Clinical trial NCT03207607: Mid-morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake
Official title: The Effect of Mid-Morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Satiety
Food Intake
Keywords: Adults
Snacks
Appetite
Blood glucose
Insulin
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: The Hershey Company
First posted: 2017-07-05
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to determine the effect of mid-morning gel snacks on subjective appetite, glucose and insulin responses, and food intake in healthy weight young adults.

Detailed description: 23 (14 male, 9 female) healthy, non-smoking human subjects aged 18-30 years with a body mass index (BMI) between 20 and 24.9 were recruited in the experiment. Five gel snacks including a control snack and four modified snacks containing whey protein, oats, coconut oil or maltodextrin were tested. On six separate mornings, at least 3 days apart and after a 12 hours overnight fast, each participant consumed a standardized breakfast of cereal, milk, and orange juice at home, then arrived in the lab 2 hours after breakfast to receive one of the five test snack treatments or skip snack. Subjective appetite by a 100 mm visual analogue scale (VAS) was measured at baseline (0 min) and after each treatment up to 2 h (15, 30, 60, 90, and 120 min). Blood glucose and insulin concentrations were measured via finger-prick at the same time VAS measurements were taken. Food intake was measured via ad libitum pizza lunch.

Eligibility criteria: Inclusion Criteria:

* be between 18 and 30 years of age
* be healthy, non-smoking and not be taking any medications, including birth control
* body mass index (BMI) between 20 and 24.9

Exclusion Criteria:

* fasting plasma glucose \>5.5 mmol/L
* health problems including previously diagnosed diabetes, known or uncertain pregnancy status at screening, gastrointestinal disease, liver or kidney disease
* major medical or surgical event within the past 6 months
* current or recent dieting
* breakfast skipping
* receiving any medications
* menstrual irregularities
* food sensitivities, allergies, intolerances, or dietary restrictions to foods including: cereal, orange juice, dairy, oat, coconut oil, honey, apple, pineapple, strawberry, and pear
* behavioural or emotional problems
* alcohol consumption \>7 beverages/week

Primary outcomes:
measure: Subjective Appetite
timeFrame: Change from baseline over 120 minutes
Secondary outcomes:
measure: Blood Glucose Response
timeFrame: Change from baseline over 120 minutes
measure: Blood Insulin Response
timeFrame: Change from baseline over 120 minutes
measure: Food Intake
timeFrame: 30 min
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: School of Nutrition, Ryerson University
state: Ontario
Study officials:
affiliation: Toronto Metropolitan University
name: Nick Bellissimo, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Toronto Metropolitan University
name: Derick Rousseau, PhD
role: PRINCIPAL_INVESTIGATOR
References: