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

June 3, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Behavioral: 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.
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.
Behavioral: 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 compliance.
Other: 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).
Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The point of care test (POCT) of HbA1C level
Time Frame: 12 weeks
Change in HbA1C level The HbA1C will be measured by A1CNow system
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lipid and glucose panel
Time Frame: 12 weeks
Change in lipid and glucose panel measured by CardioChek
12 weeks
Change in basic anthropometric measurement
Time Frame: 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.
12 weeks
Change in blood pressure
Time Frame: 12 weeks
Change in blood pressure. Measured using Omron M7 blood pressure monitors to assess brachial blood pressure.
12 weeks
Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version
Time Frame: 12 weeks
Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version: Used to assess participants' diabetes self-care activities.
12 weeks
Change in breath ketone
Time Frame: 12 weeks
Change in breath ketone : Used to detect ketones in the breath, indicating hyperglycemia or diabetic ketoacidosis in individuals with diabetes.
12 weeks
Change in MIND-HK diet adherence score
Time Frame: 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.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

January 31, 2029

Study Completion (Estimated)

January 31, 2029

Study Registration Dates

First Submitted

June 3, 2026

First Submitted That Met QC Criteria

June 3, 2026

First Posted (Actual)

June 9, 2026

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE-OT2025/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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