The Pudding Study: The Effect of Effect of Fibre-enriched Pudding Products on Glycemic and Satiety Response in Adults at Risk for Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Fasting and postprandial insulin response for each pudding and control product
研究概览
简要总结
The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product.
详细描述
The purpose of this study is to determine the specific properties of a variety of dietary fibres that lead to different postprandial glycemic and satiety responses in individuals at risk for type 2 diabetes. This is accomplished by utilizing a variety of dietary fibres that demonstrate a wide range of properties in a pudding product, and by examining the ability of each of these to limit gastric emptying, limit glucose absorption, limit insulin secretion, and improve satiety, versus a low fibre control product. To accomplish this, a randomized, double-blinded, placebo controlled, crossover study design will be used, in order to determine the different effects of a variety of fibre-enriched pudding products on markers of type 2 diabetes and satiety response, versus low-fibre control puddings.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 否
入选标准
- •Men/Women
- •Age 18-70 years
- •CANRISK Questionnaire score ≥21 (brief questionnaire that identifies risk of diabetes)
- •BMI ≥25 and <40 kg/m2
- •Prior use of acetaminophen
排除标准
- •Food allergies or any life-threatening allergy (food or otherwise)
- •Acetaminophen allergy
- •Gastrointestinal conditions or illnesses (Including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD))
- •Serious major medical condition (i.e. renal, liver)
- •Pregnant or breastfeeding
- •Food Neophobia Scale score between 30 and 54 (Food Neophobia Scale is a questionnaire which is intended to screen out individuals who are unsure of consuming new products)
- •TFEQ-CR >16 (TFEQ is a questionnaire to screen for restrained eaters)
- •Alcohol consumption>4 drinks/sitting
- •Medication or natural health products (NHPs) used for diabetes (glycemic control)
- •Medication or NHPs contraindicated with acetaminophen
- •Recent or intended significant weight loss or gain (i.e. >4 kg in previous 3 months)
研究组 & 干预措施
Tapioca Starch - Low-Fibre
Tapoica starch pudding without added fibre
干预措施: Yellow Mustard Gum Fibre (Other)
High Maltose Corn Syrup - Low-Fibre
High maltose corn syrup pudding without added fibre
干预措施: Yellow Mustard Gum Fibre (Other)
Trutol Glucose Beverage (#1)
Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at first treatment study visit.
干预措施: Yellow Mustard Gum Fibre (Other)
Trutol Glucose Beverage (#2)
Trutol Glucose Beverage containing 50 g of glucose without added fibre. Consumed at final treatment study visit.
干预措施: Yellow Mustard Gum Fibre (Other)
Yellow Mustard Gum Fibre - Tapioca Starch
Yellow mustard gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
干预措施: Yellow Mustard Gum Fibre (Other)
Yellow Mustard Gum Fibre - High Maltose Corn Syrup
Yellow mustard gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
干预措施: Yellow Mustard Gum Fibre (Other)
Soluble Flaxseed Gum Fibre - Tapioca Starch
Soluble flaxseed gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
干预措施: Soluble Flaxseed Gum Fibre (Other)
Soluble Flaxseed Gum Fibre - High Maltose Corn Syrup
Soluble flaxseed gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
干预措施: Soluble Flaxseed Gum Fibre (Other)
Fenugreek Gum Fibre - Tapioca Starch
Fenugreek gum fibre pudding containing tapioca starch. Fibre-enriched treatment product.
干预措施: Fenugreek Gum Fibre (Other)
Fenugreek Gum Fibre - High Maltose Corn Syrup
Fenugreek gum fibre pudding containing high maltose corn syrup. Fibre-enriched treatment product.
干预措施: Fenugreek Gum Fibre (Other)
结局指标
主要结局
Fasting and postprandial insulin response for each pudding and control product
时间窗: Blood insulin will be analyzed for each each study visit (10 in total), at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Insulin will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Fasting and postprandial acetaminophen absorption for each pudding and control product
时间窗: Blood acetaminophen will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Acetaminophen will be measured in the fasting state and postprandially through finger prick blood samples at each study treatment visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Fasting and postprandial blood glucose response for each pudding and control product
时间窗: Blood glucose will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Blood glucose will be measured in the fasting state and postprandially through finger prick blood samples at each study visit. Participants will have an initial fasted blood sample taken, then consume one of 10 treatment products over a 10 minute period, and will then have blood taken at 15, 30, 60, 90, and 120 minute intervals. This will occur once a week for 10 weeks until all treatments have been consumed.
Satiety-producing effect for each pudding and control product
时间窗: Satiety will be analyzed for each study visit (10 in total) at times 0 (fasting), 15, 30, 60, 90, and 120 minutes, to compare responses between different treatment products.
Participants will complete visual analogue scale (VAS) questionnaires during each treatment visit to subjectively measure satiety. They will be asked to complete an initial VAS questionnaire when fasted, and will then consume one of 10 treatments within 10 minutes, and complete VAS questionnaires 5 minutes before each blood sample at times 10, 25, 55, 85, and 115 minutes. After 120 minutes have passed, participants will consume an ad libitum pizza lunch buffet meal to objectively measure satiety, and once comfortably full they will complete a final VAS questionnaire. Weighed food records will be used to objectively measure food intake for the rest of the day. This will occur once a week for 10 weeks until all treatments have been consumed.
次要结局
- 3-Day food records(Over 3 days before the first treatment study visit)
研究者
Alison Duncan
Professor
University of Guelph