Diabetes PreventionNCT00988182
The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults
A study testing dietary intervention in people with Diabetes Prevention and Obesity Prevention, run by University of Toronto at 1 site in Canada.
Trial summary
The purpose of this study is to describe relationships among whey protein and its hydrolysate when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in healthy young adults. Read more about this study
- Who is it for?
- Ages 20 to 27 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Prevention, Obesity Prevention
- What is being tested?
- dietary intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento not given
- 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 27 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- normal body weight
Who cannot join
- breakfast skippers
- smokers
- dieters or individuals with diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Toronto, Department of Nutritional Sciences
Toronto, Ontario, M5S 3E2
About this study
The purpose of this study is to describe relationships among whey protein and its hydrolysate when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in healthy young adults.
Read the detailed description
A randomized, cross-over design study was conducted. Whey protein preloads (5-40 g) and hydrolysate whey protein (10 g) were provided in 300 ml water. At 30 min following consumption, subjects were fed a preset pizza meal (12 kcal/kg, experiment 2). Satiety, insulin and blood glucose were measured at baseline and selected intervals pre- and post-meal.
- Conditions
- Diabetes Prevention, Obesity Prevention
- Being tested
- dietary intervention, water control
- Keywords
- Whey protein, Hydrolysate whey protein, Blood 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.
dietary interventionOther
whey protein
water controlOther
| Study group | Role | What they receive |
|---|---|---|
| whey protein, 5g | Experimental | Not described Receives: Other: dietary intervention |
| whey protein, 10g | Experimental | Not described Receives: Other: dietary intervention |
| whey protein, 20g | Experimental | Not described Receives: Other: dietary intervention |
| whey protein, 40g | Experimental | Not described Receives: Other: dietary intervention |
| water control | Experimental | Not described Receives: Other: water control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose, Insulin, Subjective appetite
Measured: 0-170 min
Secondary outcomes (1)
Physical comfort
Measured: 0-170 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2009 (estimated)
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 PreventionStudies of the same condition, open and under way.
- More trials run by University of TorontoThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Mondelēz International, Inc.
- Investigators
- Harvey Anderson, Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988182
- Sponsor's protocol ID
- Kraft_whey protein: study 2
- Status last verified
- Oct 2009
- First submitted
- 30 Sep 2009
- Last updated
- 2 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Akhavan T, Luhovyy BL, Brown PH, Cho CE, Anderson GH. Effect of premeal consumption of whey protein and its hydrolysate on food intake and postmeal glycemia and insulin responses in young adults. Am J Clin Nutr. 2010 Apr;91(4):966-75. doi: 10.3945/ajcn.2009.28406. Epub 2010 Feb 17.
PubMed 20164320
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whey Protein and Its Hydrolysate on Pre- and Post-Fixed Meal Glycemia and Insulin in Young Adults
- ClinicalTrials.gov ID
- NCT00988182
- Acronym / sponsor ID
- Kraft_whey protein: study 2
- Conditions
- Diabetes Prevention, Obesity Prevention
- Keywords
- Whey protein, Hydrolysate whey protein, Blood glucose, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Natural Sciences and Engineering Research Council, Canada, Mondelēz International, Inc.
- First posted
- 2 Oct 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 describe relationships among whey protein and its hydrolysate when consumed before a meal on pre- and post-fixed meal satiety, blood glucose and insulin in healthy young adults.
Detailed description
A randomized, cross-over design study was conducted. Whey protein preloads (5-40 g) and hydrolysate whey protein (10 g) were provided in 300 ml water. At 30 min following consumption, subjects were fed a preset pizza meal (12 kcal/kg, experiment 2). Satiety, insulin and blood glucose were measured at baseline and selected intervals pre- and post-meal.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| whey protein, 5g | Experimental | Other: dietary intervention |
| whey protein, 10g | Experimental | Other: dietary intervention |
| whey protein, 20g | Experimental | Other: dietary intervention |
| whey protein, 40g | Experimental | Other: dietary intervention |
| water control | Experimental | Other: water control |
Who may qualify
- Ages
- 20 to 27 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- normal body weight
Key exclusion criteria (3 listed)
- breakfast skippers
- smokers
- dieters or individuals with diabetes (fasting blood glucose ≥ 7.0 mmol/L) or other metabolic diseases
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 |
|---|---|---|
| dietary interventionwhey protein | Other | whey protein, 10g, whey protein, 20g, whey protein, 40g, whey protein, 5g |
| water control | Other | water control |
Primary outcome
Blood glucose, Insulin, Subjective appetite
Time frame: 0-170 min
1 secondary outcome
Physical comfort
Time frame: 0-170 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 2 Oct 2009.
- Derived from this study: PubMed 20164320Akhavan T, Luhovyy BL, Brown PH, Cho CE, Anderson GH. Effect of premeal consumption of whey protein and its hydrolysate on food intake and postmeal glycemia and insulin responses in young adults. Am J Clin Nutr. 2010 Apr;91(4):966-75. doi: 10.3945/ajcn.2009.28406. Epub 2010 Feb 17.
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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.
Harvey Anderson, Ph.D. principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary intervention in people with Diabetes Prevention and Obesity Prevention, run by University of Toronto at 1 site in Canada.
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 1 inclusion and 3 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 2 Oct 2009. 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 Canada. 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, Subjective appetite (time frame: 0-170 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 NCT00988182, 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 2 Oct 2009.