Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Breakfast Cereals Consumed in Dairy and Non-dairy Medium: the Effects on Blood Glucose, Satiety and Food Intake

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03914430
Recruitment Status : Completed
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
University of Toronto
Dairy Farmers of Canada
Information provided by (Responsible Party):
Bohdan Luhovyy, Mount Saint Vincent University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Glucose Eating Food Other: Food Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: The participants were blinded and could not distinguish the breakfast cereals made with Greek yogurt or with cultured coconut product. The taste and flavour in both treatments was similar due to added blueberry flavouring.
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : November 20, 2015
Actual Primary Completion Date : July 30, 2016
Actual Study Completion Date : November 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arm Intervention/treatment
Experimental: Breakfast meal with granola cereal and cultured dairy Other: Food
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 Other: Food
The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)

Experimental: Water
Energy-free control
Other: Food
The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Secondary Outcome Measures :
  1. Circulatory insulin concentration [ Time Frame: 0-120 minutes ]
    The concentration of insulin in blood

  2. 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.

  3. 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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 28 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy females

Exclusion Criteria:

  • Overweight or obese
  • Breakfast skippers
  • Have any chronic metabolic diseases
  • Smokers
  • Taking medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03914430


Locations
Layout table for location information
Canada, Nova Scotia
Mount Saint Vincent University
Halifax, Nova Scotia, Canada, B3M 2J6
Sponsors and Collaborators
Mount Saint Vincent University
University of Toronto
Dairy Farmers of Canada
Investigators
Layout table for investigator information
Principal Investigator: Bohdan Luhovyy, PhD Mount Saint Vincent University
Layout table for additonal information
Responsible Party: Bohdan Luhovyy, Associate Professor, Mount Saint Vincent University
ClinicalTrials.gov Identifier: NCT03914430    
Other Study ID Numbers: 2015-013
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bohdan Luhovyy, Mount Saint Vincent University:
Breakfast
Blood glucose
Food intake
Satiety