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
2026년 6월 3일 업데이트: 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.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
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.
연구 유형
중재적
등록 (추정된)
180
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Queenie Law, PhD
- 전화번호: 3970 2974
- 이메일: qlaw@hkmu.edu.hk
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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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실험적: 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.
|
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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The point of care test (POCT) of HbA1C level
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in lipid and glucose panel
기간: 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
기간: 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.
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12 weeks
|
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Change in blood pressure
기간: 12 weeks
|
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
기간: 12 weeks
|
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
기간: 12 weeks
|
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
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 7월 1일
기본 완료 (추정된)
2029년 1월 31일
연구 완료 (추정된)
2029년 1월 31일
연구 등록 날짜
최초 제출
2026년 6월 3일
QC 기준을 충족하는 최초 제출
2026년 6월 3일
처음 게시됨 (실제)
2026년 6월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 3일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- HE-OT2025/25
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 지원 정보 유형
- 연구_프로토콜
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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