Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition (HARVEST)
11 septembre 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
- 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.
Type d'étude
Interventionnel
Inscription (Estimé)
225
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Johan G. Eriksson, MD
- Numéro de téléphone: +65 6407 0100
- E-mail: obgjge@nus.edu.sg
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
|
Expérimental: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Haemoglobin A1c (HbA1c) levels
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Johan G. Eriksson, MD, A*STAR Institute for Human Development and Potential (A*STAR IHDP)
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 octobre 2026
Achèvement primaire (Estimé)
30 avril 2029
Achèvement de l'étude (Estimé)
30 avril 2029
Dates d'inscription aux études
Première soumission
17 juin 2026
Première soumission répondant aux critères de contrôle qualité
17 juin 2026
Première publication (Réel)
23 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
15 septembre 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
11 septembre 2026
Dernière vérification
1 septembre 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- HARVEST
- NNF25SA0112673 (Autre subvention/numéro de financement: Novo Nordisk Foundation)
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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