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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое Low-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.
• Поведенческое Very 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 compli
• Другое Control 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).

Первичные конечные точки

• The point of care test (POCT) of HbA1C level [Срок оценки: 12 weeks]

Вторичные конечные точки (7)

• Change in lipid profile [Срок оценки: 12 weeks]
• Change in basic anthropometric measurement [Срок оценки: 12 weeks]
• Change in blood pressure [Срок оценки: 12 weeks]
• Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version [Срок оценки: 12 weeks]
• Change in breath ketone [Срок оценки: 12 weeks]
• Change in MIND-HK diet adherence score [Срок оценки: 12 weeks]
• Change in fasting blood glucose [Срок оценки: 12 weeks]

Критерии участия

Критерии включения

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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 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,
• 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 PMID 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-rando PMID 29221645

Идентификаторы

NCT: NCT07635121 · HE-OT2025/25

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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