- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03716479
Gum Acacia and Blood Glucose
October 3, 2019 updated by: University of Minnesota
The Effect of Gum Acacia on Satiety, Glycemic Response and Gastrointestinal Tolerance
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Saint Paul, Minnesota, United States, 55108
- Department of Food Science and Nutrition
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 0 fiber
0 grams fiber added to orange juice
|
No acacia gum will be added to orange juice.
|
Experimental: low fiber
20 grams of acacia gum added to orange juice
|
20 g of acacia gum will be added to orange juice
|
Experimental: high fiber
40 grams of acacia gum added to orange juice
|
40 g of acacia gum will be added to orange juice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
0, 30, 60, 120, 180, and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment
|
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
|
15, 30, 45, 60, 90, 120, 180 and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2018
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
September 1, 2019
Study Registration Dates
First Submitted
August 29, 2018
First Submitted That Met QC Criteria
October 16, 2018
First Posted (Actual)
October 23, 2018
Study Record Updates
Last Update Posted (Actual)
October 4, 2019
Last Update Submitted That Met QC Criteria
October 3, 2019
Last Verified
October 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- STUDY00004203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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