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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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

180

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comportamentale: 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.
Sperimentale: 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.
Comportamentale: 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.
Altro: 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).
Altro: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
The point of care test (POCT) of HbA1C level
Lasso di tempo: 12 weeks
Change in HbA1C level The HbA1C will be measured by A1CNow system
12 weeks

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in lipid and glucose panel
Lasso di tempo: 12 weeks
Change in lipid and glucose panel measured by CardioChek
12 weeks
Change in basic anthropometric measurement
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Hong Kong Metropolitan University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 luglio 2026

Completamento primario (Stimato)

31 gennaio 2029

Completamento dello studio (Stimato)

31 gennaio 2029

Date di iscrizione allo studio

Primo inviato

3 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

3 giugno 2026

Primo Inserito (Effettivo)

9 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • HE-OT2025/25

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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