NCT01875627

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 obesity

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 12, 2013

Completed
Last Updated

June 12, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

February 15, 2013

Last Update Submit

June 9, 2013

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Subjective Satiety

    90 minutes

Study Arms (3)

Carbohydrate Noodles

PLACEBO COMPARATOR

0g Konjac Noodles

Dietary Supplement: Konjac noodlesDietary Supplement: Carbohydrate and Konjac NoodlesDietary Supplement: Carbohydrate noodles

Carbohydrate and Konjac Noodles

EXPERIMENTAL

Half Carbohydrate and Half Non-Caloric Konjac Noodles - 122.5g Konjac

Dietary Supplement: Konjac noodlesDietary Supplement: Carbohydrate and Konjac NoodlesDietary Supplement: Carbohydrate noodles

Konjac Noodles

EXPERIMENTAL

Non-Caloric Konjac Noodles (viscous gel meal) - 240g Konjac

Dietary Supplement: Konjac noodlesDietary Supplement: Carbohydrate and Konjac NoodlesDietary Supplement: Carbohydrate noodles

Interventions

Konjac noodlesDIETARY_SUPPLEMENT

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

Also known as: Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7
Carbohydrate NoodlesCarbohydrate and Konjac NoodlesKonjac Noodles
Carbohydrate and Konjac NoodlesDIETARY_SUPPLEMENT
Also known as: Konnyaku - Konjac Noodles, Wellbond Import export, Scarborough, Ontario MIW 2P7, Capellini n°1, Barilla America Inc., Bannockburn, Il 60015
Carbohydrate NoodlesCarbohydrate and Konjac NoodlesKonjac Noodles
Carbohydrate noodlesDIETARY_SUPPLEMENT
Also known as: Capellini n°1, Barilla America Inc., Bannockburn, Il 60015
Carbohydrate NoodlesCarbohydrate and Konjac NoodlesKonjac Noodles

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Risk Factor Modification Centre

Toronto, Ontario, M5B1W8, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

Carbohydrates

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vladimir Vuksan, PhD

    Risk Factor Modification Centre - St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 15, 2013

First Posted

June 12, 2013

Study Start

November 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

June 12, 2013

Record last verified: 2013-05

Locations

CA(1)