Dose-response Effect of an Apple Extract on Postprandial Glycaemia: a Randomised Controlled Trial. The GLU-POMME Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Postprandial Glycaemia
研究概览
简要总结
Postprandial hyperglycaemia can lead to adverse modifications to functional proteins within the body and eventually lead to the development of type 2 diabetes. Previous research by this group has shown that an apple polyphenol extract reduced hyperglycaemia following a high-carbohydrate meal. The aim of this study is to investigate the effects of lower doses of the apple extract on postprandial glycaemia, insulinaemia and plasma gastric inhibitory polypeptide concentrations following a mixed carbohydrate test meal.
详细描述
Introduction
Sharp peaks in blood glucose levels can lead to adverse modifications to functional proteins, oxidative stress and pancreatic beta cell dysfunction. It is therefore desirable to consume a diet that will allow more gradual rises in blood glucose levels after meals. Fruit polyphenols may help to limit the glucose excursion following a high carbohydrate meal. Previous research by this research group has demonstrated that 1200 mg of apple polyphenols (Appl'In™) inhibited the average incremental area under the curve (T+0 to T+30 min) of plasma glucose by 54% relative to placebo. Possible mechanisms include inhibition of intestinal enzymes and inhibition of intestinal glucose absorption by decreasing SGLT1/GLUT2 transport activity. The literature also suggests that foods rich in polyphenols exert beneficial effects on risk factors of cardiovascular disease such as hypertension, lipid metabolism and vascular function.
Study design:
A randomised, controlled, double-blind, cross-over study will be conducted. Four matched test drinks will be consumed in random order on separate study visits immediately before a mixed-carbohydrate test meal, containing either: 1) 1.2 g, 2) 0.9 g 3). 0.6 g of apple polyphenols, or 4). placebo. Postprandial changes in plasma glucose, insulin, NEFA, GIP, GLP-1 concentrations as well as changes in vascular function will be measured. Twenty-four hour urine samples will be collected for analysis of urinary polyphenol metabolites and glucose. In a sub sample of participants, a paracetamol absorption test will be incorporated via addition of 1.5 g paracetamol into the test drink.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age: 18-70 y
- •Male and female
- •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 diagnosed with Phenylketonuria (PKU)
- •Those with known or suspected food and/or paracetamol intolerances, allergies or hypersensitivity
- •Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- •Women who are breast feeding
- •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.
- •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
- •Unwilling to restrict consumption of specified high polyphenol foods for 48 h before the study
- •Weight change >3kg in preceding 2 months and body mass index <18 or >35 kg/m2
- •Blood pressure ≥160/100 mmHg
- •Total cholesterol ≥ 7.5 mmol/L; fasting triacylglycerol concentrations ≥ 5.0 mmol/L
- •Medications that may interfere with the study: alpha-glucosidase inhibitors (acarbose: Glucobay), insulin sensitizing 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); and medications that may react unpredictably with paracetamol: ketoconazole, metoclopramide, carbamazepine, phenobarbital, phenytoin, primidone, warfarin and other products containing paracetamol. Other medications should be reviewed by medical representative from KCL on a case by case basis.
- •Nutritional supplements that may interfere with the study: higher dose vitamins/minerals (>200% Recommend Nutrient Intake), B vitamins, Vitamin C, calcium, copper, chromium, iodine, iron, magnesium, manganese, phosphorus, potassium and zinc. Subjects already taking vitamin or minerals at a dose around 100% or less up to 200% of the RNI, or evening primrose/algal/fish oil supplements will be asked to maintain habitual intake patterns, ensuring that they take them every day and not sporadically. They will be advised not to stop taking supplements or start taking new supplements during the course of the study.
结局指标
主要结局
Postprandial Glycaemia
时间窗: 30 min following the test drink
Primary outcome: Area over baseline t+0-30 min for plasma glucose
次要结局
- Postprandial Insulinaemia(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Postprandial Glucose-dependent Insulinotropic Polypeptide (GIP) Concentrations(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Postprandial Glucagon-like Peptide-1 (GLP-1) Concentrations(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Postprandial Polyphenol Metabolite Concentrations(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Postprandial Non-esterified Fatty Acid (NEFA) Concentrations(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Postprandial Paracetamol Concentrations(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Vascular Function (Arteriograph Measurement)(Baseline and 60, 90, 120, 180, 240 min following the test drink)
- Postprandial C-peptide Concentrations(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Postprandial Triglyceride (TAG) Concentrations(baseline and 10, 20, 30, 45, 60, 75, 90, 120, 150, 180, 240 min following the test drink)
- Vascular Endothelial Function by Flow-mediated Dilation (FMD)(baseline and 120, 240, 300 min following the test drink)
- Blood Pressure(Baseline and 60, 90, 120, 180, 240 min following the test drink)
- Urinary Polyphenol Metabolites(0-4 h, 4-8 h, 8-24 h following the test drink)
- Urinary Glucose(0-4 h, 4-8 h, 8-24 h following the test drink)