Type 2 DiabetesWHEY-T2DNCT01944449
Effects of Whey Protein in Type 2 Diabetics
A study testing Whey Protein (WPC) at breakfast, Other Protein Sources at breakfast and Low Protein at breakfast in people with Type 2 Diabetes, run by Tel Aviv University at 2 sites in 2 countries.
Trial summary
The objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG). Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Whey Protein (WPC) at breakfast, Other Protein Sources at breakfast and Low Protein at breakfast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2013to Mar 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes patients
- HbA1C > 7.5%
- Duration of diabetes: < 20 years
- Subjects ≥ 30 and ≤70 years of age
- BMI: 22 to 35 kg/m2
- All oral antidiabetic treatments will be allowed. No insulin
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- Normal liver and kidney function
- Normal thyroid function
- Stable physical activity pattern during the three months immediately preceding study
- No metabolic disease other than diabetes
- Normal TSH and FT4 levels
- Acceptable health beside diabetes based on interview, medical history, physical examination, and laboratory tests
- Read and understood the informed consent form and signed it voluntarily
Who cannot join
- Type 1 diabetes
- Treatment with Insulin
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
- Pregnancy or lactation
- Illicit drug abuse or alcoholism
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- Subjects taking anoretic drugs during the month immediately prior to study
- Subjects on steroid treatment
- Those with major illnesses, liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases,
- Those with eating disorders
- Known hypersensitivity to milk components
- Subjects after bariatric surgery, will be excluded
- Subjects known by the principal investigator to be unable to cooperate for any reason.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
The objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG).
Read the detailed description
Whey protein that accounts for 20% of whole milk protein seems to induce insulinotropic /β-cell-stimulating and glucose lowering effects via bioactive peptides generated during its gastrointestinal digestion. These bioactive peptides stimulate the release of GLP-1, serve as endogenous inhibitors of DPP-4 and cause inhibitory activity against α-glucosidase activity, which might be an additional mechanism accounting for the glucose lowering effects of Whey.
In the investigators previous study, the acute administration with Whey protein resulted in postprandial insulinotropic and glucose lowering effects in type 2 diabetic subjects. This was associated with increased postprandial response of the total-GLP-1 and of intact-GLP-1, suggesting that the peptides generated from Whey protein may have dual beneficial effects (increasing incretin production and decreasing incretin degradation by DPP-4) on glycemia regulation in subjects with type 2 diabetes.
Addition of Whey protein to the meal, significantly decreased PPG in healthy and in type 2 diabetic subjects and there are also clinical evidence in non-diabetics individuals, that acute and chronic administration of Whey protein has antihypertensive activity.
The effect of chronic administration of Whey protein on HbA1c and PPG have not been examined previously in type 2 diabetics.
- Conditions
- Type 2 Diabetes
- Being tested
- Whey Protein (WPC) at breakfast, Other Protein Sources at breakfast, Low Protein at breakfast
- Keywords
- Type 2 diabetes (T2D), Whey Protein Concentrate (WPC)
- 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.
Whey Protein (WPC) at breakfastDietary supplement
Also called WBdiet
The type 2 diabetic subjects in Whey Protein (WPC) group will consume at breakfast WPC (35 g) in 250ml of milk, Total 42 g protein breakfast for 12 weeks.
Other Protein Sources at breakfastDietary supplement
Also called PBdiet
The type 2 diabetic subjects in PBdiet will consume also 42 g of protein but from different sources : i.e soy,tuna, eggs, at breakfast in bottle mixed with 250 ml water twice a day (30 min before breakfast and before dinner) for 12 weeks.
Low Protein at breakfastDietary supplement
Also called CBdiet
The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Whey Protein (WPC) at breakfast | Experimental | The subjects in Whey Protein (WPC) group will consume WPC (35gr) powder in bottles mixed with 250 ml milk, making a total of 42 g protein, at breakfast, for 12 weeks. Receives: Dietary Supplement: Whey Protein (WPC) at breakfast |
| Other Protein Sources at breakfast | Experimental | The subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks. Receives: Dietary Supplement: Other Protein Sources at breakfast |
| Low Protein at breakfast | Active comparator | The subjects will consume 17 g protein breakfast namely from soy for 12 weeks. Receives: Dietary Supplement: Low Protein at breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting circulating levels of HbA1c
In all 60 subjects we will evaluate at baseline and after three month of consumption of WPC or Protein from other source or Low Protein at breakfast the effects on fasting circulating levels of HbA1c.
Measured: 3 month
Secondary outcomes (2)
Postprandial Glucose
In all 60 subjects we will evaluate the effect of consumption of WPC or Protein from other source or Low Protein at breakfast on postprandial glucose
Measured: 3 month
Body Weight
In all 60 subjects we will evaluate at baseline and after three month of consumption of WPC or Protein from other source or Low Protein at breakfast the effects on body weight
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionFeb 2016
- Study completionMar 2016
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 (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital de Clinicas Caracas
- Responsible party
- Principal investigator, Daniela Jakubowicz, Hospital de Clinicas Caracas
- Investigators
- Julio Wainstein, MD, Principal investigator, Head of Diabetes Unit E. Wolfson Medical Center IsraelDaniela Jakubowicz, MD, Principal investigator, Hospital de Clinicas Caracas, Venezuela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944449
- Sponsor's protocol ID
- HCCCBI 057-2011-165
- Acronym
- WHEY-T2D
- Status last verified
- Jan 2016
- First submitted
- 2 Sep 2013
- Last updated
- 11 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Administration of Whey Protein on HbA1c and Postprandial Glycemia in Type 2 Diabetic Individuals
- ClinicalTrials.gov ID
- NCT01944449
- Acronym / sponsor ID
- WHEY-T2D / HCCCBI 057-2011-165
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes (T2D), Whey Protein Concentrate (WPC)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Collaborators
- Hospital de Clinicas Caracas
- Study start
- Sep 2013 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 17 Sep 2013 (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 objectives of this study are to examine the effects of chronic, (12 weeks) administration of Whey protein on HbA1c, and postprandial glucose (PPG).
Detailed description
Whey protein that accounts for 20% of whole milk protein seems to induce insulinotropic /β-cell-stimulating and glucose lowering effects via bioactive peptides generated during its gastrointestinal digestion. These bioactive peptides stimulate the release of GLP-1, serve as endogenous inhibitors of DPP-4 and cause inhibitory activity against α-glucosidase activity, which might be an additional mechanism accounting for the glucose lowering effects of Whey.
In the investigators previous study, the acute administration with Whey protein resulted in postprandial insulinotropic and glucose lowering effects in type 2 diabetic subjects. This was associated with increased postprandial response of the total-GLP-1 and of intact-GLP-1, suggesting that the peptides generated from Whey protein may have dual beneficial effects (increasing incretin production and decreasing incretin degradation by DPP-4) on glycemia regulation in subjects with type 2 diabetes.
Addition of Whey protein to the meal, significantly decreased PPG in healthy and in type 2 diabetic subjects and there are also clinical evidence in non-diabetics individuals, that acute and chronic administration of Whey protein has antihypertensive activity.
The effect of chronic administration of Whey protein on HbA1c and PPG have not been examined previously in type 2 diabetics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey Protein (WPC) at breakfast | Experimental | Dietary Supplement: Whey Protein (WPC) at breakfastThe subjects in Whey Protein (WPC) group will consume WPC (35gr) powder in bottles mixed with 250 ml milk, making a total of 42 g protein, at breakfast, for 12 weeks. |
| Other Protein Sources at breakfast | Experimental | Dietary Supplement: Other Protein Sources at breakfastThe subjects will consume also 42 g protein at breakfast but from different source, for 12 weeks. |
| Low Protein at breakfast | Active comparator | Dietary Supplement: Low Protein at breakfastThe subjects will consume 17 g protein breakfast namely from soy for 12 weeks. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Type 2 diabetes patients
- HbA1C > 7.5%
- Duration of diabetes: < 20 years
- Subjects ≥ 30 and ≤70 years of age
- BMI: 22 to 35 kg/m2
Key exclusion criteria (13 listed)
- Type 1 diabetes
- Treatment with Insulin
- Clinically significant pulmonary, cardiac, renal, hepatic, neurologic, psychiatric, infectious, malignant disease
- Abnormal liver function tests defined as an increase by a factor of at least 2 above the upper normal limit of alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)
- Pregnancy or lactation
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 Protein (WPC) at breakfastAlso: WBdietThe type 2 diabetic subjects in Whey Protein (WPC) group will consume at breakfast WPC (35 g) in 250ml of milk, Total 42 g protein breakfast for 12 weeks. | Dietary supplement | Whey Protein (WPC) at breakfast |
| Other Protein Sources at breakfastAlso: PBdietThe type 2 diabetic subjects in PBdiet will consume also 42 g of protein but from different sources : i.e soy,tuna, eggs, at breakfast in bottle mixed with 250 ml water twice a day (30 min before breakfast and before dinner) for 12 weeks. | Dietary supplement | Other Protein Sources at breakfast |
| Low Protein at breakfastAlso: CBdietThe type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks. | Dietary supplement | Low Protein at breakfast |
Primary outcome
Fasting circulating levels of HbA1c
Time frame: 3 month
In all 60 subjects we will evaluate at baseline and after three month of consumption of WPC or Protein from other source or Low Protein at breakfast the effects on fasting circulating levels of HbA1c.
2 secondary outcomes
Postprandial Glucose
Time frame: 3 month
Body Weight
Time frame: 3 months
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 11 Oct 2017.
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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.
Julio Wainstein, MD principal investigator
Head of Diabetes Unit E. Wolfson Medical Center Israel
Daniela Jakubowicz, MD principal investigator
Hospital de Clinicas Caracas, Venezuela
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein (WPC) at breakfast, Other Protein Sources at breakfast and Low Protein at breakfast in people with Type 2 Diabetes, run by Tel Aviv University at 2 sites in 2 countries.
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 13 inclusion and 13 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 11 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel, Venezuela. 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. 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?
Fasting circulating levels of HbA1c (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 11 Oct 2017.