Satiety Study of a Carbohydrate Meal to a Highly Viscous Gel Meal (InGel)

Comparing the Satiety Scores of a Carbohydrate Meal to a Meal of Equal Volume in Which Half of the Volume is Replaced With a Highly Viscous Gel.

To evaluate the effects of Konjac on satiety and subsequent food intake in healthy individuals.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: Konjac noodles; Dietary supplement: Carbohydrate and Konjac Noodles; Dietary supplement: Carbohydrate noodles

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1W8
      • Risk Factor Modification Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men and women
• Age 18-65 years
• Having a BMI of 18.5 - 25 kg/m2
• No presence of major disease

Exclusion Criteria:

• Known history of liver or kidney disease, diabetes, hypertension, stroke or myocardial infarctions, thyroid disease, gastrointestinal disease, AIDS or AIDS-related complications; subjects using prescription medications or Natural Health Products; Subjects will be excluded if they have any condition which, in the opinion of the investigator, might jeopardize the health and safety of the subject or study personnel, or adversely affect the study results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Carbohydrate Noodles; 0g Konjac Noodles	Dietary supplement: Konjac noodles; Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal); Other Names: Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Dietary supplement: Carbohydrate and Konjac Noodles; Other Names: Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015; Dietary supplement: Carbohydrate noodles; Other Names: Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015
Experimental: Carbohydrate and Konjac Noodles; Half Carbohydrate and Half Non-Caloric Konjac Noodles - 122.5g Konjac	Dietary supplement: Konjac noodles; Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal); Other Names: Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Dietary supplement: Carbohydrate and Konjac Noodles; Other Names: Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015; Dietary supplement: Carbohydrate noodles; Other Names: Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015
Experimental: Konjac Noodles; Non-Caloric Konjac Noodles (viscous gel meal) - 240g Konjac	Dietary supplement: Konjac noodles; Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal); Other Names: Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Dietary supplement: Carbohydrate and Konjac Noodles; Other Names: Konnyaku - Konjac Noodles; Wellbond Import export; Scarborough, Ontario MIW 2P7; Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015; Dietary supplement: Carbohydrate noodles; Other Names: Capellini n°1; Barilla America Inc.; Bannockburn, Il 60015

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Satiety	Objective satiety will be measured through subsequent food intake. At each visit, participants will consume a pre-weighed snack (wafer cookies) that will be administered ad libitum at 90mins after consumption of the test meal. Subsequent food intake will be calculated by weighing the amount of the snack food left after consumption.	90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Satiety	At each visit, participants will record their subjective satiety ratings using a 100 mm visual analogue scale and these rating will be combined into a total subjective appetite score using the formula (Q1+Q2+(100-Q3)+Q4)/4.	90 minutes

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Vladimir Vuksan, PhD, Risk Factor Modification Centre - St. Michael's Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: February 15, 2013
• First Submitted That Met QC Criteria: June 9, 2013
• First Posted (Estimate): June 12, 2013

Study Record Updates

• Last Update Posted (Estimate): June 12, 2013
• Last Update Submitted That Met QC Criteria: June 9, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 10-353