Type1 DiabetesNCT06595550
The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During Fasting Ramadan.
A study testing Whey protein and no Whey protein in people with Type1 Diabetes and Fasting, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
Trial summary
Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Type1 Diabetes, Fasting, Nutrition, Healthy
- What is being tested?
- Whey protein and no Whey protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Feb 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Type 1 Diabetes Mellitus
- Age >14 years
- Committed to do Regular SMBG or on CGM
- On Multiple Daily Injections or insulin pumps
- On carbohydrate counting for meal dosing
- Have previously fasted Ramadan
- willing to fast Ramadan this year
- Well-educated about requirements for fasting Ramadan
Who cannot join
- Hypoglycemia unawareness
- Cognitive impairment or learning disability
- Renal and hepatic impairment
- Adrenal insufficiency
- Pregnancy
- Alcohol consumption
Show all 10Show fewer
- Any diagnosed psychiatric disease
- Sensor-augmented insulin pumps
- HbA1c >12%
- Already on protein supplements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During the Fasting Holy Month of Ramadan: a Randomized, Crossover Study
Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan
Read the detailed 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.
- Conditions
- Type1 Diabetes, Fasting, Nutrition, Healthy
- Being tested
- Whey protein, no Whey protein
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey proteinDietary supplement
Powder milk
no Whey proteinDietary supplement
Powder milk
| Study group | Role | What they receive |
|---|---|---|
| whey protein | Experimental | whey protein with suhoor Receives: Dietary Supplement: Whey protein |
| no whey protein | Placebo comparator | no whey protein with suhoor Receives: Dietary Supplement: no Whey protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia incidence rate
number of hypoglycemic events (blood glucose <70mg/dl) as detected by flash glucose monitoring
Measured: 1 month
Secondary outcomes (4)
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
Measured: 1 month
Glycemic control (HbA1c) and GMI during protein consumption
glucose parameters detected by flash glucose monitoring by and lab
Measured: 1 month
number of days they needed to brake the fast during each week
number of days fast broken during each week
Measured: 1 month
Patient preferences through questionnaire
to compare patient satisfaction
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Feb 2023
- Primary completion30 Aug 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem Alamoudi, MD, Principal investigator, Ministry of National Guard Health Affairs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06595550
- Sponsor's protocol ID
- ICT23J/001/01
- Status last verified
- Jan 2024
- First submitted
- 2 Jan 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whey Protein Consumption on Hypoglycemia in Adults with Type 1 Diabetes During the Fasting Holy Month of Ramadan: a Randomized, Crossover Study
- ClinicalTrials.gov ID
- NCT06595550
- Acronym / sponsor ID
- ICT23J/001/01
- Conditions
- Type1 Diabetes, Fasting, Nutrition, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cross over randomized design for adding whey protein to Suhoor meal for patients with T1DM during fasting Ramadan
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| whey protein | Experimental | Dietary Supplement: Whey proteinwhey protein with suhoor |
| no whey protein | Placebo comparator | Dietary Supplement: no Whey proteinno whey protein with suhoor |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Type 1 Diabetes Mellitus
- Age >14 years
- Committed to do Regular SMBG or on CGM
- On Multiple Daily Injections or insulin pumps
- On carbohydrate counting for meal dosing
Key exclusion criteria (10 listed)
- Hypoglycemia unawareness
- Cognitive impairment or learning disability
- Renal and hepatic impairment
- Adrenal insufficiency
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whey proteinPowder milk | Dietary supplement | whey protein |
| no Whey proteinPowder milk | Dietary supplement | no whey protein |
Primary outcome
Hypoglycemia incidence rate
Time frame: 1 month
number of hypoglycemic events (blood glucose <70mg/dl) as detected by flash glucose monitoring
4 secondary outcomes
Percentage Time-below-range (TBR), time-above-range (TAR), and time-in-range (TIR) prior to and following whey protein consumption 2.
Time frame: 1 month
Glycemic control (HbA1c) and GMI during protein consumption
Time frame: 1 month
number of days they needed to brake the fast during each week
Time frame: 1 month
Patient preferences through questionnaire
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem Alamoudi, MD principal investigator
Ministry of National Guard Health Affairs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey protein and no Whey protein in people with Type1 Diabetes and Fasting, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia incidence rate (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.