NCT04183855

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 18, 2020

Status Verified

November 1, 2019

Enrollment Period

5 months

First QC Date

November 26, 2019

Last Update Submit

January 13, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • Food intake

    food intake after each treatment will be measured by weighing the left over pizza slices

    90 min after the drink

Secondary Outcomes (3)

  • changes in appetite ratings after the drink

    15, 30, 45, 60 min after the drink

  • changes in blood glucose after the drink

    15, 30, 45, 60 min after the drink

  • changes in desire to eat ratings

    15, 30, 45, 60 min after the drink

Study Arms (3)

control

EXPERIMENTAL

no supplement will be provided on the day of the experiment

Behavioral: satiety ratings

Generation UCAN

EXPERIMENTAL

carbohydrates - protein (Generation UCAN supplement, 250ml, 10% solution)

Dietary Supplement: Generation UCAN supplementationBehavioral: satiety ratings

Mirexus PhytoSpherix

EXPERIMENTAL

carbohydrates alone (Mirexus PhytoSpherix, 250ml, 10% solution)

Dietary Supplement: Mirexus PhytoSpherix supplementationBehavioral: satiety ratings

Interventions

carbohydrates - protein (Generation UCAN supplement, 250ml, 10% solution)

Generation UCAN

carbohydrates alone (Mirexus PhytoSpherix, 250ml, 10% solution)

Mirexus PhytoSpherix
satiety ratingsBEHAVIORAL

questionnaire on satiety ratings will be provided to participants 15, 30, 45 and 60 min after the drink (or no drink)

Generation UCANMirexus PhytoSpherixcontrol

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and females at the age of 18-40
  • sedentary individuals

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

Location

Study Officials

  • Peter Lemon, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Lee, BSc

CONTACT

Manuel Quinones, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 26, 2019

First Posted

December 3, 2019

Study Start

February 1, 2020

Primary Completion

June 30, 2020

Study Completion

August 31, 2020

Last Updated

January 18, 2020

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations