Clinical trial NCT02134938: Effects of Viscous Fibre Containing Foods on Satiety (Gel Form)
Official title: Effects of High-Fibre, Low-Energy Density Viscous Gel Meals on Satiety, Appetite Regulation and Subsequent Food Intake in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Obesity
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2014-05-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess whether low caloric, low energy density, konjac food products are effective in appetite regulation when administered as caloric replacements. It is hypothesized that replacement of typical, balanced, vegetarian meals with konjac food products will have comparable satiety scores, decreased postprandial glucose response, and will not significantly affect subsequent food intake.


Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking males and females
* Aged 18-70 years
* BMI between 18 - 29.9 kg/m²
* Non-dieters (1-10 score on Stunkard Eating Inventory)

Exclusion Criteria:

* Known reported history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, Celiac disease/gastrointestinal disease, or AIDS
* Weight change of +/- 3kg in the last 2 months
* Alcohol intake \>2 drinks/day
* Inability to consume KJM-G meals
* Any condition which might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results
* Non-compliance with experimental procedures or safety guidelines

Primary outcomes:
measure: Subjective Satiety
timeFrame: 12 hours for each of the 3 study visits.
Secondary outcomes:
measure: Ambulatory Blood Pressure
timeFrame: Measured at the beginning of each of the 3 study visits and every 30 minutes thereafter until 10:00pm the same day.
measure: Height and Weight
timeFrame: Taken once at the beginning of each of the 3 clinical visits.
measure: Blood Samples
timeFrame: One sample taken immediately prior to (0min) eating each meal (Breakfast, Lunch, Snack and Dinner) and at 30, 60, 90 and 120 min after eating the Breakfast and Lunch meals for each of the 3 study visits (total of 12 blood samples per study visit).
measure: Palatability Scores
timeFrame: Measured immediately after eating and finishing (<15min after the first bite) each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
measure: Food Craving Rating
timeFrame: Rated immediately prior (0min) to eating each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
measure: Subsequent Food Intake
timeFrame: Recorded from the 12th to the 24th hour after beginning the first meal (Breakfast at 0min) for each of the 3 study visits.
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Clinical Risk Factor and Modification Centre
state: Ontario
Study officials:
affiliation: Risk Factor Modification Centre - St. Michael's Hospital
name: Vladimir Vuksan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Risk Factor Modification Centre - St. Michael's Hospital
name: Alexandra Jenkins (Co-Investigator), RD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Family Medicine - St. Michael's Hospital
name: William Watson (Qualified Investigator), MD
role: PRINCIPAL_INVESTIGATOR
References: