Whole Body Glucose and Insulin MetabolismNPSNCT02413671
The Role of Whey and Lupin in Glycemic Control (Nutritional Pre-Study)
A study testing Lupin Protein, Whey Protein and Reference in people with Whole Body Glucose and Insulin Metabolism, run by DLR German Aerospace Center.
Trial summary
The study compared the acute effects of the supplementation of a standardized meal with either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Whole Body Glucose and Insulin Metabolism
- What is being tested?
- Lupin Protein, Whey Protein and Reference
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Jun 2013to Jul 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female and male volunteers
- Age: between 20 and 45 years
- Body mass index (BMI): 20-28 kg/m²
- Fasting blood glucose within normal ranges (70-99 mg/dl; 29-42 mmol/mol Hb)
- Glycated hemoglobin HbA1c within normal ranges (4-6%)
- Agreement and signed informed consent before the study
Who cannot join
- Diabetes mellitus
- Increased bleeding tendency (hemophilia, regular use of anticoagulants)
- Allergy to nuts, legume or milk protein
- Drug, medication or alcohol abuse (frequent consumption of more than 20-30g alcohol/day)
- Intake of medication during the study
- Smoker
Show all 9Show fewer
- Competitive athletes
- Extreme eating habits (vegan, special diets)
- Any other condition classed as unsuitable by the executive medical director
About this study
Official title: Short-term Effects of Lupin Versus Whey Protein on Glucose and Insulin Responses to a Standardized Meal in a Randomized Controlled Trial
The study compared the acute effects of the supplementation of a standardized meal with either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.
Read the detailed description
The nutritional pre-study had the following key objectives:
Primary objective:
- Lupin protein lowers the postprandial blood glucose level equivalent to or to a greater extent than whey protein.
Secondary objective:
- Lupin protein has an equivalent or a stronger insulinotropic effect than whey protein.
- Being tested
- Lupin Protein, Whey Protein, Reference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lupin ProteinDietary supplement
Subjects received a standardized test meal rich in carbohydrates and supplemented with lupin protein.
Whey ProteinDietary supplement
Subjects received a standardized test meal rich in carbohydrates and supplemented with whey protein.
ReferenceOther
Subjects received a standardized test meal rich in carbohydrates and not supplemented with any protein.
| Study group | Role | What they receive |
|---|---|---|
| Lupin Protein | Other | Subjects received a test meal rich in carbohydrates and supplemented with lupin protein. Receives: Dietary Supplement: Lupin Protein |
| Whey Protein | Other | Subjects received a test meal rich in carbohydrates and supplemented with whey protein. Receives: Dietary Supplement: Whey Protein |
| Reference | Other | Subjects received a test meal rich in carbohydrates not supplemented with any protein. Receives: Other: Reference |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose Metabolism by Blood Glucose and Serum Insulin (composite)
Measured: up to 180 minutes after the test meal was finished
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Whole Body Glucose and Insulin MetabolismStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- DLR German Aerospace Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jörn Rittweger, Prof. Dr., Study director, DLR German Aerospace CenterAnn-Charlotte Ewald, Principal investigator, DLR German Aerospace CenterKathrin Schopen, M.Sc., Principal investigator, DLR German Aerospace CenterPetra Frings-Meuthen, Dr., Principal investigator, DLR German Aerospace Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413671
- Sponsor's protocol ID
- NPS
- Acronym
- NPS
- Status last verified
- Oct 2016
- First submitted
- 24 Mar 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short-term Effects of Lupin Versus Whey Protein on Glucose and Insulin Responses to a Standardized Meal in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02413671
- Acronym / sponsor ID
- NPS / NPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- DLR German Aerospace CenterUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 10 Apr 2015 (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 study compared the acute effects of the supplementation of a standardized meal with either lupin or whey protein or no protein on the whole-body glucose and insuline metabolism.
Detailed description
The nutritional pre-study had the following key objectives:
Primary objective:
- Lupin protein lowers the postprandial blood glucose level equivalent to or to a greater extent than whey protein.
Secondary objective:
- Lupin protein has an equivalent or a stronger insulinotropic effect than whey protein.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lupin Protein | Other | Dietary Supplement: Lupin ProteinSubjects received a test meal rich in carbohydrates and supplemented with lupin protein. |
| Whey Protein | Other | Dietary Supplement: Whey ProteinSubjects received a test meal rich in carbohydrates and supplemented with whey protein. |
| Reference | Other | Other: ReferenceSubjects received a test meal rich in carbohydrates not supplemented with any protein. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female and male volunteers
- Age: between 20 and 45 years
- Body mass index (BMI): 20-28 kg/m²
- Fasting blood glucose within normal ranges (70-99 mg/dl; 29-42 mmol/mol Hb)
- Glycated hemoglobin HbA1c within normal ranges (4-6%)
Key exclusion criteria (9 listed)
- Diabetes mellitus
- Increased bleeding tendency (hemophilia, regular use of anticoagulants)
- Allergy to nuts, legume or milk protein
- Drug, medication or alcohol abuse (frequent consumption of more than 20-30g alcohol/day)
- Intake of medication during the study
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 |
|---|---|---|
| Lupin ProteinSubjects received a standardized test meal rich in carbohydrates and supplemented with lupin protein. | Dietary supplement | Lupin Protein |
| Whey ProteinSubjects received a standardized test meal rich in carbohydrates and supplemented with whey protein. | Dietary supplement | Whey Protein |
| ReferenceSubjects received a standardized test meal rich in carbohydrates and not supplemented with any protein. | Other | Reference |
Primary outcome
Blood Glucose Metabolism by Blood Glucose and Serum Insulin (composite)
Time frame: up to 180 minutes after the test meal was finished
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 13 Oct 2016.
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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.
Jörn Rittweger, Prof. Dr. study director
DLR German Aerospace Center
Ann-Charlotte Ewald principal investigator
DLR German Aerospace Center
Kathrin Schopen, M.Sc. principal investigator
DLR German Aerospace Center
Questions about this trial
What is this clinical trial studying?
A study testing Lupin Protein, Whey Protein and Reference in people with Whole Body Glucose and Insulin Metabolism, run by DLR German Aerospace Center.
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 6 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: finished, as of the sponsor's last update on 13 Oct 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. 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 Metabolism by Blood Glucose and Serum Insulin (composite) (time frame: up to 180 minutes after the test meal was finished). 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 13 Oct 2016.