DiabetesPhase 1/2NCT02607007
The Effect of Dairy and Non-dairy Breakfasts on Satiety and Post-meal Glycemia in Healthy Older Adults
A Phase 1/2 study testing 2% M.F. Milk, White Bread and Strawberry Jam in people with Diabetes and Obesity, run by University of Toronto at 1 site in Canada.
Trial summary
This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt, cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each participant will receive every treatment in this crossover design study. Read more about this study
- Who is it for?
- Ages 60 to 70 yearsHealthy volunteers can take part
- What is being tested?
- 2% M.F. Milk, White Bread and Strawberry Jam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Jan 2016
- Phase
- Phase 1/2
- 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 60 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy BMI (18.5-30.0 kg/m2)
- Regular breakfast consumers
- Menopausal for at least 1 year (females)
Who cannot join
- Smoking
- Diabetes
- Fasting blood glucose equal to or higher than 6.0 mmol/L
- Cardiovascular disease
- Medication affecting appetite or metabolism
- Trying to lose or gain weight through a diet or exercise regime
- Lactose intolerance or allergies to study foods
- Score equal to or higher than 11 on Eating Habits Questionnaire
Trial locations and contacts
1 site in 1 country.
Canada1 site
Department of Nutritional Sciences, University of Toronto
Toronto, Ontario, M5S 3E2
About this study
Official title: The Effect of Dairy and Non-dairy Breakfasts on Subjective Appetite Ratings, Food Intake, and Post-meal Glycemia in Healthy Older Adults
This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt, cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each participant will receive every treatment in this crossover design study.
Read the detailed description
Regular consumption of dairy is associated with better body composition and lower incidences of type 2 diabetes and obesity. This may be due to dairy's ability to increase satiety and decrease post-prandial glycemia. However, most clinical studies have only investigated isolated dairy proteins (whey and casein) and the effects of whole dairy products, consumed as part of a meal, remain unclear. Additionally, the effect of dairy type and form remain to be further investigated. Therefore, this study will test the effects of dairy products when consumed with a high glycemic index breakfast on satiety and post-prandial glycemia.
Thirty healthy older males and females (60-70 years, BMI 18.5-30.0 kg/m2) will be recruited for the randomized, unblinded, crossover study. Participants will fast overnight, and at baseline will consume 1) 2% milk (250 mL), 2) soy beverage (250 mL), 3) plain 2% Greek yogurt (175 g), 4) cheddar cheese (30 g), or 5) water (250 mL - control). Treatments will be consumed along with 2 pieces of white toast with strawberry jam, except for the water control which will be consumed alone. All breakfast meals will be isocaloric and water will be given with the yogurt (75 mL) and cheese (220 mL) to compensate for fluid content. At 0 (baseline), 15, 30, 45, 60, 90, 120, 150, 180, (pre-meal period) and 210 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes. Between 180-200 minutes, an ad libitum lunch will be provided to assess food intake.
- Being tested
- 2% M.F. Milk, White Bread, Strawberry Jam, 31% M.F. Cheddar Cheese, 2% M.F. Plain Greek yogurt
- Keywords
- Dairy, Post-prandial Glycemia, Satiety, Food Intake, Insulin, Milk, Greek yogurt, Cheese, Soy beverage
- Medical subject headings
- Diabetes Mellitus, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2% M.F. MilkOther
Also called 2% cow's milk, Neilsen Canada, White milk
White BreadOther
Also called White toast, Wonder Bread Canada
Strawberry JamOther
Also called Pure strawberry jam (not seedless), Fruit jam, Smucker's
31% M.F. Cheddar CheeseOther
Also called Mild cheddar cheese, Hard cheese, Armstrong Canada
2% M.F. Plain Greek yogurtOther
Also called Yogurt, Oikos, Danone Canada
Soy BeverageOther
Also called Soy milk, Non-dairy alternative, So Good, Vanilla
WaterOther
Also called Calorie-free control
| Study group | Role | What they receive |
|---|---|---|
| 2% M.F. Milk | Experimental | Breakfast meal: 250 mL 2% M.F. milk, 75 g white toast, 23.2 g strawberry jam, 100 mL water Receives: Other: 2% M.F. Milk; Other: White Bread; Other: Strawberry Jam |
| 2% M.F. Plain Greek Yogurt | Experimental | Breakfast meal: 175 g 2% plain Greek yogurt, 75 g white toast, 23.2 g strawberry jam, 100 mL + 75 mL water Receives: Other: White Bread; Other: Strawberry Jam; Other: 2% M.F. Plain Greek yogurt |
| 31% M.F. Cheddar Cheese | Experimental | Breakfast meal: 30 g 31% M.F. cheddar cheese, 75 g white toast, 27.0 g strawberry jam, 100 mL + 220 mL water Receives: Other: White Bread; Other: Strawberry Jam; Other: 31% M.F. Cheddar Cheese |
| Soy Beverage | Experimental | Breakfast meal: 250 mL soy beverage, 75 g white toast, 19.3 g strawberry jam, 100 mL water Receives: Other: White Bread; Other: Strawberry Jam; Other: Soy Beverage |
| Water (control) | Experimental | Breakfast meal: 250 mL + 100 mL water Receives: Other: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Glucose
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Measured: 0-210 minutes
Subjective Appetite
Subjective appetite ratings are obtained from four 100 mm visual analogue scale (VAS) questions assessing "Desire to Eat", "Hunger", "Fullness" and "Prospective Food Consumption". The average of all four VAS is calculated to obtain the average appetite score for statistical analysis.
Measured: 0-210 minutes
Secondary outcomes (2)
Insulin
Blood insulin (μU/mL) is measured using finger prick capillary blood samples
Measured: 0-210 minutes
Food Intake
Food at an ad libitum lunch meal consisting of a dish of rice, meatballs, and tomato sauce will be weighed to determine food intake based on nutrition information provided by the manufacturers.
Measured: 180-200 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Responsible party
- Principal investigator, G. Harvey Anderson, University of Toronto
- Investigators
- G. Harvey Anderson, Ph.D., Principal investigator, Department of Nutritional Sciences, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607007
- Sponsor's protocol ID
- DFC_31936
- Status last verified
- May 2016
- First submitted
- 13 Nov 2015
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dairy and Non-dairy Breakfasts on Subjective Appetite Ratings, Food Intake, and Post-meal Glycemia in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT02607007
- Acronym / sponsor ID
- DFC_31936
- Keywords
- Dairy, Post-prandial Glycemia, Satiety, Food Intake, Insulin, Milk, Greek yogurt, Cheese
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- Oct 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 17 Nov 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.
This study investigates the effects of dairy breakfasts (2% cow's milk, 2% Greek yogurt, cheese) and a non-dairy breakfast (soy beverage) on satiety and post-meal blood glucose. Each participant will receive every treatment in this crossover design study.
Detailed description
Regular consumption of dairy is associated with better body composition and lower incidences of type 2 diabetes and obesity. This may be due to dairy's ability to increase satiety and decrease post-prandial glycemia. However, most clinical studies have only investigated isolated dairy proteins (whey and casein) and the effects of whole dairy products, consumed as part of a meal, remain unclear. Additionally, the effect of dairy type and form remain to be further investigated. Therefore, this study will test the effects of dairy products when consumed with a high glycemic index breakfast on satiety and post-prandial glycemia.
Thirty healthy older males and females (60-70 years, BMI 18.5-30.0 kg/m2) will be recruited for the randomized, unblinded, crossover study. Participants will fast overnight, and at baseline will consume 1) 2% milk (250 mL), 2) soy beverage (250 mL), 3) plain 2% Greek yogurt (175 g), 4) cheddar cheese (30 g), or 5) water (250 mL - control). Treatments will be consumed along with 2 pieces of white toast with strawberry jam, except for the water control which will be consumed alone. All breakfast meals will be isocaloric and water will be given with the yogurt (75 mL) and cheese (220 mL) to compensate for fluid content. At 0 (baseline), 15, 30, 45, 60, 90, 120, 150, 180, (pre-meal period) and 210 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes. Between 180-200 minutes, an ad libitum lunch will be provided to assess food intake.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 2% M.F. Milk | Experimental | Other: 2% M.F. Milk, Other: White Bread, Other: Strawberry JamBreakfast meal: 250 mL 2% M.F. milk, 75 g white toast, 23.2 g strawberry jam, 100 mL water |
| 2% M.F. Plain Greek Yogurt | Experimental | Other: White Bread, Other: Strawberry Jam, Other: 2% M.F. Plain Greek yogurtBreakfast meal: 175 g 2% plain Greek yogurt, 75 g white toast, 23.2 g strawberry jam, 100 mL + 75 mL water |
| 31% M.F. Cheddar Cheese | Experimental | Other: White Bread, Other: Strawberry Jam, Other: 31% M.F. Cheddar CheeseBreakfast meal: 30 g 31% M.F. cheddar cheese, 75 g white toast, 27.0 g strawberry jam, 100 mL + 220 mL water |
| Soy Beverage | Experimental | Other: White Bread, Other: Strawberry Jam, Other: Soy BeverageBreakfast meal: 250 mL soy beverage, 75 g white toast, 19.3 g strawberry jam, 100 mL water |
| Water (control) | Experimental | Other: WaterBreakfast meal: 250 mL + 100 mL water |
Who may qualify
- Ages
- 60 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy BMI (18.5-30.0 kg/m2)
- Regular breakfast consumers
- Menopausal for at least 1 year (females)
Key exclusion criteria (8 listed)
- Smoking
- Diabetes
- Fasting blood glucose equal to or higher than 6.0 mmol/L
- Cardiovascular disease
- Medication affecting appetite or metabolism
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 |
|---|---|---|
| 2% M.F. MilkAlso: 2% cow's milk, Neilsen Canada, White milk | Other | 2% M.F. Milk |
| White BreadAlso: White toast, Wonder Bread Canada | Other | 2% M.F. Milk, 2% M.F. Plain Greek Yogurt, 31% M.F. Cheddar Cheese, Soy Beverage |
| Strawberry JamAlso: Pure strawberry jam (not seedless), Fruit jam, Smucker's | Other | 2% M.F. Milk, 2% M.F. Plain Greek Yogurt, 31% M.F. Cheddar Cheese, Soy Beverage |
| 31% M.F. Cheddar CheeseAlso: Mild cheddar cheese, Hard cheese, Armstrong Canada | Other | 31% M.F. Cheddar Cheese |
| 2% M.F. Plain Greek yogurtAlso: Yogurt, Oikos, Danone Canada | Other | 2% M.F. Plain Greek Yogurt |
| Soy BeverageAlso: Soy milk, Non-dairy alternative, So Good, Vanilla | Other | Soy Beverage |
| WaterAlso: Calorie-free control | Other | Water (control) |
Primary outcome
Blood Glucose
Time frame: 0-210 minutes
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Subjective Appetite
Time frame: 0-210 minutes
Subjective appetite ratings are obtained from four 100 mm visual analogue scale (VAS) questions assessing "Desire to Eat", "Hunger", "Fullness" and "Prospective Food Consumption". The average of all four VAS is calculated to obtain the average appetite score for statistical analysis.
2 secondary outcomes
Insulin
Time frame: 0-210 minutes
Food Intake
Time frame: 180-200 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 12 May 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.
G. Harvey Anderson, Ph.D. principal investigator
Department of Nutritional Sciences, 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 Phase 1/2 study testing 2% M.F. Milk, White Bread and Strawberry Jam in people with Diabetes and Obesity, 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 3 inclusion and 8 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 12 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 (time frame: 0-210 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 12 May 2016.