Effects of Pre-Exercise Whey and Pea Protein Intake on Glycemic Responses and Postprandial Appetite During and After Moderate-Intensity Aerobic Exercise in Jordanian Adolescents With Type 1 Diabetes: A Randomized Crossover Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Continuous blood glucose levels using CGM "FreeStyle Libre 2 sensor"
研究概览
简要总结
The goal of this clinical trial is to learn whether drinking whey protein or pea protein before exercise affects blood sugar levels and appetite in adolescents with type 1 diabetes. The study will also compare two different amounts of each type of protein.
The main questions this study aims to answer are:
- Does drinking whey or pea protein before exercise affect blood sugar levels during and after moderate-intensity exercise?
- Does the amount of protein consumed before exercise affect blood sugar levels?
- Does whey or pea protein affect feelings of hunger, fullness, and satiety after exercise?
Researchers will compare four conditions: a low and moderate amount of whey protein and a low and moderate amount of pea protein. Each participant will complete all four conditions on separate study visits, allowing researchers to compare the effects within the same person.
Participants will:
- Drink a protein beverage 45 min before exercise.
- Complete 45 min moderate-intensity aerobic exercise under supervision.
- Wear a continuous glucose monitor to measure blood sugar levels during and after exercise.
- Report their feelings of hunger, fullness, and satiety at several times during the study.
- Follow the same general food, physical activity, and diabetes management instructions before each study visit.
The study may help researchers understand whether the type and amount of protein consumed before exercise can help manage blood sugar levels and appetite around exercise in adolescents with type 1 diabetes.
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
- Single (Participant)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adolescents with T1D
- •Age: 12-18 years
- •T1D duration ≥ 1 year and HbA1c <10%
- •BMI-for Age- z-score between -2 and +2
- •Able to complete 45 min moderate-intensity aerobic exercise
- •Using CGM or willing / able to wear study CGM
- •Using multiple daily injections
排除标准
- •Medical comorbidities (celiac disease and thyroid disease),
- •Diabetes complications or gastroparesis,
- •milk protein allergy or eating disorders,
- •severe hypo/ diabetic ketoacidosis in the past 3 months
- •Age: <12 or > 18 years
- •T1D duration < 1 year or HbA1c ≥10%
- •BMI -for Age- z-score < -2 or > +2
- •Unable to exercise safely (physical limitations, intellectual disability, autism, mental health conditions)
- •Not using/willing/able to use CGM
- •Using once daily/mixed insulin regimens
研究组 & 干预措施
low whey protein
Participants will consume a whey protein beverage providing 0.25 g of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise.
干预措施: low whey protein (Dietary Supplement)
moderate whey protein
Participants will consume a whey protein beverage providing the moderate prespecified dose of protein per kg of body weight, 45 minutes before moderate-intensity aerobic exercise. They will then complete the standardized exercise session under supervision. Glucose levels and appetite will be monitored during and after exercise.
干预措施: moderate whey protein (Dietary Supplement)
low pea protein
干预措施: low Pea protein (Dietary Supplement)
moderate pea protein
干预措施: Moderate Pea protein (Dietary Supplement)
结局指标
主要结局
Continuous blood glucose levels using CGM "FreeStyle Libre 2 sensor"
时间窗: 3 hours
次要结局
- postprandial appetite using VAS(3 hours)
研究者
Sondos Al-Obaidi
PhD Student, Department of Nutrition and Food Technology, School of Agriculture, The University of Jordan
University of Jordan