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Investigating the effect of whey protein ingestion on post-exercise hypoglycaemia following resistance exercise in people with type 1 diabetes.

Investigating the effect of whey protein ingestion on post-exercise hypoglycaemia following resistance exercise in people with type 1 diabetes.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000716460
Enrollment
31
Registered
2025-07-07
Start date
2025-07-21
Completion date
2026-11-02
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Post-exercise hypoglycaemia is a significant challenge for individuals diagnosed with type 1 diabetes' (TID).This study will look at the effect whey protein isolate has on post-exercise glycaemic outcomes in resistance and aerobic exercise sessions, in the afternoon. This multistage block-randomised crossover study, will be conducted in roughly 31 participants whom have been diagnosed with T1D. Participants will be using an AID (Medtronic 780G hybrid closed loop (HCL) systems) and their mainstay insulin management therapy. Metabolic parameters will be tracked from exercise commencement until 0600 the next day, and various different time-intervals contained within this time period.

Interventions

For all intervention sessions pre-exercise preparations will involve a standardised meal between 30-60g of carbohydrates to be consumed roughly 4 hours prior to exercise, with standard insulin bolus regimens followed. The temporary target on the participant's device will also be set 90 minutes before exercise commencement. All intervention resistance sessions will be conducted with the first set being 40% of the participant's three repetition maximum (3RM) and the next 3 sets will be conducted

For all intervention sessions pre-exercise preparations will involve a standardised meal between 30-60g of carbohydrates to be consumed roughly 4 hours prior to exercise, with standard insulin bolus regimens followed. The temporary target on the participant's device will also be set 90 minutes before exercise commencement. All intervention resistance sessions will be conducted with the first set being 40% of the participant's three repetition maximum (3RM) and the next 3 sets will be conducted at 80% of 3RM with all reps performed at a roughly 2 second concentric and 2 second eccentric cadence. At screening individuals will participate in a 3RM strength test to determine the appropriate testing value. The main portion of the study will involve the four resistance exercise sessions which will completed by all study participants, each with varying post-exercise requirements after a 40 minute resistance exercise session and then a meal consumed 180 minutes after the completion of the resistance exercise The sessions will be completed in a randomised order for each participant. Session A, will be the control session in which just the exercise and then resultant meal will be consumed. Session B be will require the whey protein drink be consumed within 30 minutes post exercise completion. Session C will require the whey protein drink to be consumed with the post-exercise standard meal. Session D will mimic current 'best-practice' guidelines, with a 25% insulin reduction being administered at the time of the post-exercise meal. The sessions will be conducted one on one, with a study investigator and a study doctor and/or study exercise physiologist present. Sessions will be scheduled when participants are free, There will be no scheduled days for the sessions and sessions will be scheduled around when participants are free. The optional aerobic exercise sessions will choose to undertake in two additional bouts of moderate intensity exercise (MIE). Individuals will both complete session E and one of sessions Fi or Fii. Session E will involve a 40 minute MIE aerobic session with the standardised meal 180 minutes post exercise. Sessions Fi and Fii will involve the 40 min standard exercise session with a whey protein drink during the 30 minute interval post-exercise or at the time of the meal for sessions Fi and Fii respectively. The first 20 participants who opt-in to undertake the optional aerobic exercise sessions will complete 40 minutes of moderate intensity (50% of their VO2 max) aerobic exercise sessions conducted on a cycle ergometer (exercise bike). At screening individuals will participate in a VO2 max session to discover the appropriate testing value. These sessions will be conducted by a study investigator and study doctor and/or study exercise physiologist. The meal components will be specific to each participant based on their standard recommendation macronutrient and caloric intake, as determined by their clinician or diabetes educator. There will be differences between the participants as their standardised meal will be based on individual factors such as; sex, age, average physical activity, etc. As long as the insulin bolus will be administered before the meal the duration of meal consumption does not need to be within a specific time frame rather should be as per standard eating habits. It will be ensured that on the days of these exercise studies that each individual is consistent with their meal caloric and macronutrient composition. If during the exercise sessions the sensor glucose levels drop below 7.0 mmol/L, 10g of carbohydrate will be consumed by the participant and a 15 minute break will be given to allow for a rise in blood glucose. This can be conducted up to three times during the exercise session (totalling 30g of carbohydrate) before the exercise session will be re-scheduled. There must be at least 48 hours between all sessions, including the period between an individual completes the aerobic and resistance exercise sessions.

Sponsors

St Vincent's Hospital Melbourne
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Age equal or greater than 18 years; type 1 diabetes of more than 1 year duration; C-peptide negative; HbA1c < 10.0% and ability to carbohydrate count.

Exclusion criteria

Pregnancy or planned pregnancy; is taking any medications that effect glucose metabolism; dietary restriction and/or other contraindication that prevents consumption of whey protein; uncontrolled coeliac disease; eGFR <40ml/min/1.73m2; history of diabetic ketoacidosis or severe hypoglycaemia in the prior 3 months; inability to complete exercise; and major medical or psychiatric illness.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026