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

Study Overview
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Brief Summary
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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.

Official Title
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Effects of High-Fibre, Low-Energy Density Viscous Gel Meals on Satiety, Appetite Regulation and Subsequent Food Intake in Healthy Individuals

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: Konjac Glucomannan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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. |