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

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ClinicalTrials.gov Identifier: NCT02134938
Recruitment Status : Unknown
Verified April 2014 by Unity Health Toronto.
Recruitment status was:  Recruiting
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Unity Health Toronto

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.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Konjac Glucomannan Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of High-Fibre, Low-Energy Density Viscous Gel Meals on Satiety, Appetite Regulation and Subsequent Food Intake in Healthy Individuals
Study Start Date : July 2013
Estimated Primary Completion Date : September 2014

Arm Intervention/treatment
Experimental: Konjac Glucomannan
650g KJM-G
Dietary Supplement: Konjac Glucomannan
Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes

Experimental: Half Control/Half Konjac Glucomannan
325g KJM-G
Dietary Supplement: Konjac Glucomannan
Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes

No Intervention: Control
0g KJM-G



Primary Outcome Measures :
  1. Subjective Satiety [ Time Frame: 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 Outcome Measures :
  1. Ambulatory Blood Pressure [ Time Frame: Measured at the beginning of each of the 3 study visits and every 30 minutes thereafter until 10:00pm the same day. ]
  2. Height and Weight [ Time Frame: Taken once at the beginning of each of the 3 clinical visits. ]
  3. Blood Samples [ Time Frame: 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.

  4. Palatability Scores [ Time Frame: 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. ]
  5. Food Craving Rating [ Time Frame: 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.

  6. Subsequent Food Intake [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134938


Contacts
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Contact: Rodney Au-Yeung, BSc (416) 864-6060 ext 5526 auyeungf@smh.ca

Locations
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Canada, Ontario
Clinical Risk Factor and Modification Centre Recruiting
Toronto, Ontario, Canada, M5C 2T2
Sponsors and Collaborators
Unity Health Toronto
Investigators
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Principal Investigator: Vladimir Vuksan, PhD Risk Factor Modification Centre - St. Michael's Hospital
Principal Investigator: Alexandra Jenkins (Co-Investigator), RD, PhD Risk Factor Modification Centre - St. Michael's Hospital
Principal Investigator: William Watson (Qualified Investigator), MD Department of Family Medicine - St. Michael's Hospital
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Responsible Party: Unity Health Toronto
ClinicalTrials.gov Identifier: NCT02134938    
Other Study ID Numbers: KJM-G
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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(1-6)-alpha-glucomannan
Cathartics
Gastrointestinal Agents