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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Conditions the study is for
Diabetes, Obesity
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

Other trials in Canada

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.

Conditions
Diabetes, Obesity
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 groups in NCT02491814
Study groupRoleWhat they receive
1% M.F. Milk and Breakfast CerealExperimentalBreakfast 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 CerealExperimentalBreakfast meal: 250 ml Yogurt Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Receives: Other: Yogurt Beverage; Other: Breakfast cereal
Soy Beverage and Breakfast CerealExperimentalBreakfast meal: 250 ml Soy Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Receives: Other: Soy Beverage; Other: Breakfast cereal
Almond Beverage and Breakfast CerealExperimentalBreakfast meal: 250 ml Almond Beverage, 54 g Cheerios breakfast cereal, 100 mL water
Receives: Other: Almond Beverage; Other: Breakfast cereal
Water (control) and Breakfast CerealExperimentalBreakfast 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.

  1. Blood Glucose

    Blood glucose (mmol/L) is measured using finger prick capillary blood samples

    Measured: 0-170 minutes

  2. 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)

  1. Insulin

    Blood insulin (μU/mL) is measured using finger prick capillary blood samples

    Measured: 0-170 minutes

  2. 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.

  1. First posted8 Jul 2015 (estimated)
  2. Study startJan 2015
  3. Primary completionJun 2015
  4. Study completionJun 2015

Resources

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)
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

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?

On the ClinicalTrials.gov record for NCT02491814.

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; AzTrials last refreshed its copy on 8 Nov 2026.

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