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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02134938
• Other study ID #: KJM-G
• Status: Recruiting
• Phase: Phase 1
• First received: April 14, 2014
• Last updated: May 7, 2014
• Start date: July 2013

Study information

• Verified date: April 2014
• Source: St. Michael's Hospital, Toronto
• Contact: Rodney Au-Yeung, BSc
• Phone: (416) 864-6060
• Email: auyeungf[@]smh.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Konjac Glucomannan
Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes

Locations

Country	Name	City	State
Canada	Clinical Risk Factor and Modification Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No
Secondary	Height and Weight		Taken once at the beginning of each of the 3 clinical visits.	No
Secondary	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).	No
Secondary	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.	No
Secondary	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.	No
Secondary	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.	No