A double blind, randomized, crossover, standard-controlled study to determine effect of Wheat Flour+ GI-Ctrl on postprandial glucose level
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 1.Postprandial glucose monitoring: Incremental increase in glucose concentration (iAUC) after standard meal consumption, comparison in response among placebo and test.
研究概览
简要总结
The rising prevalence of type 2 diabetes mellitus (T2DM) and its associated complications necessitates effective strategies to manage postprandial hyperglycemia, a key driver of disease progression. As a dietary staple across India and many other regions, wheat flour plays a central role in daily nutrition but has a high glycemic index, contributing to significant post-meal glucose spikes—especially in individuals with diabetes or those who are overweight.
This research explores the potential of modified wheat flour enriched with glycemic control ingredients (GI-Ctrl) to mitigate these spikes, offering a culturally compatible solution for better glycemic management. The study compares the effects of standard wheat flour with Wheat Flour + GI-Ctrl on postprandial glucose responses.
Key outcomes include incremental area under the glucose curve (iAUC), maximum glucose concentration (Cmax), and time to reach Cmax (Tmax), all measured via continuous glucose monitoring (CGM) to capture comprehensive, real-world glucose response patterns. Participants include individuals with T2DM as well as those who are overweight or obese (BMI 25–45 kg/m²), due to their heightened risk for glycemic dysregulation.
A double-blind, randomized crossover design enhances the study’s rigor by minimizing bias and allowing for individualized comparisons. Secondary objectives focus on safety and tolerability, particularly gastrointestinal side effects, to assess the broader feasibility of the intervention. Only stable metformin users are included to isolate the dietary effects without confounding from other glucose-lowering drugs.
Given the global reliance on wheat-based diets, this study has significant public health relevance. Scaling the Wheat Flour + GI-Ctrl intervention could offer an accessible, dietary-based strategy to improve glycemic control and quality of life among at-risk populations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects with limited physical activity
- •BMI: 25 to 45 Kg/m2
- •Subjects taking stable medicine dose for past 3 months.
- •For diabetic group, subjects who are consuming biguanides (Metformin) for blood glucose control
- •Subjects willing to give written informed consent and adhere to all the requirements of this protocol.
排除标准
- •1.Pregnant and lactating female.
- •2.Subjects with BMI More than or equal to
- •3.Type I diabetic patients 4.Subjects who are taking any sugar control supplements 5.Subjects who are under the DPP-4 inhibitor, incretin mimetic, glucosidase inhibitor, rapid acting/short acting/ intermediate acting and premixed insulin-based treatment.
- •6.Subject with major chronic complications (including but not limited to) autoimmune disease, inflammation, etc.
- •Subject consuming any drug other than metformin.
- •7.Organic insufficiency (cardiac, hepatic, renal, respiratory) 8.Chronic smoking and alcohol intake 9.Allergy to the ingredients in the test product.
- •10.History of any surgery in the past 3 months.
- •11.Subject currently taking or has in the past 30 days used GI related probiotics/prebiotics or any enzymes [prescription or over the counter (OTC)].
结局指标
主要结局
1.Postprandial glucose monitoring: Incremental increase in glucose concentration (iAUC) after standard meal consumption, comparison in response among placebo and test.
时间窗: 16 days
次要结局
- 1.Determination of maximum glucose concentration (Cmax) after standard meal consumption(2.Evaluation of time required to reach maximum glucose concentration (Tmax) after standard meal consumption)