About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
low whey protein
Dietary supplementParticipants 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.
moderate whey protein
Dietary supplementParticipants 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.
low Pea protein
Dietary supplementParticipants will consume a pea 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.
Moderate Pea protein
Dietary supplementParticipants will consume a pea 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.
Treatment groups
Trial outcomes
Primary outcomes
Continuous blood glucose levels using CGM "FreeStyle Libre 2 sensor"
Secondary outcomes
postprandial appetite using VAS
Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: