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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03207607
Other study ID # REB2015-405
Secondary ID
Status Completed
Phase N/A
First received June 29, 2017
Last updated July 3, 2017
Start date February 2016
Est. completion date August 2016

Study information

Verified date June 2017
Source Ryerson University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date August 2016
Est. primary completion date August 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Control snack
Isovolumetric (238.4g) gel snack prepared by real fruits (186.2kcal)
Maltodextrin snack
Isovolumetric (238.4g) gel snack with maltodextrin (271.8kcal)
Whey protein snack
Isovolumetric (238.4g) gel snack with whey protein (201.8kcal)
Oat snack
Isovolumetric (238.4g) gel snack with oats and maltodextrin (275.8kcal)
Coconut oil snack
Isovolumetric (238.4g) gel snack with coconut oil (276.4kcal)
Snack skipping
no snack

Locations

Country Name City State
Canada School of Nutrition, Ryerson University Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Ryerson University The Hershey Company

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Subjective Appetite Participants completed subjective ratings on appetite (e.g., desire to eat, hunger, fullness, prospective food consumption) and well-being at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch. Change from baseline over 120 minutes
Secondary Blood Glucose Response Blood was collected at baseline (0min), 15, 30, 45, 60, 90, and 120 min after snack consumption, as well as immediately following lunch to observe glycemic responses to gel snacks Change from baseline over 120 minutes
Secondary Blood Insulin Response Blood was collected at baseline (0 min), 15, 30, 45, 60, 90, and 120 min after meal consumption, as well as immediately following lunch, to observe insulin responses to gel snacks Change from baseline over 120 minutes
Secondary Food Intake Participants consumed an ad libitum pizza lunch at 120 minutes 30 min
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