InsulinNCT01034241
Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning
A study testing High dairy protein, vegetable protein and High GI in people with Insulin and Glucose Metabolism, run by Maastricht University Medical Center.
Trial summary
The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Insulin, Glucose Metabolism
- What is being tested?
- High dairy protein, vegetable protein and High GI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Mar 2010
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 18.5-25 kg/m2 (lean)
- Gender: Male
- Age: <35 years
- Caucasian
Who cannot join
- Elevated fasting blood glucose level
- Lactose intolerant
- Diabetes Mellitus
- Hypertension (systolic/diastolic blood pressure)
- Hypotension (systolic/diastolic blood pressure)
- Cardiovascular diseases
- Asthma and other obstructive pulmonary diseases
About this study
The purpose of this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.
- Conditions
- Insulin, Glucose Metabolism
- Being tested
- Control, High dairy protein, vegetable protein, High GI
- Keywords
- milk protein, overweight, insulin metabolism, substrate partitioning
- Medical subject headings
- Insulin Resistance, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Diet consists of 15 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
High dairy proteinDietary supplement
Diet consists of 25 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat
vegetable proteinDietary supplement
Diet consists of 15 En% vegetable protein and low GI, 55 En% carbohydrates and 30 En% fat
High GIDietary supplement
Diet consists of 15 En% dairy protein and high GI, 55 En% carbohydrates and 30 En% fat
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Diet consists of 15% dairy protein and low Glycemic Index (GI < 40), 55 En% carbohydrates and 30 En% fat Receives: Dietary Supplement: Control |
| High dairy protein | Experimental | Diet consists of 25% dairy protein and low GI (GI < 40), 45 En% carbohydrates and 30 En% fat Receives: Dietary Supplement: High dairy protein |
| vegetable protein | Experimental | Diet consists of 15 En% vegetable protein and low GI (GI < 40), 55 En% carbohydrates and 30 En% fat Receives: Dietary Supplement: vegetable protein |
| High GI | Experimental | Diet consists of 15 En% dairy protein and high GI(GI > 60, 55 En% carbohydrates and 30 En% fat Receives: Dietary Supplement: High GI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose and insulin metabolism (24 h)
Measured: 24 h
Secondary outcomes (1)
Substrate partitioning and metabolic markers
Measured: 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2010
- Study completionMar 2010
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 InsulinStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Nederlandse Zuivel Organisatie
- Responsible party
- Sponsor
- Investigators
- Wim Saris, Prof. Dr., Principal investigator, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01034241
- Sponsor's protocol ID
- MEC 08-3-072
- Status last verified
- Aug 2018
- First submitted
- 16 Dec 2009
- Last updated
- 23 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Munsters MJ, Geraedts MC, Saris WH. Effects of different protein and glycemic index diets on metabolic profiles and substrate partitioning in lean healthy males. Appl Physiol Nutr Metab. 2013 Nov;38(11):1107-14. doi: 10.1139/apnm-2012-0409. Epub 2013 Apr 25.
PubMed 24053517
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Protein Diets on Glucose and Insulin Metabolism and Substrate Partitioning
- ClinicalTrials.gov ID
- NCT01034241
- Acronym / sponsor ID
- MEC 08-3-072
- Conditions
- Insulin, Glucose Metabolism
- Keywords
- milk protein, overweight, insulin metabolism, substrate partitioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Nederlandse Zuivel Organisatie
- Study start
- Apr 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 17 Dec 2009 (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 this study is to determine whether different protein diets affects glucose and insulin metabolism and substrate partitioning.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: ControlDiet consists of 15% dairy protein and low Glycemic Index (GI < 40), 55 En% carbohydrates and 30 En% fat |
| High dairy protein | Experimental | Dietary Supplement: High dairy proteinDiet consists of 25% dairy protein and low GI (GI < 40), 45 En% carbohydrates and 30 En% fat |
| vegetable protein | Experimental | Dietary Supplement: vegetable proteinDiet consists of 15 En% vegetable protein and low GI (GI < 40), 55 En% carbohydrates and 30 En% fat |
| High GI | Experimental | Dietary Supplement: High GIDiet consists of 15 En% dairy protein and high GI(GI > 60, 55 En% carbohydrates and 30 En% fat |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI: 18.5-25 kg/m2 (lean)
- Gender: Male
- Age: <35 years
- Caucasian
Key exclusion criteria (7 listed)
- Elevated fasting blood glucose level
- Lactose intolerant
- Diabetes Mellitus
- Hypertension (systolic/diastolic blood pressure)
- Hypotension (systolic/diastolic blood pressure)
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 |
|---|---|---|
| ControlDiet consists of 15 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat | Dietary supplement | Control |
| High dairy proteinDiet consists of 25 En% dairy protein and low GI, 55 En% carbohydrates and 30 En% fat | Dietary supplement | High dairy protein |
| vegetable proteinDiet consists of 15 En% vegetable protein and low GI, 55 En% carbohydrates and 30 En% fat | Dietary supplement | vegetable protein |
| High GIDiet consists of 15 En% dairy protein and high GI, 55 En% carbohydrates and 30 En% fat | Dietary supplement | High GI |
Primary outcome
Glucose and insulin metabolism (24 h)
Time frame: 24 h
1 secondary outcome
Substrate partitioning and metabolic markers
Time frame: 24 h
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 23 Aug 2018.
- Derived from this study: PubMed 24053517Munsters MJ, Geraedts MC, Saris WH. Effects of different protein and glycemic index diets on metabolic profiles and substrate partitioning in lean healthy males. Appl Physiol Nutr Metab. 2013 Nov;38(11):1107-14. doi: 10.1139/apnm-2012-0409. Epub 2013 Apr 25.
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Healthy Volunteer
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.
Wim Saris, Prof. Dr. principal investigator
Maastricht University
Questions about this trial
What is this clinical trial studying?
A study testing High dairy protein, vegetable protein and High GI in people with Insulin and Glucose Metabolism, run by Maastricht University Medical 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 4 inclusion and 7 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 23 Aug 2018. 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?
Glucose and insulin metabolism (24 h) (time frame: 24 h). 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 NCT01034241, 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 23 Aug 2018.