The Effects of Apple Polyphenol Supplementation on Glucose Homeostasis in Prediabetic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Apple polyphenols and glucose homeostasis in prediabetics
研究概览
简要总结
The primary objective is to investigate the effect of apple polyphenol supplementation for 12 weeks on glucose homeostasis in prediabetic individuals. Further, this study has three secondary objectives: 1) to investigate whether daily supplementation at breakfast and dinner with apple polyphenols for 12 weeks affects the rhythm of glucose uptake over the day and reduces fasting glucose levels and postprandial glucose peaks; 2) to determine the effect of daily supplementation with apple polyphenols for 12 weeks on biomarkers of metabolic health; 3) to assess whether daily supplementation with apple polyphenols for 12 weeks alters fecal SCFA concentrations and fecal microbiota composition.
详细描述
Study Design:
45 Prediabetic adults will be included in a double-blind randomized placebo-controlled trial. All volunteers will be subjected to a 12-week period during which an apple polyphenol supplement or placebo will be ingested at breakfast and dinner. An intervention period of 12 weeks with a third visit half way of the intervention has been chosen. After 6 weeks and at the end of the study microbiota composition is measured since dietary intervention of at least 6 weeks is required to be able to measure changes in microbial composition and metabolic health. The third visit will be scheduled to monitor protocol compliance and check the well-being of subjects. Concomitant medication will be recorded as well as adverse events. In addition, subjects will be reminded about the intake of the investigational product and difficulties to compliance will be discussed. Subjects will perform an oral glucose tolerance test, blood samples are taken and fecal samples will be collected at the start of the study, half-way and at the end of the intervention period. The oral glucose tolerance test will be performed to determine glucose tolerance. During the OGTT blood glucose samples will be collected at 30, 60, 90 and 120 minutes in order to determine area under the curve of glucose as primary endpoint for the glucose tolerance. The blood samples are taken to measure whole blood glucose, serum insulin, HbA1c, metabolic profile, antioxidant levels (protocol compliance) and SCFA. The fecal samples are collected to assess the fecal microbiota composition and fecal SCFA concentration. Finally, at the start of the intervention, and after the third visit an Abott FreeStyle Libre Pro Continuous Glucose Monitoring (CGM)(Hoofddorp, The Netherlands) sensor is inserted. The Abott FreeStyle Libre Pro CGM sensor will be injected and worn for a period of 14 days after which the subjects will visit for collecting the data for continuous glucose monitoring with a recorder. The Abott FreeStyle Libre Pro is intended for use with type 2 diabetic individuals but a recent study has validated its use in prediabetic individuals (50).The baseline continuous glucose monitoring needs to be completed before the intervention will be started.
Screening and pre-testing:
Prior to the study, volunteers' suitability to participate will be assessed in a single screening session. The participants will be asked to come to the laboratory in fasted state (i.e. no eating or drinking after 22:00h the night before; drinking water is allowed) After explaining all study procedures, written informed consent will be obtained from subjects willing to participate. A signed copy of the informed consent will be provided for the subject to keep. The subject's suitability for the trial will be confirmed by the inclusion/exclusion criteria (see section 4). During screening, body weight, height and BMI (using the equation BMI = body mass (kg)/height (m)2 ) will be assessed. Subjects will be asked to fill in a medical questionnaire enquiring about their general health, medical history, GI symptoms, use of medication and sports activities. HbA1C will be measured using an Abbott™ Afinion™ 2 Analyzer (Hoofddorp, The Netherlands). Subjects will be included based on the results from BMI, and the in- and exclusion criteria discussed in the medical questionnaire. Included subjects will be instructed to collect a fecal sample to determine microbial composition- and activity and SCFA concentration. A collection kit will be provided to take home that includes a toilet hat, instructions for collecting the specimen, a collection tube, and a biohazard mailing bag. A short questionnaire about the collection time and date will be included in the collection kit as well as a dietary recall questionnaire. Food records and stool characteristics will be scored with a questionnaire and handed in by the subject at visit 1 (pre-test), as well as a fecal donation to determine microbial composition- and activity and SCFA concentration.
Test day:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
All samples and data will be coded so that no personal information about the participant can be inferred. Each subject will be assigned an individual code that will be visible on the biological samples. The code will include a participant number in chronological order and a test day number in chronological order. In addition, the label of each sample will indicate the date of collection.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged from 40 - 70 years
- •22.5 < BMI < 30 kg/m^2
- •Weight-stable for at least 90 days prior to participation (no change in bodyweight, i.e. < 3kg).
- •HbA1c: 5.7% to 6.4%
- •Fasting blood glucose levels 100 to 125 mg/dl (5.6 to 6.9 mmol/l)
排除标准
- •Subject following an overly imbalanced or restrictive diet as per nutritional advice
- •Concurrent systemic disease and/or laboratory abnormalities considered by investigators to be detrimental for the participants safety or potentially interfering with the study procedures and/or study outcome
- •Abdominal surgery interfering with gastrointestinal function, upon judgement of the medical doctor, who will decide in-or exclusion based on the surgery applied
- •Participants who received antibiotics in the 90 days prior to the start of the study
- •Use of other medication will be reviewed by a medical doctor, who will decide on in- or exclusion based on the drug(s) used
- •Use of laxatives within 14 days prior to the study
- •Using medications for gastric or intestinal complaints
- •Drug use, interfering with any of the outcome parameters of this study; to be decided by the person who is medically responsible for this study
- •Having donated blood in the 3 months prior to the study
- •Administration of antioxidant supplements, investigational drugs or participation in any scientific intervention study, which may interfere with this study (to be decided by the principle investigator), in the 14 days prior to the study
- •History of side effects towards intake of antioxidant supplements
- •Participants who have a gluten or lactose intolerance
- •Use of proton pump inhibitors
结局指标
主要结局
Apple polyphenols and glucose homeostasis in prediabetics
时间窗: 12 weeks
The primary outcome measure is the difference in glucose tolerance before and after the intervention, assessed using the oral glucose tolerance test area under the curve. Participants will undergo three oral glucose tolerance tests during the study: at the beginning, halfway, and the end. Prior to each test, participants will fast for at least 12 hours, consume a normal diet with approximately 150 grams of carbohydrate per day for three days, and avoid strenuous exercise and alcohol for at least 48 hours. During the test, participants will drink a glucose solution and have blood samples taken at various time points (0, 30, 60, 90, and 120 minutes) for analysis of glucose and insulin levels. Fasting insulin and glucose concentrations will be used to calculate insulin sensitivity using the homeostasis model assessment of insulin resistance (HOMA-IR) index. Blood samples will be stored for future use.
次要结局
- Apple polyphenols and circadian pattern of blood glucose levels(12 weeks)
- Apple polyphenols and fecal microbiota composition(12 weeks)