Effectiveness of Low-Calorie MIND-HK Diet and Very Low-Calorie Diet on Glycemic Control and Cardi… (NCT07635121) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
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
180 participantsStarted 2026-07-01
Plain-language summary
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.
Who can participate
Age range
40 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compares a low-calorie MIND-HK diet against a very low-calorie diet for people with Type 2 diabetes — can you help me understand how these two approaches differ, and which one might be more realistic for my current eating habits and health situation?
2The trial is listed as 'not yet recruiting,' so if I'm interested, how long might I realistically have to wait before I could even be considered, and should I be pursuing other treatment options in the meantime?
3Since this is a 12-week study measuring HbA1c as the main outcome, does my current HbA1c level suggest I have enough room for improvement that a dietary intervention trial like this could be meaningful for me, or would I be better served by adjusting my current medications first?
4The trial is Phase NA, meaning it may be more about comparing dietary strategies than establishing safety — are there any risks specific to very low-calorie dieting I should be aware of given my personal health history, such as hypoglycemia risk if I'm on insulin or other glucose-lowering medications?
5Beyond blood sugar control, this trial also tracks cardiovascular outcomes — given my own cardiovascular risk factors, is this the kind of study where the measurements being taken would actually give my care team useful information about my health, even if I ended up in either diet group?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.