HealthyOPTI-PROTNCT00712010
Metabolic Effect of High-protein Meals in Men
A study testing Whey protein native, Whey protein microgels and Hydrolyzed whey protein in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Whey protein native, Whey protein microgels and Hydrolyzed whey protein
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2008to Apr 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20 - 50 years, male
- Healthy as determined by a medical questionnaire
- Normal weight: BMI 20 - 24.9 kg.m-2
- Normal fasting glycemia and insulinemia
- Normal fasting lipidemia (cholesterol and triglycerides)
- Normal liver function (transaminases, γ-GT) and kidney function (urea, creatinine)
- Capable of fast ingestion of the meal replacement (5-10 min)
- Having signed informed consent
Who cannot join
- Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
- Hypertension >150/95 mmHg
- Have had a gastrointestinal surgery
- Have a regular consumption of medication
- Vegetarian, vegan, under dietary supplements
- Have an alcohol intake: > 2 units a day or smoker
Show all 10Show fewer
- Currently participating or having participated in a clinical trial during the last month
- Having given blood in the last month
- More than 5 x 45 min of intense exercise per week
- Volunteer who cannot be expected to comply with treatment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nestec Clinical Development Unit / Metabolic Unit
Lausanne, 1000
About this study
Official title: Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men
The purpose of the clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.
Read the detailed description
It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms.
The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.
- Conditions
- Healthy
- Being tested
- Whey protein native, Whey protein microgels, Hydrolyzed whey protein, Casein native, Hydrolyzed casein
- Keywords
- Glucose, Insulin
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey protein nativeOther
Whey protein native against the 6 other arms
Whey protein microgelsOther
Whey protein microgels versus the six other arms
Hydrolyzed whey proteinOther
versus the six other arms
Casein nativeOther
versus the six other arms
Hydrolyzed caseinOther
versus the six other arms
Total milk protein nativeOther
versus the six other arms
Hydrolyzed milk proteinOther
versus the six other arms
| Study group | Role | What they receive |
|---|---|---|
| Whey protein native | Experimental | Whey protein native versus the 6 other arms Receives: Other: Whey protein microgels; Other: Hydrolyzed whey protein; Other: Casein native; Other: Hydrolyzed casein; Other: Total milk protein native; Other: Hydrolyzed milk protein |
| Whey protein microgels | Experimental | Whey protein microgels versus the 6 other arms Receives: Other: Whey protein native; Other: Hydrolyzed whey protein; Other: Casein native; Other: Hydrolyzed casein; Other: Total milk protein native; Other: Hydrolyzed milk protein |
| Hydrolyzed whey protein | Experimental | Hydrolyzed whey protein versus the 6 other arms Receives: Other: Whey protein native; Other: Whey protein microgels; Other: Casein native; Other: Hydrolyzed casein; Other: Total milk protein native; Other: Hydrolyzed milk protein |
| Casein native | Experimental | Casein native versus the 6 other arms Receives: Other: Whey protein native; Other: Whey protein microgels; Other: Hydrolyzed whey protein; Other: Hydrolyzed casein; Other: Total milk protein native; Other: Hydrolyzed milk protein |
| Hydrolyzed casein | Experimental | Hydrolyzed casein versus the 6 other arms Receives: Other: Whey protein native; Other: Whey protein microgels; Other: Hydrolyzed whey protein; Other: Casein native; Other: Total milk protein native; Other: Hydrolyzed milk protein |
| Total milk protein native | Experimental | Total milk protein native versus the 6 other arms Receives: Other: Whey protein native; Other: Whey protein microgels; Other: Hydrolyzed whey protein; Other: Casein native; Other: Hydrolyzed casein; Other: Hydrolyzed milk protein |
| Hydrolyzed milk protein | Experimental | Hydrolyzed milk protein versus the 6 other arms Receives: Other: Whey protein native; Other: Whey protein microgels; Other: Hydrolyzed whey protein; Other: Casein native; Other: Hydrolyzed casein; Other: Total milk protein native |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-prandial Plasma Responses of Glucose Concentrations
The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
Measured: 180 minutes
Calculation of the Area Under Curve Over Baseline for Plasma Insulin
The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
Measured: 180 minutes from baseline
Secondary outcomes (1)
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionJul 2009
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, CDUadmin, Société des Produits Nestlé (SPN)
- Investigators
- Etienne Pouteau, Ph.D., Study director, Société des Produits Nestlé (SPN)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712010
- Sponsor's protocol ID
- 07.26.MET
- Other IDs
- Ethics: 71/08
- Acronym
- OPTI-PROT
- Status last verified
- Jul 2013
- First submitted
- 3 Jul 2008
- Last updated
- 14 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Metabolic Effect of the Protein Quality of a High-protein Meal Replacement in Healthy Men
- ClinicalTrials.gov ID
- NCT00712010
- Acronym / sponsor ID
- OPTI-PROT / 07.26.MET
- Conditions
- Healthy
- Keywords
- Glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Jul 2008 (estimated)
- Results
- Posted 14 Aug 2013
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 clinical study is to investigate the effect of the protein quality of high-protein meal replacements on the management of post-prandial blood glucose in healthy men.
Detailed description
It was a double-blind, single center, randomized, crossover adaptive study design with 7 arms.
The subjects were submitted to 7 tests of ingestion of a high-protein meal replacement (test meal) in randomized order preferably a week apart. The 7 test meals were isocaloric, isonitrogenous and differed in their protein quality.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Whey protein native | Experimental | Other: Whey protein microgels, Other: Hydrolyzed whey protein, Other: Casein native, Other: Hydrolyzed casein, Other: Total milk protein native, Other: Hydrolyzed milk proteinWhey protein native versus the 6 other arms |
| Whey protein microgels | Experimental | Other: Whey protein native, Other: Hydrolyzed whey protein, Other: Casein native, Other: Hydrolyzed casein, Other: Total milk protein native, Other: Hydrolyzed milk proteinWhey protein microgels versus the 6 other arms |
| Hydrolyzed whey protein | Experimental | Other: Whey protein native, Other: Whey protein microgels, Other: Casein native, Other: Hydrolyzed casein, Other: Total milk protein native, Other: Hydrolyzed milk proteinHydrolyzed whey protein versus the 6 other arms |
| Casein native | Experimental | Other: Whey protein native, Other: Whey protein microgels, Other: Hydrolyzed whey protein, Other: Hydrolyzed casein, Other: Total milk protein native, Other: Hydrolyzed milk proteinCasein native versus the 6 other arms |
| Hydrolyzed casein | Experimental | Other: Whey protein native, Other: Whey protein microgels, Other: Hydrolyzed whey protein, Other: Casein native, Other: Total milk protein native, Other: Hydrolyzed milk proteinHydrolyzed casein versus the 6 other arms |
| Total milk protein native | Experimental | Other: Whey protein native, Other: Whey protein microgels, Other: Hydrolyzed whey protein, Other: Casein native, Other: Hydrolyzed casein, Other: Hydrolyzed milk proteinTotal milk protein native versus the 6 other arms |
| Hydrolyzed milk protein | Experimental | Other: Whey protein native, Other: Whey protein microgels, Other: Hydrolyzed whey protein, Other: Casein native, Other: Hydrolyzed casein, Other: Total milk protein nativeHydrolyzed milk protein versus the 6 other arms |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 20 - 50 years, male
- Healthy as determined by a medical questionnaire
- Normal weight: BMI 20 - 24.9 kg.m-2
- Normal fasting glycemia and insulinemia
- Normal fasting lipidemia (cholesterol and triglycerides)
Key exclusion criteria (10 listed)
- Intestinal or metabolic diseases/disorders such as diabetic, renal, dyslipidemia, hepatic, hypertension, pancreatic or ulcer, including lacto-intolerance.
- Hypertension >150/95 mmHg
- Have had a gastrointestinal surgery
- Have a regular consumption of medication
- Vegetarian, vegan, under dietary supplements
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 nativeWhey protein native against the 6 other arms | Other | Casein native, Hydrolyzed casein, Hydrolyzed milk protein, Hydrolyzed whey protein, Total milk protein native, Whey protein microgels |
| Whey protein microgelsWhey protein microgels versus the six other arms | Other | Casein native, Hydrolyzed casein, Hydrolyzed milk protein, Hydrolyzed whey protein, Total milk protein native, Whey protein native |
| Hydrolyzed whey proteinversus the six other arms | Other | Casein native, Hydrolyzed casein, Hydrolyzed milk protein, Total milk protein native, Whey protein microgels, Whey protein native |
| Casein nativeversus the six other arms | Other | Hydrolyzed casein, Hydrolyzed milk protein, Hydrolyzed whey protein, Total milk protein native, Whey protein microgels, Whey protein native |
| Hydrolyzed caseinversus the six other arms | Other | Casein native, Hydrolyzed milk protein, Hydrolyzed whey protein, Total milk protein native, Whey protein microgels, Whey protein native |
| Total milk protein nativeversus the six other arms | Other | Casein native, Hydrolyzed casein, Hydrolyzed milk protein, Hydrolyzed whey protein, Whey protein microgels, Whey protein native |
| Hydrolyzed milk proteinversus the six other arms | Other | Casein native, Hydrolyzed casein, Hydrolyzed whey protein, Total milk protein native, Whey protein microgels, Whey protein native |
Primary outcome
Post-prandial Plasma Responses of Glucose Concentrations
Time frame: 180 minutes
The concentrations of glucose were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
Calculation of the Area Under Curve Over Baseline for Plasma Insulin
Time frame: 180 minutes from baseline
The concentrations of insulin were analyzed in the 10 plasma samples collected over 3 h postprandially in all subjects (Baseline, 10, 20, 30, 45, 60, 90, 120, 150, and 180 min after product intake). The Area-Under-the-Curves (AUC) over 180 minutes from baseline were calculated by trapezoidal interpolation by excluding the area under baseline.
1 secondary outcome
Post-prandial Plasma Responses of Glucagon, C-peptide, Amino Acids and Lipids
Time frame: 180 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Etienne Pouteau, Ph.D. study director
Société des Produits Nestlé (SPN)
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 protein native, Whey protein microgels and Hydrolyzed whey protein in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 10 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 14 Aug 2013. 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 Switzerland. 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?
Yes. Results are posted in the registry (first posted 14 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-prandial Plasma Responses of Glucose Concentrations (time frame: 180 minutes). The study lists 2 primary outcomes in all. 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 14 Aug 2013.