Diabetes Mellitus Type 2
Conditions
Keywords
Very low-calorie MIND-HK diet, Low-calorie MIND-HK diet, KetoMetrics Breath Ketone System
Brief 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.
Detailed description
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.
Interventions
OTHERControl group
An attention control group will receive the same amount of attention in four in-person infectious disease counselling sessions (one session per week, 60 minutes per session, and a 30- minute question and answer session).
BEHAVIORALLow-calorie MIND-HK diet
This 12-week community-based lifestyle intervention is designed to help participants modify their daily intake to meet low-calorie MIND-HK dietary guidelines. The program includes four weekly education sessions (60-minute lesson and 30-minute Q\&A) covering portion control and food groups, alongside continuous monitoring of dietary logs to track compliance and support self-management throughout the study period.
BEHAVIORALVery Low-calorie MIND-HK diet
This 12-week community-based lifestyle intervention is designed to help participants modify their daily intake to meet very low-calorie MIND-HK dietary guidelines. Administered by a consistent team of one nutritionist and one research assistant to ensure program fidelity, the intervention includes four weekly sessions (60-minute lesson and 30-minute Q\&A) covering calorie-reduction strategies, alongside the distribution of structured sample menus and continuous tracking to support dietary compliance.
Sponsors
Hong Kong Metropolitan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. aged 40 to 70 years old; 2. diagnosed with Type II DM; and 3. Chinese ethnicity and able to speak and understand Cantonese.
Exclusion criteria
1. patients on dialysis; 2. Type I and Type II DM patients with insulin use; 3. 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); 4. Pregnant or Breastfeeding Women; 5. 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; 6. People with low BMI less than 18.5; 7. participation ni any dietary program within the past 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The point of care test (POCT) of HbA1C level | 12 weeks | Change in HbA1C level The HbA1C will be measured by A1CNow system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in lipid profile | 12 weeks | Change in lipid profile measured by CardioChek |
| Change in basic anthropometric measurement | 12 weeks | Change in basic anthropometric measurement: a. Height and waist will be measured in meters using a tape measure. b. Weight will be measured in kilograms using a scale. c. Weight and height will be combined to report Body Mass index (BMI) in kg/m\^2. |
| Change in blood pressure | 12 weeks | Change in blood pressure. Measured using Omron M7 blood pressure monitors to assess brachial blood pressure. |
| Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version | 12 weeks | Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version: Used to assess participants' diabetes self-care activities. |
| Change in breath ketone | 12 weeks | Change in breath ketone will be measured using the portable KetoMetrics® Breath Ketone System : Used to detect ketones in the breath, indicating hyperglycemia or diabetic ketoacidosis in individuals with diabetes. |
| Change in MIND-HK diet adherence score | 12 weeks | Change in MIND-HK diet adherence score based on 14 components- nine healthy and five unhealthy food groups (excluding wine). Each group is scored 0.0, 0.5, or 1.0, with higher scores reflecting healthier intake, for a total score ranging from O to 14. |
| Change in fasting blood glucose | 12 weeks | Change in fasting blood glucose measured by CardioChek |
Contacts
CONTACTQueenie Law, PhD
Outcome results
None listed