Diet ModificationNCT03716479
Gum Acacia and Blood Glucose
A study testing Low Fiber and High Fiber in people with Diet Modification, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet Modification
- What is being tested?
- Low Fiber and High Fiber
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2018to 1 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
Show all 9Show fewer
- do not normally eat breakfast or lunch;
- pregnant or lactating;
- irregular menstrual cycles.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Food Science and Nutrition
Saint Paul, Minnesota, 55108
About this study
Official title: 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.
Read the detailed description
This is a randomized, single-blind, crossover, intervention study testing the satiety and blood glucose effects of the soluble fiber gum acacia.
- Conditions
- Diet Modification
- Being tested
- Low Fiber, High Fiber, Placebo/Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low FiberOther
20 g of acacia gum will be added to orange juice
High FiberOther
40 g of acacia gum will be added to orange juice
Placebo/ControlOther
No acacia gum will be added to orange juice.
| Study group | Role | What they receive |
|---|---|---|
| 0 fiber | Experimental | 0 grams fiber added to orange juice Receives: Other: Placebo/Control |
| low fiber | Experimental | 20 grams of acacia gum added to orange juice Receives: Other: Low Fiber |
| high fiber | Experimental | 40 grams of acacia gum added to orange juice Receives: Other: High Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood glucose levels
Blood will be taken via finger stick
Measured: 0, 30, 60, 120, 180, and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment
Appetite Sensation
Subjective visual analog scale (VAS) will be utilized to assess hunger, fullness and desire to eat
Measured: 15, 30, 45, 60, 90, 120, 180 and 240 minutes after breakfast; Area under the curve (AUC) will be calculated for each treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start9 Oct 2018
- Primary completion31 Aug 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet ModificationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- subjects will consume 0, and 2 doses of acacia gum
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03716479
- Sponsor's protocol ID
- STUDY00004203
- Status last verified
- Oct 2019
- First submitted
- 29 Aug 2018
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Gum Acacia on Satiety, Glycemic Response and Gastrointestinal Tolerance
- ClinicalTrials.gov ID
- NCT03716479
- Acronym / sponsor ID
- STUDY00004203
- Conditions
- Diet Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 23 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- subjects will consume 0, and 2 doses of acacia gum
| Arm | Type | Receives |
|---|---|---|
| 0 fiber | Experimental | Other: Placebo/Control0 grams fiber added to orange juice |
| low fiber | Experimental | Other: Low Fiber20 grams of acacia gum added to orange juice |
| high fiber | Experimental | Other: High Fiber40 grams of acacia gum added to orange juice |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low Fiber20 g of acacia gum will be added to orange juice | Other | low fiber |
| High Fiber40 g of acacia gum will be added to orange juice | Other | high fiber |
| Placebo/ControlNo acacia gum will be added to orange juice. | Other | 0 fiber |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Fiber and High Fiber in people with Diet Modification, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019; AzTrials last refreshed its copy on 6 Nov 2026.