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.
| Registry | NCT07836673 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, supportive care |
| Enrollment | 30 (Estimated) |
| Sponsor | University of Jordan (Other) |
| Conditions | T1D, T1DM |
| Interventions | low whey protein, moderate whey protein, low Pea protein, Moderate Pea protein (Dietary supplement) |
| Dates | start 2026-10-01 (estimated), primary completion 2027-02-01 (estimated), completion 2027-03-01 (estimated), first posted 2026-09-23, last updated 2026-09-23 |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| low whey protein | Experimental | Dietary Supplement: 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. |
| moderate whey protein | Experimental | 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. |
| low pea protein | Experimental | Dietary Supplement: low Pea protein | |
| moderate pea protein | Experimental | Dietary Supplement: Moderate Pea protein |
Sex: All, ages: 12 Years to 18 Years
Inclusion Criteria: * 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 Exclusion Criteria: * 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