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

Starting soon · Not applicable

Conditions studied: Diabetes Mellitus Type 2

In brief

The objective of this project is to assess the effectiveness of a low-calorie and very low-calorie Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND-HK) diet in improving glycemic control and cardiovascular outcomes in adults with T2DM. A total of 180 participants aged 40 to 70, diagnosed with T2DM, will be recruited and randomized into three groups: intervention 1 following the low-calorie MIND-HK diet, intervention 2 following the very low-calorie diet, and an attention control group. The two intervention groups will attend four in-person nutrition counseling sessions (one per week, 60 minutes per session, followed by a 30-minute Q\&A) at a community centre and will use KetoMetrics Breath Ketone System and dietary mobile app, to track diet and monitor daily ketone levels for early signs of ketosis that may lead to diabetic ketoacidosis (DKA). The attention control group will receive an equal amount of attention through four in-person infectious disease counseling sessions. The primary outcome will be HbA1c levels. Secondary outcomes include fasting blood glucose, lipid profile, blood pressure, body mass index, waist circumference, breath ketone, scores from the Summary Diabetes Self-Care Activities (SDSCA) Questionnaire, and MIND diet scores. This study will contribute to the growing body of evidence on dietary interventions for managing T2DM in adults.

Key facts

Study ID

NCT07635121

Run by

Hong Kong Metropolitan University

People needed

180

Starts

2026-07-01

Expected to finish

2029-01-31

Last updated by the study team

2026-07-31

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

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