The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.

King Abdullah International Medical Research Center

Status: Completed

Conditions: Type1 Diabetes; Nutrition, Healthy; Fasting

Treatments: Dietary Supplement: Whey protein; Dietary Supplement: no Whey protein

Study type: Interventional

Funder types: Other

Identifiers

NCT06595550

ICT23J/001/01

Details and patient eligibility

About

Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan

Full description

Patients with type1 diabetes who intend to fast will be supplied with dietary supplement "Whey protein" to be taken with Suhoor (predawn meal) for one week during Ramadan. They will be then crossed over to not taking the whey protein for another week. the order of taking whey protein will be randomized.

During both weeks patients will be monitored through flash continuous glucose monitoring and data will be compared in regards to incidence and timing of hypoglycemia, hyperglycemia, and time in target range.

After Ramadan data will be collected on number of days they had to brake fast due to low blood sugar during both weeks and overall satisfaction with using whey protein during Ramadan.

Enrollment: 44 patients

Sex: All

Ages: 14 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Type 1 Diabetes Mellitus
2. Age >14 years
3. Committed to do Regular SMBG or on CGM
4. On Multiple Daily Injections or insulin pumps
5. On carbohydrate counting for meal dosing
6. Have previously fasted Ramadan
7. willing to fast Ramadan this year
8. Well-educated about requirements for fasting Ramadan

Exclusion criteria

1. Hypoglycemia unawareness
2. Cognitive impairment or learning disability
3. Renal and hepatic impairment
4. Adrenal insufficiency
5. Pregnancy
6. Alcohol consumption
7. Any diagnosed psychiatric disease
8. Sensor-augmented insulin pumps
9. HbA1c >12%
10. Already on protein supplements

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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44 participants in 2 patient groups, including a placebo group

whey protein

Experimental group

Description:

whey protein with suhoor

Treatment:

Dietary Supplement: Whey protein

no whey protein

Placebo Comparator group

Description:

no whey protein with suhoor

Treatment:

Dietary Supplement: no Whey protein