HyperglycemiaNCT02471092
The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
A study testing Skim milk products in people with Hyperglycemia and Lack of Satiety, run by University of Guelph at 1 site in Canada.
Trial summary
The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperglycemia, Lack of Satiety
- What is being tested?
- Skim milk products
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2014to Sep 2016
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 20 - 24.9 kg/m2
- Healthy as determined by screening questionnaire
- Male or Female
- Non-smoking
- Normal fasting plasma glucose (<5.5 mmol/L), but not below 3.3 mmol/L.
- Prior use of acetaminophen
Who cannot join
- Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD)
- Weight loss or weight gain of more than 5 kg during the previous 2 months
- Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid)
- Serious medical condition (ie. Renal, liver)
- Lack of appetite or skipping breakfast
- Restrained eaters as defined as having a Three Factor Eating Questionnaire-Cognitive Restraint >16
Show all 13Show fewer
- Smoking
- Reported intolerance to milk or very low consumption (< 2 servings per week) as assessed by in-person screening. Or not liking of the research foods.
- Food allergies or intolerances as well as anaphylactic or life-threatening allergies - food or otherwise
- Diabetes or other metabolic diseases that could interfere with study outcomes
- Acetaminophen, codeine or opioid allergy
- Pregnant or Breast Feeding
- Typical alcohol consumption of not more than 4 drinks per sitting
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Guelph- Human Nutraceutical Research Unit
Guelph, Ontario, N1G2W1
About this study
The purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.
Read the detailed description
- A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study.
- Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.
- Conditions
- Hyperglycemia, Lack of Satiety
- Being tested
- Skim milk products
- Keywords
- satiety, glycemia, milk protein
- Medical subject headings
- Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skim milk productsOther
Milk treatments will be served with 58g of breakfast cereal.
| Study group | Role | What they receive |
|---|---|---|
| Water Control | Placebo comparator | Skim milk products. Water and permeate control; 250mL serving. Receives: Other: Skim milk products |
| Skim Milk | Active comparator | Skim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving. Receives: Other: Skim milk products |
| High Protein Milk | Experimental | Skim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving. Receives: Other: Skim milk products |
| High Protein Milk (Modified Ratio) | Experimental | Skim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving. Receives: Other: Skim milk products |
| Skim Milk (Modified Ratio) | Experimental | Skim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving. Receives: Other: Skim milk products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)
Measured: 0-200 minutes
Secondary outcomes (2)
Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)
Measured: 0-200 minutes
Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)
Measured: at 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionSep 2016
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 HyperglycemiaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Guelph
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, Laval University
- Responsible party
- Principal investigator, Amanda Wright, Ph.D., University of Guelph
- Investigators
- Amanda J Wright, Ph.D., Principal investigator, University of Guelph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471092
- Sponsor's protocol ID
- 14JN004
- Status last verified
- Oct 2016
- First submitted
- 26 May 2015
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kung B, Turgeon SL, Vien S, Kubant R, El Khoury D, Wright AJ, Goff HD, Anderson GH. Role of Amino Acids in Blood Glucose Changes in Young Adults Consuming Cereal with Milks Varying in Casein and Whey Concentrations and Their Ratio. J Nutr. 2020 Dec 10;150(12):3103-3113. doi: 10.1093/jn/nxaa275.
PubMed 33024990
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Milk Proteins on Satiety, Food Intake and Metabolic Control (Glycemia) in Early Adulthood
- ClinicalTrials.gov ID
- NCT02471092
- Acronym / sponsor ID
- 14JN004
- Conditions
- Hyperglycemia, Lack of Satiety
- Keywords
- satiety, glycemia, milk protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of GuelphUniversity, hospital or other
- Collaborators
- University of Toronto, Laval University
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 15 Jun 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 purpose of this study is to develop and test modified milk protein products to determine the effects of amino acids on food intake, satiety, insulin secretion and glucose control by insulin-independent action in healthy adults.
Detailed description
- A total of 33 males and females will participate in the study. Capillary blood samples will be collected from all participants to measure plasma glucose over a 3.5 hour postprandial study.
- Intravenous blood samples will be collected from a subset of 12 (6 males and 6 females) participants for determination of insulin, satiety hormones, acetaminophen (gastric emptying rates), and determination of amino acid profiles.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Water Control | Placebo comparator | Other: Skim milk productsSkim milk products. Water and permeate control; 250mL serving. |
| Skim Milk | Active comparator | Other: Skim milk productsSkim milk products. Skim milk (regular 80:20 protein ratio); 250mL serving. |
| High Protein Milk | Experimental | Other: Skim milk productsSkim milk products. High protein milk (regular 80:20 protein ratio); 250mL serving. |
| High Protein Milk (Modified Ratio) | Experimental | Other: Skim milk productsSkim milk products. High protein milk with modified protein ratio (40:60 ratio); 250 mL serving. |
| Skim Milk (Modified Ratio) | Experimental | Other: Skim milk productsSkim milk products. Skim milk with modified protein ratio (40:60 ratio); 250 mL serving. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- BMI 20 - 24.9 kg/m2
- Healthy as determined by screening questionnaire
- Male or Female
- Non-smoking
- Normal fasting plasma glucose (<5.5 mmol/L), but not below 3.3 mmol/L.
Key exclusion criteria (13 listed)
- Gastrointestinal conditions or illness (including, but not limited to, lactose intolerance, Celiac, Crohn's, Ulcerative Colitis (UC), Irritable Bowel Disorder (IBD)
- Weight loss or weight gain of more than 5 kg during the previous 2 months
- Taking medication or protein supplements (excluding oral contraceptive, multivitamins and folic acid)
- Serious medical condition (ie. Renal, liver)
- Lack of appetite or skipping breakfast
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 |
|---|---|---|
| Skim milk productsMilk treatments will be served with 58g of breakfast cereal. | Other | High Protein Milk, High Protein Milk (Modified Ratio), Skim Milk, Skim Milk (Modified Ratio), Water Control |
Primary outcome
Postprandial Glycemia, as measured by capillary blood glucose (mmol/L)
Time frame: 0-200 minutes
2 secondary outcomes
Postprandial Satiety, as measured by paper 100-mm visual analogue scale (mm)
Time frame: 0-200 minutes
Food Intake at ad libitum lunch meal, as measured by weighed pizza consumption (g)
Time frame: at 120 minutes
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 25 Oct 2016.
- Derived from this study: PubMed 33024990Kung B, Turgeon SL, Vien S, Kubant R, El Khoury D, Wright AJ, Goff HD, Anderson GH. Role of Amino Acids in Blood Glucose Changes in Young Adults Consuming Cereal with Milks Varying in Casein and Whey Concentrations and Their Ratio. J Nutr. 2020 Dec 10;150(12):3103-3113. doi: 10.1093/jn/nxaa275.
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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.
Amanda J Wright, Ph.D. principal investigator
University of Guelph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skim milk products in people with Hyperglycemia and Lack of Satiety, run by University of Guelph 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 6 inclusion and 13 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 25 Oct 2016. 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. Some participants in this study may receive a placebo. 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?
Postprandial Glycemia, as measured by capillary blood glucose (mmol/L) (time frame: 0-200 minutes). 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 NCT02471092, 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 25 Oct 2016.