Type 2 DiabetesPBDNCT02854202
High Protein Breakfast on Postprandial Glycemia in T2D (PBD)
A study testing Arm1: Whey protein, Arm 2 Breakfast- other proteins and Arm 3 Breakfast- low protein in people with Type 2 Diabetes, run by Hospital de Clinicas Caracas.
Trial summary
The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 30 to 72 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Arm1: Whey protein, Arm 2 Breakfast- other proteins and Arm 3 Breakfast- low protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Oct 2016
- 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 30 to 72 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants: from 30 to 72 years of age
- BMI: 26 to 34 kg/m2)
- Diabetes criteria
- HbA1C: 7-9 % or
- Habitually eat breakfast
- Only naïve or treated with metformin.
- Not dieting and no change in body weight >10 lb = 4.5 kg within the last 3 months
- Normal liver, kidney and thyroid function.
Who cannot join
- Type 1 Diabetes
- Anemia (Hg > 10 g/dL)
- Serum creatinine level < 1.5 mg/dl
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
- Infectious disease
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- Pregnant women or lactating
- Known hypersensitivity to milk components
- Documented or suspected history (within one year) of illicit drug abuse or alcoholism.
About this study
Official title: Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes
The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).
Read the detailed description
It was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals This study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (PPHG) in T2D individuals.
- Conditions
- Type 2 Diabetes
- Being tested
- Arm1: Whey protein, Arm 2 Breakfast- other proteins, Arm 3 Breakfast- low protein
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arm1: Whey proteinOther
Also called WB
Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast
Arm 2 Breakfast- other proteinsOther
Also called PB
Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast
Arm 3 Breakfast- low proteinOther
Also called LP
Arm 3: Low protein' :The participants will consume 22 g protein at breakfast
| Study group | Role | What they receive |
|---|---|---|
| Arm 1-Whey protein | Experimental | In the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey Receives: Other: Arm1: Whey protein |
| Arm 2 Breakfast- other proteins | Active comparator | In the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast Receives: Other: Arm 2 Breakfast- other proteins |
| Arm 3 Breakfast- low protein | Placebo comparator | In the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast Receives: Other: Arm 3 Breakfast- low protein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma glucose
Overall postprandial glycemia after breakfast, lunch and dinner
Measured: 3 month
Secondary outcomes (2)
Satiety
Postprandial satiety after breakfast lunch and dinner, assessed with visual analog scale.
Measured: 3 month
Change in body weight
Body weight will be assessed every every two weeks during 3 month
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startAug 2012
- Primary completionDec 2014
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas Caracas
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Daniela Jakubowicz, MD, Hospital de Clinicas Caracas
- Investigators
- Daniela Jakubowicz, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854202
- Sponsor's protocol ID
- HCCBI 017-2008-112
- Acronym
- PBD
- Status last verified
- Jul 2016
- First submitted
- 31 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High Protein Breakfast on Overall Postprandial Glycemia in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02854202
- Acronym / sponsor ID
- PBD / HCCBI 017-2008-112
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital de Clinicas CaracasUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Aug 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2016 (estimated)
- First posted
- 3 Aug 2016 (estimated)
- 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.
The investigators hypothesis is that eating whey protein in breakfast will reduce overall postprandial glycemia in individuals with type 2 diabetes (T2D).
Detailed description
It was shown that increasing protein at breakfast results in reduced overall postprandial glycemia in obese individuals This study was undertaken to evaluate whether compared to proteins like tuna, eggs and soy, the intake of whey protein in the breakfast is more effective to reduce overall postprandial glycemia (PPHG) in T2D individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1-Whey protein | Experimental | Other: Arm1: Whey proteinIn the Arm 1-Whey protein Breakfast the participant will consume 42 g protein at breakfast mainly from whey |
| Arm 2 Breakfast- other proteins | Active comparator | Other: Arm 2 Breakfast- other proteinsIn the Arm 2 Breakfast- other proteins sources (No Whey) the participants will consume 42 g protein from other sources (no Whey) at breakfast |
| Arm 3 Breakfast- low protein | Placebo comparator | Other: Arm 3 Breakfast- low proteinIn the Arm 3: breakfast with low proteins content, the participant will consume 22 g protein at breakfast |
Who may qualify
- Ages
- 30 to 72 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants: from 30 to 72 years of age
- BMI: 26 to 34 kg/m2)
- Diabetes criteria
- HbA1C: 7-9 % or
- Habitually eat breakfast
Key exclusion criteria (9 listed)
- Type 1 Diabetes
- Anemia (Hg > 10 g/dL)
- Serum creatinine level < 1.5 mg/dl
- Pulmonary disease, psychiatric, immunological, neoplastic diseases or severe diabetic complications, such as cardiovascular disease, cerebrovascular disease, proliferative diabetic retinopathy, gastroparesis or underwent bariatric surgery.
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase and/or aspartate
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 |
|---|---|---|
| Arm1: Whey proteinAlso: WBArm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast | Other | Arm 1-Whey protein |
| Arm 2 Breakfast- other proteinsAlso: PBArm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast | Other | Arm 2 Breakfast- other proteins |
| Arm 3 Breakfast- low proteinAlso: LPArm 3: Low protein' :The participants will consume 22 g protein at breakfast | Other | Arm 3 Breakfast- low protein |
Primary outcome
Plasma glucose
Time frame: 3 month
Overall postprandial glycemia after breakfast, lunch and dinner
2 secondary outcomes
Satiety
Time frame: 3 month
Change in body weight
Time frame: 3 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- 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.
Daniela Jakubowicz, MD principal investigator
Wolfson Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Arm1: Whey protein, Arm 2 Breakfast- other proteins and Arm 3 Breakfast- low protein in people with Type 2 Diabetes, run by Hospital de Clinicas Caracas.
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 9 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: status not confirmed, as of the sponsor's last update on 3 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Plasma glucose (time frame: 3 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 3 Aug 2016.