Health Assessment of Low Glycaemic Index - High Protein Rice to Enhance Glycemic Control Through Nutrition (HARVEST)
2026年9月11日 更新者：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.
調査の概要
詳細な説明
- 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.
研究の種類
介入
入学 (推定)
225
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Johan G. Eriksson, MD
- 電話番号：+65 6407 0100
- メール：obgjge@nus.edu.sg
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
実験的：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Haemoglobin A1c (HbA1c) levels
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
捜査官
- 主任研究者：Johan G. Eriksson, MD、A*STAR Institute for Human Development and Potential (A*STAR IHDP)
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年10月1日
一次修了 (推定)
2029年4月30日
研究の完了 (推定)
2029年4月30日
試験登録日
最初に提出
2026年6月17日
QC基準を満たした最初の提出物
2026年6月17日
最初の投稿 (実際)
2026年6月23日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月15日
QC基準を満たした最後の更新が送信されました
2026年9月11日
最終確認日
2026年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。