Effects of Viscous Fibre Containing Foods on Satiety (Gel Form)

Phase 1

• Conditions: Obesity
• Interventions: Dietary Supplement: Konjac Glucomannan

• Registration Number: NCT02134938
• Lead Sponsor: Unity Health Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Status Verified: 2014-04
• Study First Submitted: 2014-04-14
• Study First Submitted QC: 2014-05-07
• Last Update Submitted: 2014-05-07
• Study First Posted: 2014-05-09
• Last Update Posted: 2014-05-09
• Primary Completion: 2014-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Konjac Glucomannan	Konjac Glucomannan	650g KJM-G
Half Control/Half Konjac Glucomannan	Konjac Glucomannan	325g KJM-G

Primary Outcome Measures

Name	Time	Method
Subjective Satiety	12 hours for each of the 3 study visits.	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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
Subsequent 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.	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.
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).	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.
Food Craving Rating	Rated immediately prior (0min) to eating each meal (Breakfast, Lunch, Snack and Dinner) for each of the 3 study visits.	Subjects will record their subjective food craving ratings, if any, prior to each meal, using a 100mm visual analogue scale.

Trial Locations

Locations (1)

Clinical Risk Factor and Modification Centre; 🇨🇦 Toronto, Ontario, Canada