The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)
研究概览
简要总结
The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.
详细描述
- A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study.
- Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 20 - 24.9 kg/m2
- •Healthy as determined by screening questionnaire
- •Male or Female
- •Non-smoking
- •Normal fasting plasma glucose (<5.5 mmol/L), but not below 3.3 mmol/L.
- •Prior use of acetaminophen
排除标准
- •Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD)
- •Weight loss or weight gain of more than 5 kg during the previous 2 months
- •Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid)
- •Serious medical condition (ie. Renal, liver)
- •Lack of appetite or skipping breakfast
- •Restrained eaters as defined as having a Three Factor Eating Questionnaire-Cognitive Restraint >16
- •Reported intolerance to milk or very low consumption (< 2 servings per week) as assessed by in-person screening. Or not liking of the research foods.
- •Food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise
- •Diabetes or other metabolic diseases that could interfere with study outcomes
- •Acetaminophen, codeine or opioid allergy
- •Pregnant or Breast Feeding
- •Typical alcohol consumption of not more than 4 drinks per sitting
研究组 & 干预措施
Skim Milk
Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving.
干预措施: Skim milk products (Other)
High Protein Milk
Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving.
干预措施: Skim milk products (Other)
High Protein Milk (Modified Ratio)
Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving.
干预措施: Skim milk products (Other)
Water Control
Skim milk products. Water and permeate control; 250mL serving.
干预措施: Skim milk products (Other)
Skim Milk (Modified Ratio)
Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving.
干预措施: Skim milk products (Other)
结局指标
主要结局
Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)
时间窗: 0-200 minutes
次要结局
- Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)(0-200 minutes)
- Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)(at 120 minutes)
研究者
Amanda Wright, Ph.D.
Associate Professor
University of Guelph