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Not Yet Recruiting NCT07663123

Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition

Conditions: Prediabetes / Type 2 Diabetes

Sex: All
Ages: 40 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 225
Sponsor: Institute for Human Development and Potential (IHDP), Singapore

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.

Eligibility Criteria

Inclusion Criteria: 1. Males or females, aged 40 to 65 years old 2. Chinese, Malay or Indian 3. Body Mass Index between 23.0 - 32.0 kg/m2 4. Prediabetes profile as per fasting plasma glucose (≤ 6.9 mmol/L) and HbA1c level (5.7% - 6.4%) 5. Habitually consuming about 3 to 5 servings of polished white rice per day 6. No known food allergies and intolerance to food provided as part of study procedures 7. Proficient in English language 8. Willing to comply to study procedures and provide written consent Exclusion Criteria: 1. Diagnosed with Type 1 or 2 diabetes mellitus/ OGTT failure during screening visit 2. 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 3. 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 4. History of bariatric surgery 5. Significant weight change (± 5 % body weight) during the last 3 months 6. Women who are pregnant, breastfeeding or planning pregnancy 7. Drug abuse within the last 5 years 8. Excessive alcohol consumption \> 2 servings per day 9. Smoking in the last 1 year 10. Following any special diet(s) which may interfere with study outcomes (eg: Ketogenic diet, intermittent fasting, calorie-deficit) 11. Major change in physical activity and/or dietary habits in the last 3 months 12. Use of oral antibiotics in the last 3 months 13. Participation in other intervention studies, which may affect study outcomes as assessed by study team 14. Staff of IHDP and SIFBI in A\*STAR

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07663123). StuddyBuddy aggregates publicly available trial information.