Satiety Study of a Carbohydrate Meal to a Highly Viscous Gel Meal

Obesity Clinical Trial

— InGel  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01875627
• Other study ID #: 10-353
• Status: Completed
• Phase: Phase 1
• First received: February 15, 2013
• Last updated: June 9, 2013
• Start date: November 2010
• Est. completion date: January 2012

Study information

• Verified date: May 2013
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• Konjac noodles
Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)
• Carbohydrate and Konjac Noodles

• Carbohydrate noodles

Locations

Country	Name	City	State
Canada	Risk Factor 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	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	No
Secondary	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	No