NCT07663123

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
225

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Aug 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 10, 2026

Expected
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

2.7 years

First QC Date

June 17, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

PrediabetesType 2 Diabetes preventionNutritionMetabolic dysfunction

Outcome Measures

Primary Outcomes (1)

  • Change in Haemoglobin A1c (HbA1c) levels

    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

Study Arms (3)

High glycaemic index rice (HGI)

EXPERIMENTAL

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.

Dietary Supplement: Functional rice variaties

Low glycaemic index rice (LGI)

EXPERIMENTAL

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.

Dietary Supplement: Functional rice variaties

Low glycaemic index high protein rice (LGI-HP)

EXPERIMENTAL

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.

Dietary Supplement: Functional rice variaties

Interventions

Functional rice variatiesDIETARY_SUPPLEMENT

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.

High glycaemic index rice (HGI)Low glycaemic index high protein rice (LGI-HP)Low glycaemic index rice (LGI)

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 34578981BACKGROUND
  • 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.

    PMID: 32358482BACKGROUND
  • 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.

    PMID: 38599522BACKGROUND
  • 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.

    PMID: 38866975BACKGROUND

MeSH Terms

Conditions

Prediabetic StateDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Johan G. Eriksson, MD

    A*STAR Institute for Human Development and Potential (A*STAR IHDP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johan G. Eriksson, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single-blinded parallel randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Executive Director

Study Record Dates

First Submitted

June 17, 2026

First Posted

June 23, 2026

Study Start (Estimated)

August 10, 2026

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Last Updated

June 23, 2026

Record last verified: 2026-06