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Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| whey protein | Experimental | whey protein with suhoor |
|
| no whey protein | Placebo Comparator | no whey protein with suhoor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Whey protein | Dietary Supplement | Powder milk |
| |
| no Whey protein |
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia incidence rate | number of hypoglycemic events (blood glucose <70mg/dl) as detected by flash glucose monitoring | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2. | Glucose profiles as detected by flash glucose monitoring | 1 month |
| Glycemic control (HbA1c) and GMI during protein consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reem Alamoudi, MD | Ministry of National Guard Health Affairs | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdullah International Research Centre | Jeddah | Saudi Arabia |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D000067816 | Whey Proteins |
| ID | Term |
|---|---|
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011506 | Proteins |
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| Dietary Supplement |
Powder milk |
|
glucose parameters detected by flash glucose monitoring by and lab |
| 1 month |
| number of days they needed to brake the fast during each week | number of days fast broken during each week | 1 month |
| Patient preferences through questionnaire | to compare patient satisfaction | 1 month |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D000067796 | Whey |
| D008892 | Milk |
| D003611 | Dairy Products |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |