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临床试验/NCT03994276
NCT03994276已完成不适用

The Postprandial Effects After Consumption of Chick-Pea Oral Doses on Glucose, Insulin, and Gut Hormone Responses. The PEA-POD Study

King's College London2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2019年6月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Phase 1: Postprandial Glycaemia (iAUC 0-60min)

研究概览

简要总结

Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. It is now established that cellular integrity (maintenance of cell wall structure) is a key factor responsible for the low glycaemic index (GI) of pulses. The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut. Thus, cell damage results in a loss of such properties and also the potential health benefits to consumers.

This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients. We have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility (>60% resistant starch). This chickpea powder (CPP) was found to be stable under long-term storage, has a neutral taste and aroma, and showed promise as a low GI 'flour-substitute'.

This study will investigate blood sugar, insulin and gut hormone levels (post-prandial glycaemic, insulinaemic and hormone responses) following the consumption of CPP consumed at breakfast, as a drink and incorporated into a food matrix (bread).

详细描述

The nutritional and potential long-term health benefits of consuming pulses have been well documented. Pulses have a high fibre content, contribute to lowering fasting blood cholesterol levels and improving glycaemic control, and have shown also considerable promise in supporting the dietary management of cardiovascular disease (CVD), type-2 diabetes mellitus (T2DM) and obesity. They are gluten-free and are also an affordable and accessible source of starch, protein, and dietary fibre. It is now established that cellular integrity (maintenance of cell wall structure) is a key factor responsible for the low glycaemic index (GI) of pulses. The maintenance of the cell wall structure restricts starch digestion and therefore glucose production in the gut. Thus, cell damage (i.e. as occurs extensively during milling of pulses into flour) results in a loss of such properties and also the potential health benefits to consumers.

This knowledge has presented an opportunity to exploit alternative processing techniques for the manufacture of pulse-based ingredients that preserve the desirable low GI of whole pulses. Incorporation of such ingredients has the potential to lower the glycaemic and insulinaemic responses to staple food products and/or may promote satiety, thereby ameliorating the dietary management of T2D and obesity and reducing the risk factors associated with these diseases. Building on new understanding of the conditions required to preserve cellular integrity, we have successfully created a dry powder consisting predominantly of intact cells which still retains low digestibility (>60% resistant starch). This chickpea powder (CPP) was found to be stable under long-term storage, has a neutral taste and aroma, and showed promise as a low GI 'flour-substitute'.

This study will investigate blood sugar, insulin and gut hormone levels (post-prandial glycaemic, insulinaemic and hormone responses) following the consumption of CPP consumed as a drink and incorporated into a food matrix (bread). It is hypothesised that the structure of the CCP will result in a reduced post-prandial glycaemic response, while maintaining (or improving) the insulinaemic and gut hormone responses. This regulation of blood sugar levels following a meal would be beneficial for people with impaired glucose metabolism, such as T2DM. This study will consist of two phases, both utilising a three-arm, random crossover design.

Phase 1 aims to test the glucose response to unmodified CPP (i.e. has not been cooked). This will involve the consumption of the following test drinks containing 50g of available carbohydrate (i.e. starch and/or sugars): (1) Glucose (an oral glucose tolerance test, OGTT); (2) Control chickpea product (no cellular integrity); and (3) the CPP. These test drinks will be consumed in random order on three separate visits. In order to ensure the test carbohydrates remains in solution, all test drinks will be made up in an equivalent volume of 330 ml (bottled water) containing chocolate flavouring. Participants will be required to fast overnight, a capillary blood glucose measurement will be taken at t=0, followed by consumption of the test drink within 5 min. Further capillary blood glucose measurements will be taken at t=10, 20, 30, 45, 60, 90, and 120 min. Additionally, participants will be provided with a Constant Glucose Monitor (CGM) that will be applied to the upper arm 24hrs prior to the first study day. All three study visits will be completed in 12 days (The length of CGM activity). It is hypothesised that the cell wall integrity in the CPP drink will result in a reduced post-prandial glycaemic response compared to the control chickpea product and the OGTT standard.

Outcome measures: The primary outcome of Phase 1 will be the glycaemic response to the consumption of CPP drink compared to both the OGTT and control chickpea product. In vitro studies suggest that maintenance of cellular integrity will reduce the early phase of post-prandial glycaemia, as assessed by the incremental area under the curve (iAUC) iAUC0-60min and maximum blood glucose concentration (Cmax). Secondary measures such as the time to reach maximum blood glucose concentration (Tmax), iAUC0-120min and iAUC60-120min will also be assessed.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18-45 y
  • Men and women
  • Healthy (free of diagnosed diseases listed in the exclusion criteria)
  • Body Mass Index 18-35 kg/m2
  • Able to understand the information sheet and willing to comply with study protocol
  • Able to give informed written consent

排除标准

  • Those with known or suspected food allergies (particularly to wheat, as specified in the screening questionnaire and participant information form) or hypersensitivity
  • Women who are pregnant, intending to become pregnant, or breastfeeding
  • Participation in another clinical trial
  • Those who have donated blood within 3 months of the screening visit and participants for whom participation in this study would result in having donated more than 1500 millilitres of blood in the previous 12 months.
  • Body mass index <18 or >35 kg/m2
  • Full Blood Counts and Liver Function test results outside of the normal range.
  • Current smokers, or reported giving up smoking within the last 6 months History of substance abuse or alcoholism
  • Reported history of Cardiovascular disease, diabetes (or fasting glucose ≥ 7.1 mmol/L), cancer, kidney, liver or bowel disease, gastrointestinal disorder or use of drug likely to alter gastrointestinal function)
  • Blood pressure ≥160/100 mmHg
  • Total cholesterol ≥ 7.8 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
  • Medications that may interfere with the study: alpha-glucosidase inhibitors (acarbose:
  • Glucobay), insulin- sensitising drugs (metformin: Glucophage, Glucophage SR, Eucreas, Janumet; thiazolidinediones: Actos, Competact), sulfonylureas (Daonil, Diamicron, Diamicron MR, Glibenese, Minodiab, Amaryl Tolbutamide), and lipid- lowering drugs (statins, nicotinic acid, colestyramine anhydrous, ezetimibe, fibrates).
  • Other medications should be reviewed by a medical representative from KCL on a case by case basis.

结局指标

主要结局

Phase 1: Postprandial Glycaemia (iAUC 0-60min)

时间窗: 60 min

The primary endpoint is iAUC 0-60 min for plasma glucose concentrations

Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-60min)

时间窗: 60 min

The primary endpoint is iAUC 0-60 min for plasma glucose, Insulin, c-peptide and Gut hormone concentrations

次要结局

  • Phase 1: Postprandial Glycaemia (Cmax)(120 min)
  • Phase 1: Postprandial Glycaemia (Tmax)(120 min)
  • Phase 2: Postprandial Glycaemia / Insulinaemia (Cmax)(240 min)
  • Phase 1: Postprandial Glycaemia (iAUC 60-120min)(60 min)
  • Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-120min)(120 min)
  • Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 0-240min)(240 min)
  • Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 90-240min)(150 min)
  • Phase 2: Postprandial Glycaemia / Insulinaemia (Tmax)(240 min)
  • Phase 1: Postprandial Glycaemia (iAUC 0-120min)(120 min)
  • Phase 2: Postprandial Glycaemia / Insulinaemia (iAUC 30-90min)(60 min)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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