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
3 de junho de 2026 atualizado por: Dr Queenie Law Pui Sze, Hong Kong Metropolitan University
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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Intervencional
Inscrição (Estimado)
180
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Queenie Law, PhD
- Número de telefone: 3970 2974
- E-mail: qlaw@hkmu.edu.hk
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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;
- 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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Low-calorie MIND-HK diet
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 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.
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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.
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Experimental: Very Low-calorie MIND-HK diet
Very 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.
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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.
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Outro: 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) (6).
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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).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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The point of care test (POCT) of HbA1C level
Prazo: 12 weeks
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Change in HbA1C level The HbA1C will be measured by A1CNow system
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12 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in lipid and glucose panel
Prazo: 12 weeks
|
Change in lipid and glucose panel measured by CardioChek
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12 weeks
|
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Change in basic anthropometric measurement
Prazo: 12 weeks
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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.
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12 weeks
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Change in blood pressure
Prazo: 12 weeks
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Change in blood pressure.
Measured using Omron M7 blood pressure monitors to assess brachial blood pressure.
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12 weeks
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Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version
Prazo: 12 weeks
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Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version: Used to assess participants' diabetes self-care activities.
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12 weeks
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Change in breath ketone
Prazo: 12 weeks
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Change in breath ketone : Used to detect ketones in the breath, indicating hyperglycemia or diabetic ketoacidosis in individuals with diabetes.
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12 weeks
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Change in MIND-HK diet adherence score
Prazo: 12 weeks
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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.
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12 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de julho de 2026
Conclusão Primária (Estimado)
31 de janeiro de 2029
Conclusão do estudo (Estimado)
31 de janeiro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
3 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
3 de junho de 2026
Primeira postagem (Real)
9 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- HE-OT2025/25
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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