Effects of Viscous Fibre Containing Foods on Satiety (Gel Form)
Effects of High-Fibre, Low-Energy Density Viscous Gel Meals on Satiety, Appetite Regulation and Subsequent Food Intake in Healthy Individuals
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 14, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2014
CompletedMay 9, 2014
April 1, 2014
1.2 years
April 14, 2014
May 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Subjective Satiety
Subjects will record their subjective satiety ratings using a 100 mm visual analogue scale and these ratings will be combined into a total subjective appetite score using the formula (Q1+Q2+(100-Q3)+Q4)/4.
12 hours for each of the 3 study visits.
Secondary Outcomes (6)
Ambulatory Blood Pressure
Measured at the beginning of each of the 3 study visits and every 30 minutes thereafter until 10:00pm the same day.
Height and Weight
Taken once at the beginning of each of the 3 clinical visits.
Blood Samples
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).
Palatability Scores
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.
Food Craving Rating
Rated immediately prior (0min) to eating each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
- +1 more secondary outcomes
Study Arms (3)
Konjac Glucomannan
EXPERIMENTAL650g KJM-G
Half Control/Half Konjac Glucomannan
EXPERIMENTAL325g KJM-G
Control
NO INTERVENTION0g KJM-G
Interventions
Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Risk Factor and Modification Centre
Toronto, Ontario, M5C 2T2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vladimir Vuksan, PhD
Risk Factor Modification Centre - St. Michael's Hospital
- PRINCIPAL INVESTIGATOR
Alexandra Jenkins (Co-Investigator), RD, PhD
Risk Factor Modification Centre - St. Michael's Hospital
- PRINCIPAL INVESTIGATOR
William Watson (Qualified Investigator), MD
Department of Family Medicine - St. Michael's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2014
First Posted
May 9, 2014
Study Start
July 1, 2013
Primary Completion
September 1, 2014
Last Updated
May 9, 2014
Record last verified: 2014-04