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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Konjac Glucomannan

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rodney Au-Yeung, BSc; Phone Number: 5526 (416) 864-6060; Email: auyeungf@smh.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5C 2T2
      • Recruiting
      • Clinical Risk Factor and Modification Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Konjac Glucomannan; 650g KJM-G	Dietary supplement: Konjac Glucomannan; Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes
Experimental: Half Control/Half Konjac Glucomannan; 325g KJM-G	Dietary supplement: Konjac Glucomannan; Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes
No Intervention: Control; 0g KJM-G

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Capillary blood samples will be collected in anticoagulant containing tubes stored at -20°C and analyzed by trained personnel for plasma glucose concentration using the glucose oxidase method by YSI 2300 STAT Plus within 48 hours.	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	Subjects will record their subjective food craving ratings, if any, prior to each meal, using a 100mm visual analogue scale.	Rated immediately prior (0min) to eating each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.
Subsequent Food Intake	Subjects will record their subsequent food intake from 12h to 24h post first meal. Food record will be analyzed with The Nutrition Food Processor (ESHA) and data will be tabulated and included as part of the cumulative daily food intake.	Recorded from the 12th to the 24th hour after beginning the first meal (Breakfast at 0min) for each of the 3 study visits.

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): September 1, 2014

Study Registration Dates

• First Submitted: April 14, 2014
• First Submitted That Met QC Criteria: May 7, 2014
• First Posted (Estimate): May 9, 2014

Study Record Updates

• Last Update Posted (Estimate): May 9, 2014
• Last Update Submitted That Met QC Criteria: May 7, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gastrointestinal Agents; Cathartics; (1-6)-alpha-glucomannan
• Other Study ID Numbers: KJM-G