing cardiovascular risks.

To achieve robust and reliable results, the study uses a rigorous 12-week, parallel-group Randomized Controlled Trial (RCT) design involving 180 participants divided equally into three arms. The structure combines intensive, professional in-person coaching from a registered nutritionist with continuous remote support via WhatsApp to maximize participant adherence and behavioral retention. Furthermore, the integration of the Bluetooth-connected KetoMetrics Breath Ketone System provides a critical safety buffer, allowing real-time tracking of calorie intake and early detection of ketosis to prevent complications like diabetic ketoacidosis (DKA). By standardizing the contact time across all arms-including an attention control group receiving infectious disease health education-the trial minimizes bias and ensures that any observed improvements in HbA1c, fasting glucose, lipid profiles, and blood pressure are directly attributable to the nutritional interventions.

Inclusion criteria

• aged 40 to 70 years old;
• diagnosed with Type II DM; and
• Chinese ethnicity and able to speak and understand Cantonese.

Exclusion criteria

• patients on dialysis;
• Type I and Type II DM patients with insulin use;
• allergic to more than one type of food in the Low-calorie MIND-HK diet and very Low-calorie MIND- HK diet (e.g. nuts, berries, olive oil, or fish);
• Pregnant or Breastfeeding Women;
• Individuals with severe mental health conditions including severe depression, anxiety or other mental issues may struggle with the psychological demands of a very low calorie diet;
• People with low BMI less than 18.5;
• participation ni any dietary program within the past 3 months.