- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04183855
The Relationship Between Blood Glucose and Satiety Ratings
Study Overview
Status
Detailed Description
Each participant will receive all three treatments on separate occasions in random order (separated by a week). The three treatments include control (no supplement), carbohydrates - protein (Generation UCAN supplement, 250ml, 10% solution) and carbohydrates alone (Mirexus PhytoSpherix, 250ml, 10% solution). Participants will report to the lab between 4-5 pm and 4 hours after their last meal on day they have not exercised. Participants will record food intake the day of the first experiment and will be asked to replicate both type and quantity for subsequent visits. Upon arrival at the lab, baseline measures (blood glucose as well as rating of satiety ratings, appetite and desire to eat (10-point visual analogue scale). Then the treatment will be given and all the aforementioned variables will be remeasured at 15, 30, 45 and 60 minutes post drink. At 65 minutes, participants will be provided with an ad libitum pizza meal. Participants will be told to eat until they are "comfortably full" (Bellissimo et al., 2008). The pizza provided will be weighed initially and once the participant is done eating and has left the lab, the remaining pizza will be weighed and recorded. The pizza will be a cheese only pizza to minimize any difference in energy intake due to the location of additional items placed on the pizza.
Participants will not be told the true purpose of this experiment, instead they will be told that the pizza meal is a reward for participating in the study. Later, at the conclusion of the study all will be debriefed.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Exercise Nutrition Laboratory (Western University)
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Healthy males and females at the age of 18-40
- sedentary individuals
Exclusion Criteria:
- exercise more than twice per week
- does not like pizza
- do not eat three meals a day
- medications that affect eating patterns
- have metabolic and gastrointestinal diseases
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: control
no supplement will be provided on the day of the experiment
|
questionnaire on satiety ratings will be provided to participants 15, 30, 45 and 60 min after the drink (or no drink)
|
|
Experimental: Generation UCAN
carbohydrates - protein (Generation UCAN supplement, 250ml, 10% solution)
|
questionnaire on satiety ratings will be provided to participants 15, 30, 45 and 60 min after the drink (or no drink)
carbohydrates - protein (Generation UCAN supplement, 250ml, 10% solution)
|
|
Experimental: Mirexus PhytoSpherix
carbohydrates alone (Mirexus PhytoSpherix, 250ml, 10% solution)
|
questionnaire on satiety ratings will be provided to participants 15, 30, 45 and 60 min after the drink (or no drink)
carbohydrates alone (Mirexus PhytoSpherix, 250ml, 10% solution)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in satiety ratings after the drink
Time Frame: 15, 30, 45, 60 min after the drink
|
satiety ratings will be asked with the use a 10 point visual analog scale (VAS) questionnaire, 10 being do not want to consume any more food and 1 being strong desire to consume food
|
15, 30, 45, 60 min after the drink
|
|
Food intake
Time Frame: 90 min after the drink
|
food intake after each treatment will be measured by weighing the left over pizza slices
|
90 min after the drink
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
changes in appetite ratings after the drink
Time Frame: 15, 30, 45, 60 min after the drink
|
appetite ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being strong desire to consume food and 1 being no desire to consume food at all
|
15, 30, 45, 60 min after the drink
|
|
changes in blood glucose after the drink
Time Frame: 15, 30, 45, 60 min after the drink
|
blood glucose will be measured through finger pricks
|
15, 30, 45, 60 min after the drink
|
|
changes in desire to eat ratings
Time Frame: 15, 30, 45, 60 min after the drink
|
desire to eat ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being no desire to eat at all and 1 being strong desire to eat
|
15, 30, 45, 60 min after the drink
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 115099
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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