Recruiting
Phase 1

Viscous Fibre

Sponsor:

Unity Health Toronto

Code:

NCT02134938

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Konjac Glucomannan

Study Details

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.

Conditions

Obesity

Study ID

NCT02134938

Start date

Jul, 2013

Status verified date

Apr, 2014

Primary completion date

Sep, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Konjac Glucomannan

650g KJM-G

experimental: Half Control/Half Konjac Glucomannan

325g KJM-G

no intervention: Control

0g KJM-G

Interventions

Konjac Glucomannan

Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes

Primary outcome measure

  • Subjective Satiety [ Time Frame: 12 hours for each of the 3 study visits. ]

Central Contacts and Locations

Central contacts

Rodney Au-Yeung, BSc

(416) 864-6060auyeungf@smh.ca

Locations

Clinical Risk Factor and Modification Centre

Recruiting

Toronto, Ontario, Canada, M5C 2T2

More Information

Sponsor

Unity Health Toronto

Last update posted

May 9, 2014

Last verified

Apr, 2014

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Unity Health Toronto on 2014-05-09.