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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04183855
Other study ID # 115099
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date August 31, 2020

Study information

Verified date November 2019
Source Western University, Canada
Contact Crystal Lee, BSc
Phone 519 6612111
Email plee263@uwo.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Participants will be given a drink (and no drink for one of the treatments) prior to a pizza dinner. Ratings on satiety, appetite and desire to eat will be asked with the use of a questionnaire. Blood glucose will also be measured. One hour after the drink, participants will be given a pizza and can eat as much as they want. The pizza remaining will be weighed.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date August 31, 2020
Est. primary completion date June 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 40 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Generation UCAN supplementation
carbohydrates - protein (Generation UCAN supplement, 250ml, 10% solution)
Mirexus PhytoSpherix supplementation
carbohydrates alone (Mirexus PhytoSpherix, 250ml, 10% solution)
Behavioral:
satiety ratings
questionnaire on satiety ratings will be provided to participants 15, 30, 45 and 60 min after the drink (or no drink)

Locations

Country Name City State
Canada Exercise Nutrition Laboratory (Western University) London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary changes in satiety ratings 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
Primary Food intake food intake after each treatment will be measured by weighing the left over pizza slices 90 min after the drink
Secondary changes in appetite ratings 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
Secondary changes in blood glucose after the drink blood glucose will be measured through finger pricks 15, 30, 45, 60 min after the drink
Secondary changes in desire to eat ratings 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
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