DiabetesPhase 1/2NCT02491814
The Effect of Dairy and Non-dairy Alternatives on Satiety and Post-meal Glycemia in Healthy Young Adults
A Phase 1/2 study testing 1% M.F. Milk, Yogurt Beverage and Soy Beverage in people with Diabetes and Obesity, run by University of Toronto at 1 site in Canada.
Trial summary
This study investigates the effects of commercially-available dairy (1% cow's milk and yogurt beverage) and non-dairy alternatives (almond and soy beverages) 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 20 to 30 yearsHealthy volunteers can take part
- What is being tested?
- 1% M.F. Milk, Yogurt Beverage and Soy Beverage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2015to Jun 2015
- 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 20 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy BMI (20.0 - 24.9 kg/m2)
- Females with regular monthly menstrual cycles
Who cannot join
- Diabetes
- Fasting blood glucose higher than 5.8 mmol/L
- Pregnancy
- Medications
- Smoking
- Lactose intolerance or allergies to milk, soy, or almonds
Show all 10Show fewer
- Elite athletes
- Those trying to lose or gain weight
- Breakfast skippers and those on an energy-restricted diet
- 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, FitzGerald Building
Toronto, Ontario, M5S 3E2
About this study
Official title: The Effect of Commercially-available Dairy and Non-dairy Alternatives When Consumed With a High Glycemic Cereal on Subjective Appetite Ratings and Post-meal Glycemia in Healthy Young Adults
This study investigates the effects of commercially-available dairy (1% cow's milk and yogurt beverage) and non-dairy alternatives (almond and soy beverages) 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 remains unclear. Additionally, as non-dairy alternatives are becoming more popular there is interest to see if they can elicit similar benefits as dairy. Therefore, this study will test the effects of commercially-available dairy and non-dairy beverages when consumed with cereal at breakfast time.
Thirty healthy young males and females (20-30 years, BMI 20.0-24.9 kg/m2) will be recruited for the randomized, unblinded, crossover study. Participants will fast overnight, and at baseline will consume 250 mL of 1% milk, soy beverage, almond beverage, yogurt beverage, or water with 54 g of Cheerios cereal. At 0 (baseline), 15, 30, 45, 60, 75, 90, 120 minutes (pre-meal period) 140, and 170 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes and for the last two timepoints. Between 120-140 minutes, an ad libitum lunch will be provided to assess food intake.
- Being tested
- 1% M.F. Milk, Yogurt Beverage, Soy Beverage, Almond Beverage, Water
- Keywords
- Dairy, Breakfast cereal, Postprandial Glycemia, Satiety, Food Intake, Milk, Yogurt, Soy, Almond
- Medical subject headings
- Diabetes Mellitus, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1% M.F. MilkOther
Also called 1% cow's milk, Neilsen Canada
Yogurt BeverageOther
Also called Yop (Vanilla), General Mills
Soy BeverageOther
Also called Soy Milk, Silk Organic Original
Almond BeverageOther
Also called Almond Milk, Silk Original
WaterOther
Also called Calorie-free control
Breakfast cerealOther
Also called Cheerios, General Mills
| Study group | Role | What they receive |
|---|---|---|
| 1% M.F. Milk and Breakfast Cereal | Experimental | Breakfast meal: 250 ml 1% M.F. Milk, 54 g Cheerios breakfast cereal, 100 mL water Receives: Other: 1% M.F. Milk; Other: Breakfast cereal |
| Yogurt Beverage and Breakfast Cereal | Experimental | Breakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water Receives: Other: Yogurt Beverage; Other: Breakfast cereal |
| Soy Beverage and Breakfast Cereal | Experimental | Breakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water Receives: Other: Soy Beverage; Other: Breakfast cereal |
| Almond Beverage and Breakfast Cereal | Experimental | Breakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water Receives: Other: Almond Beverage; Other: Breakfast cereal |
| Water (control) and Breakfast Cereal | Experimental | Breakfast meal: 250 ml Water, 54 g Cheerios breakfast cereal, 100 mL water Receives: Other: Water; Other: Breakfast cereal |
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: 0-170 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: 0-170 minutes
Secondary outcomes (2)
Insulin
Blood insulin (μU/mL) is measured using finger prick capillary blood samples
Measured: 0-170 minutes
Food Intake
Food at an ad libitum pizza lunch will be weighed to determine food intake based on nutrition information provided by the pizza manufacturer
Measured: 120-140 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionJun 2015
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
- 28 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
- NCT02491814
- Sponsor's protocol ID
- DFC_31012
- Status last verified
- May 2016
- First submitted
- 27 May 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 Commercially-available Dairy and Non-dairy Alternatives When Consumed With a High Glycemic Cereal on Subjective Appetite Ratings and Post-meal Glycemia in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT02491814
- Acronym / sponsor ID
- DFC_31012
- Keywords
- Dairy, Breakfast cereal, Postprandial Glycemia, Satiety, Food Intake, Milk, Yogurt, Soy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Dairy Farmers of Canada
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 8 Jul 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 commercially-available dairy (1% cow's milk and yogurt beverage) and non-dairy alternatives (almond and soy beverages) 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 remains unclear. Additionally, as non-dairy alternatives are becoming more popular there is interest to see if they can elicit similar benefits as dairy. Therefore, this study will test the effects of commercially-available dairy and non-dairy beverages when consumed with cereal at breakfast time.
Thirty healthy young males and females (20-30 years, BMI 20.0-24.9 kg/m2) will be recruited for the randomized, unblinded, crossover study. Participants will fast overnight, and at baseline will consume 250 mL of 1% milk, soy beverage, almond beverage, yogurt beverage, or water with 54 g of Cheerios cereal. At 0 (baseline), 15, 30, 45, 60, 75, 90, 120 minutes (pre-meal period) 140, and 170 minutes (post-meal period) blood will be collected for glucose analysis and subjective appetite ratings completed. Insulin will be analyzed every 30 minutes and for the last two timepoints. Between 120-140 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 |
|---|---|---|
| 1% M.F. Milk and Breakfast Cereal | Experimental | Other: 1% M.F. Milk, Other: Breakfast cerealBreakfast meal: 250 ml 1% M.F. Milk, 54 g Cheerios breakfast cereal, 100 mL water |
| Yogurt Beverage and Breakfast Cereal | Experimental | Other: Yogurt Beverage, Other: Breakfast cerealBreakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water |
| Soy Beverage and Breakfast Cereal | Experimental | Other: Soy Beverage, Other: Breakfast cerealBreakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water |
| Almond Beverage and Breakfast Cereal | Experimental | Other: Almond Beverage, Other: Breakfast cerealBreakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water |
| Water (control) and Breakfast Cereal | Experimental | Other: Water, Other: Breakfast cerealBreakfast meal: 250 ml Water, 54 g Cheerios breakfast cereal, 100 mL water |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy BMI (20.0 - 24.9 kg/m2)
- Females with regular monthly menstrual cycles
Key exclusion criteria (10 listed)
- Diabetes
- Fasting blood glucose higher than 5.8 mmol/L
- Pregnancy
- Medications
- Smoking
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 |
|---|---|---|
| 1% M.F. MilkAlso: 1% cow's milk, Neilsen Canada | Other | 1% M.F. Milk and Breakfast Cereal |
| Yogurt BeverageAlso: Yop (Vanilla), General Mills | Other | Yogurt Beverage and Breakfast Cereal |
| Soy BeverageAlso: Soy Milk, Silk Organic Original | Other | Soy Beverage and Breakfast Cereal |
| Almond BeverageAlso: Almond Milk, Silk Original | Other | Almond Beverage and Breakfast Cereal |
| WaterAlso: Calorie-free control | Other | Water (control) and Breakfast Cereal |
| Breakfast cerealAlso: Cheerios, General Mills | Other | 1% M.F. Milk and Breakfast Cereal, Almond Beverage and Breakfast Cereal, Soy Beverage and Breakfast Cereal, Water (control) and Breakfast Cereal, Yogurt Beverage and Breakfast Cereal |
Primary outcome
Blood Glucose
Time frame: 0-170 minutes
Blood glucose (mmol/L) is measured using finger prick capillary blood samples
Subjective Appetite
Time frame: 0-170 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: 0-170 minutes
Food Intake
Time frame: 120-140 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 1% M.F. Milk, Yogurt Beverage and Soy Beverage 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 2 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 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: 0-170 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.