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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorHong Kong Metropolitan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

aged 40 to 70 years old;

diagnosed with Type II DM; and

Chinese ethnicity and able to speak and understand Cantonese.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Low-calorie MIND-HK diet

    Behavioral

    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 diet

    Behavioral

    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 group

    Other intervention

    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).

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Low-calorie MIND-HK dietExperimental treatment 1 intervention
Group B: Very Low-calorie MIND-HK dietExperimental treatment 1 intervention
Group C: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

The point of care test (POCT) of HbA1C level

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

Time frame
12 weeks

Secondary outcomes

1

Change in lipid profile

Change in lipid profile measured by CardioChek

Time frame
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.

Time frame
12 weeks
3

Change in blood pressure

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

Time frame
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.

Time frame
12 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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