Postprandial Glycaemic Response to Barnyard Millet Functional Foods Fortified with Plant-Based Functional Phytochemicals: A Randomized Crossover Trial in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To assess glycemic index using blood sugar levels
研究概览
简要总结
The glycemic index (GI) is a measure of the blood glucose-raising potential of the Carbohydratecontent of a food compared to a reference food
(generally pure glucose) (https://lpi.oregonstate.edu/mic/food-beverages/glycemic-index-glycemic-load). It is measured in a scale of 0-100 where below 55 is considered as lowglycemic index, 56- 69 as medium glycemic index and 70 and above as high glycemic index.Foods that have refined sugar contents have generally more glycemic index and might affectthe
blood sugar levels whereas foods with typically less sugar and more fibre have less glycemicindex. Subjects who fulfil the eligibility criteria will be enrolled in the study after
signing the informed consent form. Present study is aimed to evaluate the glycemic index of Four food products
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Healthy adults (based on medical history and screening tests) in the age group of 18 and 45 years – subjects 2.Fasting blood glucose levels less than or equal to 100mg/dL.
- •3.Glycosylated Hemoglobin (HbA1c) less than or equal to 100mg/dL.
- •5.6 as per American Diabetes Association (ADA) 4.BMI should be between 18.5 to 25 kg/m2 5.HOMA-IR (Homeostasis Model Assessment of Insulin Resistance) less than or equal to 100mg/dL.2.5 as per American Diabetes Association (ADA) 6.Lipid profile (Total cholesterol) within normal range as applicable 7.Must be willing to give written informed consent and comply with the study procedures.
- •8.Subject’s complete blood count parameters to be within clinically acceptable range by Investigator.
- •9.Willing to abstain from other functional foods or supplements during the study 10.Not currently on any medication or supplement affecting glucose, lipid, or weight metabolism.
排除标准
- •1.Subjects particularly on any special diet 2.Subjects suffering from any systemic disorders (diabetes mellitus, cardiovascular, renal, pulmonary, endocrine, or neurological disorders, ulcers, dermatologic disorders, autoimmune diseases) or severe food allergies; an active infectious disease (HBV, HCV, HIV) 3.current diagnosis or a history of relevant depressive episodes or of panic attacks, psychosis, bipolar or eating disorders 4.Patient having participated in any other clinical trial within one month prior to screening 5.Current use of Use of medications or supplements that affect outcomes 6.Allergy or intolerance to millets, cereals, fenugreek, cinnamon, moringa, or any study ingredients 7.Any other medical condition or circumstance that, in the investigator’s judgment, would make participation unsafe.
结局指标
主要结局
To assess glycemic index using blood sugar levels
时间窗: To assess glycemic index using blood sugar levels of test products measured at fixed intervals (-5, 15, 30, 45, 60, 90 and 120 min
次要结局
- Glycaemic Index(GI) of the test product assessing C-peptide levels(at -5min and after 120 min)
研究者
Dr Madhusudan C
NRR Hospital