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.
Panoramica dello studio
Stato
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Sondos Alobaidi
- Numero di telefono: 00962796329336
- Email: sondosalobaidi@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Continuous blood glucose levels using CGM "FreeStyle Libre 2 sensor"
Lasso di tempo: 3 hours
|
3 hours
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
postprandial appetite using VAS
Lasso di tempo: 3 hours
|
3 hours
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- UJ-T1D-PRO-2026
- UJ IRB Approval Number (Altro identificatore: University of Jordan)
Piano per i dati dei singoli partecipanti (IPD)
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