- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03914430
Breakfast Cereals Consumed in Dairy and Non-dairy Medium: the Effects on Blood Glucose, Satiety and Food Intake
April 11, 2019 updated by: Bohdan Luhovyy, Mount Saint Vincent University
The Effect of Dairy and Non-Dairy Cultured Products Added to Breakfast Cereals on Satiation, Satiety, Blood Glucose Control and Short-Term Food Intake in Young Adults
The effects of dairy-free products consumed with a breakfast meal on food intake and glycaemic regulation remain unexplored.
It is known that dairy products are an excellent source of protein, low glycaemic sugar lactose, calcium, and vitamin D. In our recent study the consumption of a dairy snack with high protein content resulted in reduced blood glucose response compared to non-dairy snack with the similar amount of available carbohydrate.
The investigators hypothesize that the ad libitum intake of breakfast cereals served with a high-protein fermented dairy product will result in reduced and sustained blood glucose response compared to non-dairy control.
The objective of this study is to investigate how dairy and non-dairy cultured products used as carriers for breakfast granola cereals and consumed ad libitum affect short-term food intake, satiety, and glycaemia within two hours.
Study Overview
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3M 2J6
- Mount Saint Vincent University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 28 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Healthy females
Exclusion Criteria:
- Overweight or obese
- Breakfast skippers
- Have any chronic metabolic diseases
- Smokers
- Taking medications
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Breakfast meal with granola cereal and cultured dairy
|
The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)
|
Experimental: Breakfast meal with granola cereal and cultured non-dairy
|
The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)
|
Experimental: Water
Energy-free control
|
The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial blood glucose concentration
Time Frame: 0-120 minutes
|
The concentration of blood glucose in venous blood after the ad libitum breakfast meal or water control.
|
0-120 minutes
|
Subjective feeling of appetite
Time Frame: 0-120 minutes
|
The subjective assessment of appetite parameters including desire to eat, fullness, hunger and a prospectiove food consumption measured with 100 mm Visual Analogue Scales with two opposite statements at each end (e.g., for the hunger scale, 0 mm means not hungry at all, and 100 mm means very hungry).
|
0-120 minutes
|
Ad libitum food intake
Time Frame: 0-120 minutes
|
The amount of energy (kcal) consumed ad libitum with the breakfast meal or water control and with the test meal (pizza lunch) two hour later.
|
0-120 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Circulatory insulin concentration
Time Frame: 0-120 minutes
|
The concentration of insulin in blood
|
0-120 minutes
|
Subjective feeling of physical comfort
Time Frame: 0-120 minutes
|
The subjective assessment of wellness and gastrointestinal symptoms including feeling of nausea, diarrhoea, flatulence and other parameters measured with 100 mm Visual Analogue Scales with two opposite statements at each end.
|
0-120 minutes
|
Subjective feeling of food palatability (pleasantness)
Time Frame: 0, 120 minutes
|
The pleasantness of the breakfast meal and pizza meal measured with 100 mm Visual Analogue Scales with two opposite statements at each end.(e.g., 0 mm means that food is not pleasant at all, and 100 mm means that the food is very pleasant).
|
0, 120 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bohdan Luhovyy, PhD, Mount Saint Vincent University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2015
Primary Completion (Actual)
July 30, 2016
Study Completion (Actual)
November 17, 2017
Study Registration Dates
First Submitted
April 2, 2019
First Submitted That Met QC Criteria
April 11, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 16, 2019
Last Update Submitted That Met QC Criteria
April 11, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2015-013
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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