Whey Protein Ingestion and Glucose Control in Pre- and Post Diabetic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Whole body protein turnover
研究概览
简要总结
To examine the effects of twice daily whey protein consumption on blood glucose and insulin in pre-diabetic and diabetic individuals
详细描述
Protein consumption in the morning has been shown to reduce appetite and caloric intake (19). In addition, premeal whey consumption reduces post prandial blood glucose, reduces gastric emptying rate, and increases peak blood insulin (10). Thus, it is proposed that ingestion of whey protein within 1hr of waking (and prior to breakfast) and 30 minutes prior to dinner will be more effective in suppressing appetite, carbohydrate intake, and glucose AUC. Ingestion upon waking will mitigate the cortisol-induced drive for carbohydrate intake. Ingestion prior to dinner, the most frequently consumed and largest meal in America (20), will reduce food intake, post meal blood glucose, and insulin area under the curve (21).
Specific Aims
- Determine the effect of WP ingestion within 1hr of waking and prior to breakfast, and 30min prior to dinner, on appetite suppression, carbohydrate and caloric intake, and 24hr glucose AUC over 7d in pre-diabetic (A1C 5.7%-6.4%) and diabetic (A1C 6.5%-7.5%) individuals.
- Determine the effect of WP ingestion within 1hr of waking and 30min prior to dinner on changes in OGTT, Matsuda index, and whole-body protein balance (compared to control) before and after 7d of WP consumption in pre-diabetic and diabetic individuals.
- Determine outcome differences between pre-diabetic and diabetic individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 50-70 years.
- •Body mass index between 25-45 kg/m2
- •Capable of providing informed consent.
- •COVID-19 negative and/or asymptomatic.
- •Willing to abstain from drinking alcohol or consuming marijuana and CBD products during the 7-day study meal period on two occasions.
- •HbA1c: 5.7-6.4% or 6.5% to 7.5% or fasting glucose ≥100 mg/dL
排除标准
- •Subject who does not/will not eat dairy protein sources.
- •Subjects taking exogenous insulin injections or GLP /GIP injections or other appetite suppressants.
- •Unwilling to keep a detailed 7 day food journal on two occasions
- •Unwilling to wear a CGM for 7 days on two occasions and share the data with the research team.
- •Lactose intolerance.
- •Hemoglobin <10g/dL at screening.
- •History of chemotherapy or radiation therapy for cancer in the 6 months prior to enrollment.
- •History of gastrointestinal bypass/reduction surgery.
- •Pregnant or lactating individuals.
- •History of a chronic inflammatory disease (e.g. Lupus, Crohn's disease)
- •Currently receiving androgen (e.g., testosterone) or anabolic (e.g., GH, IGF-I) therapy.
- •Currently using corticosteroid medications (cortisone, hydrocortisone, prednisone, etc.).
- •Unwilling to avoid using protein or amino-acid supplements during participation.
- •Unwilling to fast overnight.
- •Any medical condition or medication that the PI or clinical study staff finds contradictory to this study.
研究组 & 干预措施
Whey Protein Supplementation
Crossover study
干预措施: Whey Protein Isolate Crossover (Dietary Supplement)
Placebo Supplementation
Crossover study
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Whole body protein turnover
时间窗: 7 days
Whole body protein turnover reflects the continual synthesis and breakdown of body proteins. It can be measured at a whole-body or tissue level using stable isotope methods.
Oral Glucose Tolerance Test
时间窗: 7 days
Oral Glucose Tolerance Test (OGTT) is used to screen for or diagnose diabetes. Normal blood values for a 75 gram OGTT are: Fasting -- 60 to 99 mg/dL (3.3 to 5.5 mmol/L), 1 hour -- Less than 200 mg/dL (11.1 mmol/L), 2 hours -- Less than 140 mg/dL (7.8 mmol/L) is normal.
Blood glucose
时间窗: 7 days
Continuous glucose monitoring means using a device to automatically estimate your blood glucose level, also called blood sugar, throughout the day and night for 7 days.
次要结局
- Composite Appetite Scale(7 days)
- Dietary Intake Log(7 days)