NCT07663123Toborzás még nem indult
Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition
Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition (HARVEST) Study
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. szept. 15.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 225 (tervezett)
- Első benyújtás
- 2026. jún. 17.
- Kezdés
- 2026. okt. 1.
- Elsődleges befejezés
- 2029. ápr. 30.
- Fő szponzor
- Institute for Human Development and Potential (IHDP), Singapore
- Betegségek
- 2-es típusú cukorbetegség
- NCT-szám
- NCT07663123
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 225
- 2026. okt. 1. és az elsődleges befejezés (2029. ápr. 30.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
Szó szerint a(z) ClinicalTrials.gov forrásból, témák szerint csoportosítva. Hogy ki vehet részt, azt csak a vizsgálat csapata dönti el.
Korábbi kezelés
- 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
- Drug abuse within the last 5 years
Más betegség
- 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
- History of bariatric surgery
Egyéb
- Significant weight change (± 5 % body weight) during the last 3 months
- Women who are pregnant, breastfeeding or planning pregnancy
- 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
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 40 év – 65 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.