Diabetes Mellitus, Type 2NCT01586780
Metabolic Effects of a Pre-meal Protein Drink With or Without Added Amino Acids at a Subsequent Composite Meal
A study testing Protein drink and Reference meal in people with Diabetes Mellitus, Type 2 and Satiety Response, run by Lund University at 1 site in Sweden.
Trial summary
The purpose of the study was to investigate the efficacy of intake of whey or soy protein isolates, respectively, with or without supplementation of amino acids, on post-meal insulin secretion and glycaemic regulation. Read more about this study
- Who is it for?
- Ages 20 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Satiety Response
- What is being tested?
- Protein drink and Reference meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2009to Dec 2009
- 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 20 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal fasting blood glucose
- normal BMI
Who cannot join
- smokers
- vegetarians
- subjects who receives any drug treatment
- lactose malabsorption
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Applied Nutrition and Food Chemistry, Lund University
Lund, SE-221 00
About this study
Official title: Effects of Pre-meal Drinks With Protein and Amino Acids on Glycemic and Metabolic Responses at a Subsequent Composite Meal
The purpose of the study was to investigate the efficacy of intake of whey or soy protein isolates, respectively, with or without supplementation of amino acids, on post-meal insulin secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut hormones and ghrelin in plasma, as well as subjective satiety was investigated.
Read the detailed description
Hyperglycaemia in type 2 diabetes (T2D) is associated with an increased risk of cardiovascular diseases, and it has been suggested that reduction of postprandial glycaemia is just as important as lowering fasting blood glucose levels to reach optimal metabolic control and reduce risk of complications in T2D. Observational studies indicate that milk consumption reduces the risk of developing T2D, obesity and cardiovascular disease, and a possible protective mechanism has been ascribed to the protein fraction. It has previously been demonstrated that addition of whey proteins, co-ingested with carbohydrates, stimulates insulin secretion and reduces postprandial glycaemia in both healthy subjects as well as in T2D patients. The effect is mediated through the insulinogenic properties of whey that appears to stem from a generation of a particular amino acid (AA) pattern in postprandial blood after ingestion of whey proteins. In the presently described project it is hypothesized that exchanging part of the whey protein for insulinogenic AA might be useful to optimize an insulinogenic effect. Additionally, soy protein has been suggested to have beneficial effects on insulin resistance and obesity as well on satiety. The possible effect of soy protein on insulin response and glycaemic regulation is therefore also of interest.
A randomized, single blind, within-subject trial was performed. The test meals were provided as breakfasts on 7 different occasions in random order with approximately 1 week between each test. The test subjects were instructed to drink the protein drink immediately prior to eating the standardized sandwich meal. Altogether, the protein drink and the sandwich meal were to be consumed within 12 min.
- Conditions
- Diabetes Mellitus, Type 2, Satiety Response
- Being tested
- Protein drink, Reference meal
- Keywords
- Whey protein, Soy protein, Insulinogenic amino acids, Incretins, Glycaemia, Insulinaemia
- 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.
Protein drinkDietary supplement
Test drink providing 9g protein
Reference mealDietary supplement
Control meal
| Study group | Role | What they receive |
|---|---|---|
| Reference meal | Experimental | Not described Receives: Dietary Supplement: Reference meal |
| Whey protein | Experimental | Not described Receives: Dietary Supplement: Protein drink |
| Whey + 5 amino acids | Experimental | Not described Receives: Dietary Supplement: Protein drink |
| Whey + 6 amino acids | Experimental | Not described Receives: Dietary Supplement: Protein drink |
| Soy protein drink | Experimental | Not described Receives: Dietary Supplement: Protein drink |
| Soy + 5 amino acids | Experimental | Not described Receives: Dietary Supplement: Protein drink |
| Soy + 6 amino acids | Experimental | Not described Receives: Dietary Supplement: Protein drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose, insulin, amino acids, ghrelin and incretins
Measured: Acute postprandial phase (0-180 min)
Secondary outcomes (1)
Subjective satiety
Measured: 3h postprandial (0-180 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2012 (estimated)
- Study startAug 2009
- Primary completionDec 2009
- Study completionDec 2009
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 Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrika Gunnerud, Lund University
- Investigators
- Inger Björck, Professor, Study chair, Lund UniversityUlrika Gunnerud, MSc, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01586780
- Sponsor's protocol ID
- Dnr 1.556/2008
- Status last verified
- Apr 2012
- First submitted
- 23 Apr 2012
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Gunnerud UJ, Heinzle C, Holst JJ, Ostman EM, Bjorck IM. Effects of pre-meal drinks with protein and amino acids on glycemic and metabolic responses at a subsequent composite meal. PLoS One. 2012;7(9):e44731. doi: 10.1371/journal.pone.0044731. Epub 2012 Sep 19.
PubMed 23028596
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Pre-meal Drinks With Protein and Amino Acids on Glycemic and Metabolic Responses at a Subsequent Composite Meal
- ClinicalTrials.gov ID
- NCT01586780
- Acronym / sponsor ID
- Dnr 1.556/2008
- Conditions
- Diabetes Mellitus, Type 2, Satiety Response
- Keywords
- Whey protein, Soy protein, Insulinogenic amino acids, Incretins, Glycaemia, Insulinaemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 27 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 purpose of the study was to investigate the efficacy of intake of whey or soy protein isolates, respectively, with or without supplementation of amino acids, on post-meal insulin secretion and glycaemic regulation. Additionally, the effect on plasma amino acids, gut hormones and ghrelin in plasma, as well as subjective satiety was investigated.
Detailed description
Hyperglycaemia in type 2 diabetes (T2D) is associated with an increased risk of cardiovascular diseases, and it has been suggested that reduction of postprandial glycaemia is just as important as lowering fasting blood glucose levels to reach optimal metabolic control and reduce risk of complications in T2D. Observational studies indicate that milk consumption reduces the risk of developing T2D, obesity and cardiovascular disease, and a possible protective mechanism has been ascribed to the protein fraction. It has previously been demonstrated that addition of whey proteins, co-ingested with carbohydrates, stimulates insulin secretion and reduces postprandial glycaemia in both healthy subjects as well as in T2D patients. The effect is mediated through the insulinogenic properties of whey that appears to stem from a generation of a particular amino acid (AA) pattern in postprandial blood after ingestion of whey proteins. In the presently described project it is hypothesized that exchanging part of the whey protein for insulinogenic AA might be useful to optimize an insulinogenic effect. Additionally, soy protein has been suggested to have beneficial effects on insulin resistance and obesity as well on satiety. The possible effect of soy protein on insulin response and glycaemic regulation is therefore also of interest.
A randomized, single blind, within-subject trial was performed. The test meals were provided as breakfasts on 7 different occasions in random order with approximately 1 week between each test. The test subjects were instructed to drink the protein drink immediately prior to eating the standardized sandwich meal. Altogether, the protein drink and the sandwich meal were to be consumed within 12 min.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Reference meal | Experimental | Dietary Supplement: Reference meal |
| Whey protein | Experimental | Dietary Supplement: Protein drink |
| Whey + 5 amino acids | Experimental | Dietary Supplement: Protein drink |
| Whey + 6 amino acids | Experimental | Dietary Supplement: Protein drink |
| Soy protein drink | Experimental | Dietary Supplement: Protein drink |
| Soy + 5 amino acids | Experimental | Dietary Supplement: Protein drink |
| Soy + 6 amino acids | Experimental | Dietary Supplement: Protein drink |
Who may qualify
- Ages
- 20 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- normal fasting blood glucose
- normal BMI
Key exclusion criteria (4 listed)
- smokers
- vegetarians
- subjects who receives any drug treatment
- lactose malabsorption
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 |
|---|---|---|
| Protein drinkTest drink providing 9g protein | Dietary supplement | Soy + 5 amino acids, Soy + 6 amino acids, Soy protein drink, Whey + 5 amino acids, Whey + 6 amino acids, Whey protein |
| Reference mealControl meal | Dietary supplement | Reference meal |
Primary outcome
Blood glucose, insulin, amino acids, ghrelin and incretins
Time frame: Acute postprandial phase (0-180 min)
1 secondary outcome
Subjective satiety
Time frame: 3h postprandial (0-180 min)
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 27 Apr 2012.
- Derived from this study: PubMed 23028596Gunnerud UJ, Heinzle C, Holst JJ, Ostman EM, Bjorck IM. Effects of pre-meal drinks with protein and amino acids on glycemic and metabolic responses at a subsequent composite meal. PLoS One. 2012;7(9):e44731. doi: 10.1371/journal.pone.0044731. Epub 2012 Sep 19.
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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.
Inger Björck, Professor study chair
Lund University
Ulrika Gunnerud, MSc principal investigator
Lund 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 Protein drink and Reference meal in people with Diabetes Mellitus, Type 2 and Satiety Response, run by Lund University at 1 site in Sweden.
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 2 inclusion and 4 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 27 Apr 2012. 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 Sweden. 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?
Blood glucose, insulin, amino acids, ghrelin and incretins (time frame: Acute postprandial phase (0-180 min)). 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 NCT01586780, 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 27 Apr 2012.