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Gum Acacia and Blood Glucose

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716479
Recruitment Status : Completed
First Posted : October 23, 2018
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE August 29, 2018
First Posted Date  ICMJE October 23, 2018
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE October 9, 2018
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 16, 2018)
  • Blood glucose levels [ Time Frame: 0, 30, 60, 120, 180, and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment ]
    Blood will be taken via finger stick
  • Appetite Sensation [ Time Frame: 15, 30, 45, 60, 90, 120, 180 and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment ]
    Subjective visual analog scale (VAS) will be utilized to assess hunger, fullness and desire to eat
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gum Acacia and Blood Glucose
Official Title  ICMJE The Effect of Gum Acacia on Satiety, Glycemic Response and Gastrointestinal Tolerance
Brief Summary This study will provide needed insight on the satiety and blood glucose and l effects of the soluble fiber gum acacia at 20g and 40g doses.
Detailed Description This is a randomized, single-blind, crossover, intervention study testing the satiety and blood glucose effects of the soluble fiber gum acacia.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
subjects will consume 0, and 2 doses of acacia gum
Masking: Double (Participant, Investigator)
Masking Description:
fiber will be mixed into orange juice
Primary Purpose: Prevention
Condition  ICMJE Diet Modification
Intervention  ICMJE
  • Other: Low Fiber
    20 g of acacia gum will be added to orange juice
  • Other: High Fiber
    40 g of acacia gum will be added to orange juice
  • Other: Placebo/Control
    No acacia gum will be added to orange juice.
Study Arms  ICMJE
  • Experimental: 0 fiber
    0 grams fiber added to orange juice
    Intervention: Other: Placebo/Control
  • Experimental: low fiber
    20 grams of acacia gum added to orange juice
    Intervention: Other: Low Fiber
  • Experimental: high fiber
    40 grams of acacia gum added to orange juice
    Intervention: Other: High Fiber
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2018)
48
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 1, 2019
Actual Primary Completion Date August 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria: BMI between 18 and 29 kg/m2

Exclusion Criteria:

  • distaste for bagels and cream cheese, orange juice or cheese pizza;
  • current smoker;
  • restrained eating habits;
  • recent weight change;
  • any history of disease or significant past medical history;
  • are vegetarian;
  • do not normally eat breakfast or lunch;
  • pregnant or lactating;
  • irregular menstrual cycles.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03716479
Other Study ID Numbers  ICMJE STUDY00004203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP