Obesity
Conditions
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.
Interventions
DIETARY_SUPPLEMENTKonjac Glucomannan
Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes
Sponsors
Unity Health Toronto
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. | — |
| 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. |
| 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. |
| 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. | — |
Countries
Canada
Contacts
Primary ContactRodney Au-Yeung, BSc
Outcome results
None listed