Type 2 Diabetes MellitusWheyGLP-1NCT01571622
Whey Protein on Posprandial Glucose, Insulin GLP-1, GIP and DPP4 in Type 2 Diabetes
A study testing Whey before Breakfast and Water before breakfast in people with Type 2 Diabetes Mellitus, run by Tel Aviv University at 1 site in Israel.
Trial summary
The aim of the present study is to examine the therapeutic effect of whey protein concentrate (WPC 80) in adult subjects with in type 2 diabetes. Whey protein will be administered before breakfast and its effects on posprandial glucose, insulin, c-peptide, intact and total GIP and GLP-1, and DPP-4 plasma levels will… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Whey before Breakfast and Water before breakfast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2012to Sep 2013
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients
- Duration of diabetes: 1-10 years
- Subjects ≥ 40 and ≤70 years of age
- Metformin therapy and all oral antidiabetic medication will be allowed
- Overweight or obese (BMI: 25 to 35 kg/m2)
- Normal liver and kidney function
- Normal thyroid function
- Read and understood the informed consent form and signed it voluntarily
Who cannot join
- Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
- Type 1 or insulin treated diabetes.
- Pregnancy or lactation
- Illicit drug abuse or alcoholism
- Subject treated with insulin or treatment with degradation-resistant GLP-1R agonists (Exendin-4) or similar and DPP4 inhibitors (Januvia)
- Subjects taking anoretic drugs
Show all 11Show fewer
- Subjects on steroid treatment
- Subjects known by the principal investigator to be unable to cooperate for any reason.
- Known hypersensitivity to milk components
- Subjects after bariatric surgery.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Whey Protein Concentrate on Postprandial Glycemic Insulin, Active and Intact GLP-1and GIP, and DPP-4 Response in Type 2 Diabetic Patients
The aim of the present study is to examine the therapeutic effect of whey protein concentrate (WPC 80) in adult subjects with in type 2 diabetes. Whey protein will be administered before breakfast and its effects on posprandial glucose, insulin, c-peptide, intact and total GIP and GLP-1, and DPP-4 plasma levels will be assessed.
Read the detailed description
Milk and dairy product consumption has been associated with lower risk of metabolic disorders and cardiovascular diseases (1). A population-based prospective study (CARDIA) revealed that dairy consumption was inversely associated with the prevalence of all components of the insulin resistance syndrome (IRS) in overweight individuals (2).
Whey accounts for about 20% of whole milk protein, while casein accounts for the rest. Whey protein is a source of bioactive components and branch chained amino acids (BCAAs) which could play a further role in the control of food intake and management of glucose metabolism, obesity and diabetes (1,3,4).
Whey protein appears to have insulinotropic and glucose lowering properties in healthy adults (6-9), and also in individuals with type 2 diabetes (10,11). The magnitude of postprandial blood glucose reduction following ingestion of whey protein is comparable to that observed with pharmaceutical interventions such as sulfonylureas (12) or nateglinide (13). These findings imply an important role for whey protein in the management of type 2 diabetes (10).
Whey protein seems to induce insulinotropic/β-cell-stimulating and glucose lowering effects via bioactive peptides generated during gastrointestinal digestion of BCAAs contained in β-lactoglobulin, the major whey protein (14).
These bioactive peptides stimulate the release of several gut hormones, especially the incretins, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), which potentiate insulin secretion from β-cells and are also associated with the control of food intake (9, 15-17). Increased plasma levels of GIP and GLP-1 have been reported following whey ingestion in patients with type 2 diabetes (10). The stimulatory effect of whey protein on GLP-1 is especially important since it has been shown that postprandial GLP-1 secretion is reduced in type 2 diabetes (18).
The bioactive peptides generated from whey protein may also serve as endogenous inhibitors of dipeptidyl peptidase-4 (DPP-4) in the proximal gut, preventing incretin (GIP and GLP-1) degradation (19, 20). Indeed, recently DPP-4 inhibitors have been found and identified in Whey protein (21). All these may reduce postprandial blood glucose levels.
Incretin action is enhanced by whey protein ingestion, possibly through incretin degradation via inhibition of DPP-4 (19,20). This is important in light of several incretin-based therapies such as continuous administration of GLP-1 (19), treatment with degradation-resistant GLP-1R agonists (Exendin-4) (15,23-25), and therapy with DPP-4 inhibitors (Sitagliptin, Liraglutide and others gliptines ) (15,23-27) all of which have lead to substantial improvements in glucose control and β-cell function in subjects with type 2 diabetes.
Whey protein stimulates GLP-1 secretion and prevents its inactivation by DPP 4. Thus, by potentiating GLP-1 secretion and enhancing its action, (15), whey protein may represent a valuable tool for treating type 2 diabetes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Whey before Breakfast, Water before breakfast
- Keywords
- Whey protein, type 2 diabetes
- 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 before BreakfastDietary supplement
After consumption of whey before breakfast samples will be taken every 30 minutes for quantification of glucose, insulin, GlP-1 and GIP
Water before breakfastDietary supplement
After water before breakfast the blood samples will be taken every 30 min for quantification of glucose, insulin, GLP-1 and GIP,
| Study group | Role | What they receive |
|---|---|---|
| Water before breakfast | Placebo comparator | Each patient will consume a high-GI breakfast (white bread). Each subject will be pretreated 30 min before breakfast with 250 ml of water Receives: Dietary Supplement: Whey before Breakfast; Dietary Supplement: Water before breakfast |
| Whey before breakfast | Experimental | Each patient will consume a high-GI breakfast (white bread). Each subject will be pretreated 30 min before breakfast with Whey Protein Concentrate (WPC 80 %) 45 gr dissolved in 250 ml of water\ Receives: Dietary Supplement: Whey before Breakfast; Dietary Supplement: Water before breakfast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose response
In all 25 subjects, the effects of whey protein ingestion posprandial glucose, will be measured. Thirty minutes prior to breakfast, subjects will preloaded with one of 2 alternatives:
- (250 ml) water
- Whey Protein Concentrate (WPC 80 %), 45 gr dissolved in 250 ml of water
Measured: During 4 hours meal challenge
Secondary outcomes (1)
Insulin GLP-1, GIP and DPP4
In all 25 subjects, the effects of whey protein on posprandial insulin, C- peptide, GIP, GLP-1, and dipeptil dipeptidase-4 (DPP-4) after standardized breakfast will be measured. Thirty minutes prior to breakfast, subjects will preloaded with one of 2 alternatives:
- (250 ml) water
- Whey Protein Concentrate (WPC 80 %), 45 gr dissolved in 250 ml of water
Measured: During 4 hours after meal challange
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionJan 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel Aviv University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela Jakubowicz, Tel Aviv University
- Investigators
- Daniela Jakubowicz, MD, Principal investigator, Diabetes Unit E. Wolfson Medical Center Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571622
- Sponsor's protocol ID
- 0175-11-WOMC
- Acronym
- WheyGLP-1
- Status last verified
- Mar 2014
- First submitted
- 3 Apr 2012
- Last updated
- 31 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jakubowicz D, Froy O, Ahren B, Boaz M, Landau Z, Bar-Dayan Y, Ganz T, Barnea M, Wainstein J. Incretin, insulinotropic and glucose-lowering effects of whey protein pre-load in type 2 diabetes: a randomised clinical trial. Diabetologia. 2014 Sep;57(9):1807-11. doi: 10.1007/s00125-014-3305-x. Epub 2014 Jul 10.
PubMed 25005331
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey Protein Concentrate on Postprandial Glycemic Insulin, Active and Intact GLP-1and GIP, and DPP-4 Response in Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT01571622
- Acronym / sponsor ID
- WheyGLP-1 / 0175-11-WOMC
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Whey protein, type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Tel Aviv UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 5 Apr 2012 (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 aim of the present study is to examine the therapeutic effect of whey protein concentrate (WPC 80) in adult subjects with in type 2 diabetes. Whey protein will be administered before breakfast and its effects on posprandial glucose, insulin, c-peptide, intact and total GIP and GLP-1, and DPP-4 plasma levels will be assessed.
Detailed description
Milk and dairy product consumption has been associated with lower risk of metabolic disorders and cardiovascular diseases (1). A population-based prospective study (CARDIA) revealed that dairy consumption was inversely associated with the prevalence of all components of the insulin resistance syndrome (IRS) in overweight individuals (2).
Whey accounts for about 20% of whole milk protein, while casein accounts for the rest. Whey protein is a source of bioactive components and branch chained amino acids (BCAAs) which could play a further role in the control of food intake and management of glucose metabolism, obesity and diabetes (1,3,4).
Whey protein appears to have insulinotropic and glucose lowering properties in healthy adults (6-9), and also in individuals with type 2 diabetes (10,11). The magnitude of postprandial blood glucose reduction following ingestion of whey protein is comparable to that observed with pharmaceutical interventions such as sulfonylureas (12) or nateglinide (13). These findings imply an important role for whey protein in the management of type 2 diabetes (10).
Whey protein seems to induce insulinotropic/β-cell-stimulating and glucose lowering effects via bioactive peptides generated during gastrointestinal digestion of BCAAs contained in β-lactoglobulin, the major whey protein (14).
These bioactive peptides stimulate the release of several gut hormones, especially the incretins, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1), which potentiate insulin secretion from β-cells and are also associated with the control of food intake (9, 15-17). Increased plasma levels of GIP and GLP-1 have been reported following whey ingestion in patients with type 2 diabetes (10). The stimulatory effect of whey protein on GLP-1 is especially important since it has been shown that postprandial GLP-1 secretion is reduced in type 2 diabetes (18).
The bioactive peptides generated from whey protein may also serve as endogenous inhibitors of dipeptidyl peptidase-4 (DPP-4) in the proximal gut, preventing incretin (GIP and GLP-1) degradation (19, 20). Indeed, recently DPP-4 inhibitors have been found and identified in Whey protein (21). All these may reduce postprandial blood glucose levels.
Incretin action is enhanced by whey protein ingestion, possibly through incretin degradation via inhibition of DPP-4 (19,20). This is important in light of several incretin-based therapies such as continuous administration of GLP-1 (19), treatment with degradation-resistant GLP-1R agonists (Exendin-4) (15,23-25), and therapy with DPP-4 inhibitors (Sitagliptin, Liraglutide and others gliptines ) (15,23-27) all of which have lead to substantial improvements in glucose control and β-cell function in subjects with type 2 diabetes.
Whey protein stimulates GLP-1 secretion and prevents its inactivation by DPP 4. Thus, by potentiating GLP-1 secretion and enhancing its action, (15), whey protein may represent a valuable tool for treating type 2 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Water before breakfast | Placebo comparator | Dietary Supplement: Whey before Breakfast, Dietary Supplement: Water before breakfastEach patient will consume a high-GI breakfast (white bread). Each subject will be pretreated 30 min before breakfast with 250 ml of water |
| Whey before breakfast | Experimental | Dietary Supplement: Whey before Breakfast, Dietary Supplement: Water before breakfastEach patient will consume a high-GI breakfast (white bread). Each subject will be pretreated 30 min before breakfast with Whey Protein Concentrate (WPC 80 %) 45 gr dissolved in 250 ml of water\ |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Type 2 diabetic patients
- Duration of diabetes: 1-10 years
- Subjects ≥ 40 and ≤70 years of age
- Metformin therapy and all oral antidiabetic medication will be allowed
- Overweight or obese (BMI: 25 to 35 kg/m2)
Key exclusion criteria (11 listed)
- Liver, heart, kidney, lung, infectious, neurological, psychiatric, immunological or neoplastic diseases.
- Type 1 or insulin treated diabetes.
- Pregnancy or lactation
- Illicit drug abuse or alcoholism
- Subject treated with insulin or treatment with degradation-resistant GLP-1R agonists (Exendin-4) or similar and DPP4 inhibitors (Januvia)
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 before BreakfastAfter consumption of whey before breakfast samples will be taken every 30 minutes for quantification of glucose, insulin, GlP-1 and GIP | Dietary supplement | Water before breakfast, Whey before breakfast |
| Water before breakfastAfter water before breakfast the blood samples will be taken every 30 min for quantification of glucose, insulin, GLP-1 and GIP, | Dietary supplement | Water before breakfast, Whey before breakfast |
Primary outcome
Glucose response
Time frame: During 4 hours meal challenge
In all 25 subjects, the effects of whey protein ingestion posprandial glucose, will be measured. Thirty minutes prior to breakfast, subjects will preloaded with one of 2 alternatives: 1. (250 ml) water 2. Whey Protein Concentrate (WPC 80 %), 45 gr dissolved in 250 ml of water
1 secondary outcome
Insulin GLP-1, GIP and DPP4
Time frame: During 4 hours after meal challange
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 31 Mar 2014.
- Derived from this study: PubMed 25005331Jakubowicz D, Froy O, Ahren B, Boaz M, Landau Z, Bar-Dayan Y, Ganz T, Barnea M, Wainstein J. Incretin, insulinotropic and glucose-lowering effects of whey protein pre-load in type 2 diabetes: a randomised clinical trial. Diabetologia. 2014 Sep;57(9):1807-11. doi: 10.1007/s00125-014-3305-x. Epub 2014 Jul 10.
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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
Diabetes Unit E. Wolfson Medical Center Tel Aviv University
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 before Breakfast and Water before breakfast in people with Type 2 Diabetes Mellitus, run by Tel Aviv University at 1 site in Israel.
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 11 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 31 Mar 2014. 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 Israel. 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?
Glucose response (time frame: During 4 hours meal challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01571622, which also lists 1 linked publication.
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 31 Mar 2014.