NCT07836673

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Oct 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
Oct 2026Mar 2027

First Submitted

Initial submission to the registry

September 10, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

September 23, 2026

Status Verified

September 1, 2026

Enrollment Period

4 months

First QC Date

September 10, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

RCT

Outcome Measures

Primary Outcomes (1)

  • Continuous blood glucose levels using CGM "FreeStyle Libre 2 sensor"

    3 hours

Secondary Outcomes (1)

  • postprandial appetite using VAS

    3 hours

Study Arms (4)

low whey protein

EXPERIMENTAL

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.

Dietary Supplement: low whey protein

moderate whey protein

EXPERIMENTAL

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.

Dietary Supplement: moderate whey protein

low pea protein

EXPERIMENTAL
Dietary Supplement: low Pea protein

moderate pea protein

EXPERIMENTAL
Dietary Supplement: Moderate Pea protein

Interventions

moderate whey proteinDIETARY_SUPPLEMENT

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.

moderate whey protein
Moderate Pea proteinDIETARY_SUPPLEMENT

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.

moderate pea protein
low whey proteinDIETARY_SUPPLEMENT

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.

low whey protein
low Pea proteinDIETARY_SUPPLEMENT

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.

low pea protein

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student, Department of Nutrition and Food Technology, School of Agriculture, The University of Jordan

Study Record Dates

First Submitted

September 10, 2026

First Posted

September 23, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

September 23, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share