NCT07635121Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- First submitted
- 3 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- 31 Jan 2029
- Lead sponsor
- Hong Kong Metropolitan University
- Diseases
- Type 2 diabetes
- NCT number
- NCT07635121
What you commit to
- Study type: Interventional
- Planned participants: 180
- From 1 Jul 2026 to the primary completion date, 31 Jan 2029
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
- 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;
Other
- patients on dialysis;
- Type I and Type II DM patients with insulin use;
- Pregnant or Breastfeeding Women;
- People with low BMI less than 18.5;
- participation ni any dietary program within the past 3 months.
Who the study is looking for
- aged 40 to 70 years old;
- diagnosed with Type II DM; and
- Chinese ethnicity and able to speak and understand Cantonese.
Age in the registry: 40 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.