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Diabetes Mellitus Type 2NCT07635121

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

A study testing Low-calorie MIND-HK diet and Very Low-calorie MIND-HK diet in people with Diabetes Mellitus Type 2, run by Hong Kong Metropolitan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
Low-calorie MIND-HK diet and Very Low-calorie MIND-HK diet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
No sites listed yet
Study dates
1 Jul 2026to 31 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Queenie Law, PhD contact

3970 2974

qlaw@hkmu.edu.hk

About this study

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.

Read the 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.

Being tested
Low-calorie MIND-HK diet, Very Low-calorie MIND-HK diet, Control group
Keywords
Very low-calorie MIND-HK diet, Low-calorie MIND-HK diet, KetoMetrics Breath Ketone System
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Low-calorie MIND-HK dietBehavioural

    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.

  • Very Low-calorie MIND-HK dietBehavioural

    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.

  • Control groupOther

    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).

Study groups in NCT07635121
Study groupRoleWhat they receive
Low-calorie MIND-HK dietExperimentalLow-calorie MIND-HK diet is based on the MIND diet originally developed by Morris and colleagues in 2015 (1, 2) and adapted from the Arjmand group's 3-month MIND diet intervention (5). The Low-calorie MIND-HK diet intervention will be a 12-week nutrition program consisting of four in-person nutrition counselling sessions (one session per week, 60 minutes per session and 30 minutes question and answer session) in an activity room at each participating community centre. All sessions will be conducted by a registered nutritionist. In the nutrition sessions, the participants will learn to modify their diet to meet the low-calorie MIND-HK diet guidelines.
Receives: Behavioral: Low-calorie MIND-HK diet
Very Low-calorie MIND-HK dietExperimentalVery Low-calorie MIND-HK diet is based on the MIND diet originally developed by Morris and colleagues in 2015 (1, 2) and adapted from the Arjmand group's 3-month MIND diet intervention (5). The very Low-calorie MIND-HK diet intervention will be a 12-week nutrition programme consisting of four in-person nutrition counselling sessions (one session per week, 60 minutes per session and 30 minutes question and answer session) in an activity room at each participating community centre. All intervention sessions will be conducted by a registered nutritionist. In the nutrition sessions, the participants will learn to modify their diet to meet the low-calorie diet guidelines. As a reference, a 7-day sample menu that meets the required number of servings per day will be provided. To maintain consistency, one nutritionist and one research assistant, will administer the intervention.
Receives: Behavioral: Very Low-calorie MIND-HK diet
Control groupOtherAn 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) (6).
Receives: Other: Control group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The point of care test (POCT) of HbA1C level

    Change in HbA1C level The HbA1C will be measured by A1CNow system

    Measured: 12 weeks

Secondary outcomes (7)

  1. Change in lipid profile

    Change in lipid profile measured by CardioChek

    Measured: 12 weeks

  2. Change in basic anthropometric measurement

    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.

    Measured: 12 weeks

  3. Change in blood pressure

    Change in blood pressure. Measured using Omron M7 blood pressure monitors to assess brachial blood pressure.

    Measured: 12 weeks

  4. Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version

    Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version: Used to assess participants' diabetes self-care activities.

    Measured: 12 weeks

  5. Change in breath ketone

    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.

    Measured: 12 weeks

  6. Change in MIND-HK diet adherence score

    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.

    Measured: 12 weeks

  7. Change in fasting blood glucose

    Change in fasting blood glucose measured by CardioChek

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 Jan 2029 (estimated)
  4. Study completion31 Jan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07635121
Sponsor's protocol ID
HE-OT2025/25
Status last verified
Jul 2026
First submitted
3 Jun 2026
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15.

    PubMed 26086182

  • Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. 2015 Sep;11(9):1007-14. doi: 10.1016/j.jalz.2014.11.009. Epub 2015 Feb 11.

    PubMed 25681666

  • Kashyap A, Mackay A, Carter B, Fyfe CL, Johnstone AM, Myint PK. Investigating the Effectiveness of Very Low-Calorie Diets and Low-Fat Vegan Diets on Weight and Glycemic Markers in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis. Nutrients. 2022 Nov 17;14(22):4870. doi: 10.3390/nu14224870.

    PubMed 36432557

  • 4. International Diabetes Federation. (2025). IDF global clinical practice recommendations for managing type 2 diabetes - 2025. Retrieved from https://idf.org/t2d-cpr-2025

  • Arjmand G, Abbas-Zadeh M, Eftekhari MH. Effect of MIND diet intervention on cognitive performance and brain structure in healthy obese women: a randomized controlled trial. Sci Rep. 2022 Feb 21;12(1):2871. doi: 10.1038/s41598-021-04258-9.

    PubMed 35190536

  • 6. Hohenschurz-Schmidt, D., Vase, L., Scott, W., Annoni, M., Ajayi, O. K., Barth, J., Bennell, K., Berna, C., Bialosky, J., Braithwaite, F., Finnerup, N. B., de C Williams, A. C., Carlino, E., Cerritelli, F., Chaibi, A., Cherkin, D., Colloca, L., Côté, P., Darnall, B. D., Evans, R., Fabre, L., Faria, V., French, S., Gerger, H., Häuser, W., Hinman, R. S., Ho, D., Janssens, T., Jensen, K., Johnston, C., Juhl Lunde, S., Keefe, F., Kerns, R. D., Koechlin, H., Kongsted, A., Michener, L. A., Moerman, D. E., Musial, F., Newell, D., Nicholas, M., Palermo, T. M., Palermo, S., Peerdeman, K. J., Pogatzki-Zahn, E. M., Puhl, A. A., Roberts, L., Rossettini, G., Tomczak Matthiesen, S., Underwood, M., Vaucher, P., Vollert, J., Wartolowska, K., Weimer, K., Werner, C. P., Rice, A. S. C., & Draper-Rodi, J. (2023). Recommendations for the development, implementation, and reporting of control interventions in efficacy and mechanistic trials of physical, psychological, and self-management therapies: The CoPPS Statement. British Medical Journal, 381, e072108. https://doi.org/10.1136/bmj-2022-072108

  • Lean MEJ, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Welsh P, Kean S, Ford I, McConnachie A, Messow CM, Sattar N, Taylor R. Durability of a primary care-led weight-management intervention for remission of type 2 diabetes: 2-year results of the DiRECT open-label, cluster-randomised trial. Lancet Diabetes Endocrinol. 2019 May;7(5):344-355. doi: 10.1016/S2213-8587(19)30068-3. Epub 2019 Mar 6.

    PubMed 30852132

  • Lean ME, Leslie WS, Barnes AC, Brosnahan N, Thom G, McCombie L, Peters C, Zhyzhneuskaya S, Al-Mrabeh A, Hollingsworth KG, Rodrigues AM, Rehackova L, Adamson AJ, Sniehotta FF, Mathers JC, Ross HM, McIlvenna Y, Stefanetti R, Trenell M, Welsh P, Kean S, Ford I, McConnachie A, Sattar N, Taylor R. Primary care-led weight management for remission of type 2 diabetes (DiRECT): an open-label, cluster-randomised trial. Lancet. 2018 Feb 10;391(10120):541-551. doi: 10.1016/S0140-6736(17)33102-1. Epub 2017 Dec 5.

    PubMed 29221645

  • Taheri S, Zaghloul H, Chagoury O, Elhadad S, Ahmed SH, El Khatib N, Amona RA, El Nahas K, Suleiman N, Alnaama A, Al-Hamaq A, Charlson M, Wells MT, Al-Abdulla S, Abou-Samra AB. Effect of intensive lifestyle intervention on bodyweight and glycaemia in early type 2 diabetes (DIADEM-I): an open-label, parallel-group, randomised controlled trial. Lancet Diabetes Endocrinol. 2020 Jun;8(6):477-489. doi: 10.1016/S2213-8587(20)30117-0.

    PubMed 32445735

  • Gummesson A, Nyman E, Knutsson M, Karpefors M. Effect of weight reduction on glycated haemoglobin in weight loss trials in patients with type 2 diabetes. Diabetes Obes Metab. 2017 Sep;19(9):1295-1305. doi: 10.1111/dom.12971. Epub 2017 May 22.

    PubMed 28417575

  • Sattar N, Welsh P, Leslie WS, Thom G, McCombie L, Brosnahan N, Richardson J, Gill JMR, Crawford L, Lean MEJ. Dietary weight-management for type 2 diabetes remissions in South Asians: the South Asian diabetes remission randomised trial for proof-of-concept and feasibility (STANDby). Lancet Reg Health Southeast Asia. 2023 Feb;9:100111. doi: 10.1016/j.lansea.2022.100111.

    PubMed 36777452

  • Hocking SL, Markovic TP, Lee CMY, Picone TJ, Gudorf KE, Colagiuri S. Intensive Lifestyle Intervention for Remission of Early Type 2 Diabetes in Primary Care in Australia: DiRECT-Aus. Diabetes Care. 2024 Jan 1;47(1):66-70. doi: 10.2337/dc23-0781.

    PubMed 37840461

Questions about this trial

What is this clinical trial studying?

A study testing Low-calorie MIND-HK diet and Very Low-calorie MIND-HK diet in people with Diabetes Mellitus Type 2, run by Hong Kong Metropolitan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Queenie Law, PhD (3970 2974, qlaw@hkmu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The point of care test (POCT) of HbA1C level (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07635121, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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