NCT03914430

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2016

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 2, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

8 months

First QC Date

April 2, 2019

Last Update Submit

April 11, 2019

Conditions

Blood GlucoseEatingFood

Keywords

BreakfastBlood glucoseFood intakeSatiety

Outcome Measures

Primary Outcomes (3)

  • Postprandial blood glucose concentration

    The concentration of blood glucose in venous blood after the ad libitum breakfast meal or water control.

    0-120 minutes

  • Subjective feeling of appetite

    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

    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 Outcomes (3)

  • Circulatory insulin concentration

    0-120 minutes

  • Subjective feeling of physical comfort

    0-120 minutes

  • Subjective feeling of food palatability (pleasantness)

    0, 120 minutes

Study Arms (3)

Breakfast meal with granola cereal and cultured dairy

EXPERIMENTAL
Other: Food

Breakfast meal with granola cereal and cultured non-dairy

EXPERIMENTAL
Other: Food

Water

EXPERIMENTAL

Energy-free control

Other: Food

Interventions

FoodOTHER

The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)

Breakfast meal with granola cereal and cultured dairyBreakfast meal with granola cereal and cultured non-dairyWater

Eligibility Criteria

Age19 Years - 28 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy females

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Saint Vincent University

Halifax, Nova Scotia, B3M 2J6, Canada

Location

MeSH Terms

Interventions

Food

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Bohdan Luhovyy, PhD

    Mount Saint Vincent University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 2, 2019

First Posted

April 16, 2019

Study Start

November 20, 2015

Primary Completion

July 30, 2016

Study Completion

November 17, 2017

Last Updated

April 16, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)