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Completed

NCT Number: NCT01875627

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

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Risk Factor Modification Centre

Toronto, Ontario, M5B1W8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Konjac noodles

Dietary Supplement

Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)

Other names: Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7

Carbohydrate and Konjac Noodles

Dietary Supplement

Other names: Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7, Capellini n°1, Barilla America Inc., Bannockburn, Il 60015

Carbohydrate noodles

Dietary Supplement

Other names: Capellini n°1, Barilla America Inc., Bannockburn, Il 60015

Primary outcomes

  1. Objective Satiety

    Time frame: 90 minutes

    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.

Secondary outcomes

  1. Subjective Satiety

    Time frame: 90 minutes

    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.

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Official study 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.

Acronym: InGel

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 12, 2013
Registry last updated
Jun 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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