Prediabetes / Type 2 DiabetesHARVESTNCT07663123
Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition
A study testing Functional rice variaties in people with Prediabetes / Type 2 Diabetes, run by Institute for Human Development and Potential (IHDP), Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Prediabetes / Type 2 Diabetes
- What is being tested?
- Functional rice variaties
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the detailed description
- 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.
- Conditions
- Prediabetes / Type 2 Diabetes
- Being tested
- Functional rice variaties
- Keywords
- Prediabetes, Type 2 Diabetes prevention, Nutrition, Metabolic dysfunction
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Dietary Supplement: Functional rice variaties |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Oct 2026 (estimated)
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Prediabetes / Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blinded parallel randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S
- Responsible party
- Principal investigator, Johan Eriksson, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Johan G. Eriksson, MD, Principal investigator, A*STAR Institute for Human Development and Potential (A*STAR IHDP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07663123
- Sponsor's protocol ID
- HARVEST
- Other IDs
- NNF25SA0112673
- Acronym
- HARVEST
- Status last verified
- Sep 2026
- First submitted
- 17 Jun 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34578981Kaur 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.
PubMed 32358482Toh 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.
PubMed 38599522Toh 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.
PubMed 38866975
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition (HARVEST) Study
- ClinicalTrials.gov ID
- NCT07663123
- Acronym / sponsor ID
- HARVEST / HARVEST
- Conditions
- Prediabetes / Type 2 Diabetes
- Keywords
- Prediabetes, Type 2 Diabetes prevention, Nutrition, Metabolic dysfunction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 23 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Single-blinded parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| High glycaemic index rice (HGI) | Experimental | Dietary Supplement: Functional rice variatiesParticipants 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. |
| Low glycaemic index rice (LGI) | Experimental | Dietary Supplement: Functional rice variatiesParticipants 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. |
| Low glycaemic index high protein rice (LGI-HP) | Experimental | Dietary Supplement: Functional rice variatiesParticipants 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. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional rice variatiesSingle-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. | Dietary supplement | High glycaemic index rice (HGI), Low glycaemic index high protein rice (LGI-HP), Low glycaemic index rice (LGI) |
Primary outcome
Change in Haemoglobin A1c (HbA1c) levels
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 34578981Camps 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.
- Background: PubMed 32358482Kaur 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.
- Background: PubMed 38599522Toh 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.
- Background: PubMed 38866975Toh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Johan G. Eriksson, MD principal investigator
A*STAR Institute for Human Development and Potential (A*STAR IHDP)
Questions about this trial
What is this clinical trial studying?
A study testing Functional rice variaties in people with Prediabetes / Type 2 Diabetes, run by Institute for Human Development and Potential (IHDP), Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Johan G. Eriksson, MD (+65 6407 0100, obgjge@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Haemoglobin A1c (HbA1c) levels (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07663123, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.