Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition (HARVEST)
11 de septiembre de 2026 actualizado por: Johan Eriksson, Institute for Human Development and Potential (IHDP), Singapore
Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition (HARVEST) Study
Type 2 Diabetes (T2D) represents a critical public health challenge in Singapore, with prevalence projected to reach one million residents by 2050. This epidemic is largely driven by a distinct "Asian phenotype" characterized by reduced insulin secretion capacity even at lower BMIs and a diet heavily centered on high-glycemic index (GI) white rice. While brown rice offers superior nutritional benefits, its global and local adoption remains low due to entrenched cultural preferences, shorter shelf life, and sensory barriers.
While the link between high-GI carbohydrates and metabolic dysfunction is well-documented, there is limited clinical evidence on the effects of "functional" white rice varieties specifically those engineered to combine low GI properties with significantly enhanced protein content on long-term glycemic control, metabolic and gut microbiome health in Asian populations. The importance of this research lies in its evaluation of a culturally seamless substitution strategy. By replacing conventional white rice with Low-GI (LGI) and High-Protein Low-GI (LGI-HP) varieties, the HARVEST study addresses the metabolic burden of prediabetes without requiring major behavioral shifts. The findings will provide vital mechanistic insights into glucose regulation, insulin sensitivity, and microbial dysbiosis, to provide the evidence based for nutritional strategies for T2D prevention and management.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
- To evaluate the efficacy of a 16-week intervention with functional rice varieties (LGI, LGI-HP) on chronic glycaemic management in Singaporean adults with prediabetes. It is hypothesized that dietary replacement of habitual rice with functional varieties can significantly improve metabolic health compared to the high-GI (HGI) control group
- To compare the postprandial glucose and insulin responses of LGI, LGI-HP and HGI rice under standardized acute meal testing using continuous glucose monitoring. It is hypothesized that postprandial glucose excursions and glycemic variability will be significantly attenuatated in the functional rice groups compared to the HGI group
- To characterise longitudinal shifts in gut microbiota composition and identify mechanistic correlations between microbial changes and glucose metabolism. It is hypothesized that long term consumption of functional rice will promote beneficial shift in the gut microbiome which are associated with improved glucose homeostasis.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
225
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Johan G. Eriksson, MD
- Número de teléfono: +65 6407 0100
- Correo electrónico: obgjge@nus.edu.sg
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Males or females, aged 40 to 65 years old
- Chinese, Malay or Indian
- Body Mass Index between 23.0 - 32.0 kg/m2
- Prediabetes profile as per fasting plasma glucose (≤ 6.9 mmol/L) and HbA1c level (5.7% - 6.4%)
- Habitually consuming about 3 to 5 servings of polished white rice per day
- No known food allergies and intolerance to food provided as part of study procedures
- Proficient in English language
- Willing to comply to study procedures and provide written consent
Exclusion Criteria:
- Diagnosed with Type 1 or 2 diabetes mellitus/ OGTT failure during screening visit
- History or current diagnosis of cardiovascular, endocrine, gastrointestinal, haematological, hepatitis (hepatitis B and C), cancers (except basal cell carcinoma), chronic kidney disease or other medical conditions which may affect study outcomes, as assessed by study team
- Having chronic medication (eg: metformin, oral corticosteroids etc), and/or supplements that may influence glycaemic management and other study outcomes, as assessed by study team
- History of bariatric surgery
- Significant weight change (± 5 % body weight) during the last 3 months
- Women who are pregnant, breastfeeding or planning pregnancy
- Drug abuse within the last 5 years
- Excessive alcohol consumption > 2 servings per day
- Smoking in the last 1 year
- Following any special diet(s) which may interfere with study outcomes (eg: Ketogenic diet, intermittent fasting, calorie-deficit)
- Major change in physical activity and/or dietary habits in the last 3 months
- Use of oral antibiotics in the last 3 months
- Participation in other intervention studies, which may affect study outcomes as assessed by study team
- Staff of IHDP and SIFBI in A*STAR
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: High glycaemic index rice (HGI)
Participants will replace their habitual rice consumption with 4 servings (equivalent to approximately 2 bowls or ~400 g of cooked rice) per day of HGI rice while keeping other dietary components consistent.
|
Single-blinded, 16 week parallel randomized controlled trial (RCT) involving 225 participants with prediabetes.
Participants are randomized into one of three arms to consume either high glycaemic index rice (HGI), low glycaemic index rice (LGI), or low glycaemic index high protein rice (LGI-HP).
In each arm (n = 75), participants will replace their habitual rice consumption with 4 servings (equivalent to approximately 2 bowls or ~400 g of cooked rice) per day of the assigned rice group while keeping other dietary components consistent.
|
|
Experimental: Low glycaemic index rice (LGI)
Participants will replace their habitual rice consumption with 4 servings (equivalent to approximately 2 bowls or ~400 g of cooked rice) per day of LGI rice while keeping other dietary components consistent.
|
Single-blinded, 16 week parallel randomized controlled trial (RCT) involving 225 participants with prediabetes.
Participants are randomized into one of three arms to consume either high glycaemic index rice (HGI), low glycaemic index rice (LGI), or low glycaemic index high protein rice (LGI-HP).
In each arm (n = 75), participants will replace their habitual rice consumption with 4 servings (equivalent to approximately 2 bowls or ~400 g of cooked rice) per day of the assigned rice group while keeping other dietary components consistent.
|
|
Experimental: Low glycaemic index high protein rice (LGI-HP)
Participants will replace their habitual rice consumption with 4 servings (equivalent to approximately 2 bowls or ~400 g of cooked rice) per day of LGI-HP rice while keeping other dietary components consistent.
|
Single-blinded, 16 week parallel randomized controlled trial (RCT) involving 225 participants with prediabetes.
Participants are randomized into one of three arms to consume either high glycaemic index rice (HGI), low glycaemic index rice (LGI), or low glycaemic index high protein rice (LGI-HP).
In each arm (n = 75), participants will replace their habitual rice consumption with 4 servings (equivalent to approximately 2 bowls or ~400 g of cooked rice) per day of the assigned rice group while keeping other dietary components consistent.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Haemoglobin A1c (HbA1c) levels
Periodo de tiempo: 16 weeks
|
To evaluate the efficacy of a 16-week intervention with functional rice varieties on chronic glycaemic management in Singaporean adults with prediabetes, as measured by change in Haemoglobin A1c (HbA1c) levels.
|
16 weeks
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Johan G. Eriksson, MD, A*STAR Institute for Human Development and Potential (A*STAR IHDP)
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Camps SG, Kaur B, Lim J, Loo YT, Pang E, Ng T, Henry CJ. Improved Glycemic Control and Variability: Application of Healthy Ingredients in Asian Staples. Nutrients. 2021 Sep 3;13(9):3102. doi: 10.3390/nu13093102.
- Kaur B, Koh M, Ponnalagu S, Henry CJ. Postprandial blood glucose response: does the glycaemic index (GI) value matter even in the low GI range? Nutr Diabetes. 2020 May 1;10(1):15. doi: 10.1038/s41387-020-0118-5.
- Toh DWK, Fu AS, Mehta KA, Lam NYL, Haldar S, Henry CJ. Plant-Based Meat Analogs and Their Effects on Cardiometabolic Health: An 8-Week Randomized Controlled Trial Comparing Plant-Based Meat Analogs With Their Corresponding Animal-Based Foods. Am J Clin Nutr. 2024 Jun;119(6):1405-1416. doi: 10.1016/j.ajcnut.2024.04.006. Epub 2024 Apr 8.
- Toh DWK, Ponnalagu S, Camps SG, Lim J, Koh MXN, Henry CJ. Higher adiposity predicts greater intra-individual inconsistencies in postprandial glycemic measurements-an analysis of three randomized controlled trials in Asian populations. Eur J Clin Nutr. 2024 Sep;78(9):788-795. doi: 10.1038/s41430-024-01457-1. Epub 2024 Jun 12.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de octubre de 2026
Finalización primaria (Estimado)
30 de abril de 2029
Finalización del estudio (Estimado)
30 de abril de 2029
Fechas de registro del estudio
Enviado por primera vez
17 de junio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de junio de 2026
Publicado por primera vez (Actual)
23 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
15 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
11 de septiembre de 2026
Última verificación
1 de septiembre de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- HARVEST
- NNF25SA0112673 (Otro número de subvención/financiamiento: Novo Nordisk Foundation)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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