- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03207607
Mid-morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake
July 3, 2017 updated by: Nick Bellissimo, Ryerson University
The Effect of Mid-Morning Gel Snacks on Subjective Appetite, Glycemic and Insulin Responses, and Food Intake in Healthy Adults
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.
Study Overview
Status
Completed
Conditions
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.
Study Type
Interventional
Enrollment (Actual)
23
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
-
-
Ontario
-
Toronto, Ontario, Canada, M5B 2K3
- School of Nutrition, Ryerson 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
18 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 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: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control snack
Participants received control snacks prepared by real fruits (pear, orange and mango)
|
Isovolumetric (238.4g)
gel snack prepared by real fruits (186.2kcal)
|
Experimental: Maltodextrin snack
Participants received maltodextrin snacks (maltodextrin + control snack)
|
Isovolumetric (238.4g)
gel snack with maltodextrin (271.8kcal)
|
Experimental: Whey protein snack
Participants received whey protein snacks (whey protein + control snack)
|
Isovolumetric (238.4g)
gel snack with whey protein (201.8kcal)
|
Experimental: Oat snack
Participants received oat snacks (oat + maltodextrin + control snack)
|
Isovolumetric (238.4g)
gel snack with oats and maltodextrin (275.8kcal)
|
Experimental: Coconut oil snack
Participants received coconut oil snacks (coconut oil + control snack)
|
Isovolumetric (238.4g)
gel snack with coconut oil (276.4kcal)
|
Experimental: Snack skipping
Participants received snack skipping
|
no snack
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Appetite
Time Frame: Change from baseline over 120 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Blood Glucose Response
Time Frame: Change from baseline over 120 minutes
|
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
|
Blood Insulin Response
Time Frame: Change from baseline over 120 minutes
|
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
|
Food Intake
Time Frame: 30 min
|
Participants consumed an ad libitum pizza lunch at 120 minutes
|
30 min
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Derick Rousseau, PhD, Ryerson 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)
February 1, 2016
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
June 29, 2017
First Submitted That Met QC Criteria
July 3, 2017
First Posted (Actual)
July 5, 2017
Study Record Updates
Last Update Posted (Actual)
July 5, 2017
Last Update Submitted That Met QC Criteria
July 3, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- REB2015-405
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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