Pre-Exercise Whey and Pea Protein in Adolescents With Type 1 Diabetes
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.
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.
Aperçu de l'étude
Statut
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sondos Alobaidi
- Numéro de téléphone: 00962796329336
- E-mail: sondosalobaidi@gmail.com
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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. |
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. |
|
Expérimental: 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. |
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. |
|
Expérimental: low pea protein
|
Participants 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. |
|
Expérimental: moderate pea protein
|
Participants 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
|
Continuous blood glucose levels using CGM "FreeStyle Libre 2 sensor"
Délai: 3 hours
|
3 hours
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
postprandial appetite using VAS
Délai: 3 hours
|
3 hours
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- UJ-T1D-PRO-2026
- UJ IRB Approval Number (Autre identifiant: University of Jordan)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .