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临床试验/NCT01814358
NCT01814358撤回1 期

Effects of Pre-meal Whey Protein Ingestion on Daily Glycemic Control and Oxidative Stress Mediated Postprandial Inflammation and Vascular Dysfunction Evoked by Consumption of a High-glycemic Meal

University of California, Los Angeles2 个研究点 分布在 1 个国家开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
1 期
状态
撤回
试验地点
2
主要终点
Average 24 hour glucose

研究概览

简要总结

Risk for heart and blood vessel diseases is increased when blood sugar rises. Blood vessel dysfunction is common to such diseases. Elevated blood sugar after eating promotes blood vessel dysfunction. Dietary factors other than carbohydrates influence rises and falls in blood sugar. Dietary protein is associated with improved blood sugar control. Whey protein effectively blunts the rise in blood sugar after consuming a carbohydrate rich drink/meal in normal weight and obese adults. This study will investigate the efficacy of drinking a whey protein beverage prior to eating for improved daily blood sugar control in normal weight and obese adults in the "real world." Also, the study will test this dietary approach to reduce blood vessel dysfunction associated with eating a meal that causes blood sugar to rise. 24 normal weight and 24 obese men and premenopausal women (18-50y) will participate. Subjects will wear a sensor to monitor daily blood sugar changes in response to their typically consumed diets for 2 days. Subjects will report to the UCLA CTRC the morning after the monitoring period for measurement of blood vessel function after eating a breakfast cereal meal. Blood samples will be obtained before and after the meal to measure relevant health markers. Subjects will repeat the 2-day diet and breakfast cereal meal challenge after a week or more, and will consume either a chocolate flavored 1) whey protein or 2) gelatin protein (control) shake prior to each meal. Neither subjects nor researchers will know which protein ("double blind"). Subjects will receive the alternate protein intervention after another week or more ("crossover"). We think drinking the protein shake prior to meals will reduce daily blood sugar rises and falls after eating and blunt the blood vessel dysfunction that results from eating the breakfast cereal.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-50 years
  • BMI between 18.5 and 25 or ≥ 30
  • Willingness to provide written informed consent

排除标准

  • Pregnant or breastfeeding currently or in prior 6 months
  • Menopause in women
  • Regular consumption of > 1 serving per day of milk/yogurt
  • Known heart arrhythmia
  • Use of tobacco products
  • Any disease/pathological condition known to influence outcomes
  • Use of medications/dietary supplements known to influence outcomes
  • Recent or planned changes in diet/exercise

结局指标

主要结局

Average 24 hour glucose

时间窗: 48 hours

The 24-hour glucose level (average of 48-hour monitoring period) for whey protein arm compared to other protein arm

次要结局

  • Glycemic variability(48 hours)
  • Post-meal monocyte inflammatory signaling(60 minutes)
  • Post-meal percent change femoral artery blood flow (FBF)(120 minutes)
  • Post-meal percent change Brachial Artery Flow Mediated Dilation (FMD)(120 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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