A Study to Assess the Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markets in Diabetes Mellitus 2

March 27, 2024 updated by: Stephen L. Kopecky, Mayo Clinic

Fiber and Diabetes (FAD) Study: Effect of Psyllium vs. Wheat Dextrin on Glycemic Control and Inflammatory Markers in DM2

The purpose of this study is to determine which of Psyllium and Wheat Dextrin is more effective in lowering fasting blood sugar and hemoglobin A1c, and to evaluate the effects they have on laboratory values.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients identified as Type 2 diabetics will be identified via Mayo's electronic data system and verified by review of their medical record. Study coordinators will then send invitation letters to patients who meet initial inclusion criteria via mail or through the Mayo Patient Online Services (i.e. patient portal). Recruitment tools used will be flyer, an internet web posting, and a Mayo classified research ad placed in the Mayo classifieds. If patients are interested in participating, they will call or email the study coordinators to set up their baseline visit. Non-responders will be called up to 3 times if no answer. The study coordinator will ask if they received the letter and if they have any questions and if they are interested in participating.

Potential subjects will be screened and consented either digitally or via paper. After consent, the study coordinator will complete the subject's medical history, review concomitant medications, and record vital signs during the baseline visit. Subjects will be randomized and instructed to complete a baseline blood draw, after which they will be given a 3-month supply of study product, a dosing scoop for the product and instructions on taking the assigned study product. They will be assigned to take the study product once daily for the first three days, then twice daily starting Day 4 until the end of the study.

Subjects will be asked to respond to a text message or email message, daily, asking how many doses of study medication they took for that day (0, 1 or 2). The study coordinator will also contact subjects by phone or email to review and reinforce adherence to the protocol if the survey research center identifies subjects who have not responded to text messages within 3 days.

Subjects will meet with study coordinators in person at 4, 8, and 12 weeks or study end to collect vitals, perform a symptom check, review concomitant medications, complete blood draws, and reinforce adherence to protocol.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
101

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Subject population: This will include adult ECH patients (18 years of age or older) with DM2 who receive their care and diabetic management through Primary Care in Rochester at Mayo Clinic.

Inclusion Criteria:

  • Age >18
  • May be on oral therapy (including metformin) or insulin
  • Most recent HgbA1c level measuring between 6.5 -10 within the last 3 months
  • May be on stable (> 4 weeks) statin dose or no statin therapy
  • Willing to sign informed consent and stay on current medical regimen
  • Does not use regular dietary fiber supplements; has not had any psyllium containing products in the previous 30 days; is willing to refrain from taking any other fiber containing supplement products during the study
  • Has not used systemic steroid agents in the last 30 days
  • Able to participate fully in all aspects of the study
  • Have access and ability to utilize text messaging or email

Exclusion Criteria:

  • Unwilling/unable to participate
  • Comorbid inflammatory bowel disease, celiac sprue, nephrotic syndrome, severe cholestasis (e.g., primary biliary cirrhosis), or history of bariatric surgery/bowel resection
  • Alcohol use in excess of 14 drinks/week
  • Allergic reactions to psyllium or wheat dextrin
  • Has participated in a clinical drug study or used an investigational new drug during the previous 30 days
  • Self-Report of known or suspected pregnancy or immediate plans (within 3 months) of becoming pregnant
  • Currently breastfeeding
  • Has a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
  • Anticipated or recent major changes in diet or exercise routine
  • Anticipated colonoscopy prep during 3 months of study period

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psyllium group
Subjects will take psyllium once daily for the first three days, then twice daily starting Day 4 until the end of the study.
Dietary supplement: Psyllium
One level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water
Other Names:
  • Metamucil
Experimental: Wheat Dextrin group
Subjects will take wheat dextrin once daily for the first three days, then twice daily starting Day 4 until the end of the study.
Dietary supplement: Wheat Dextrin
One level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water
Other Names:
  • Benefiber

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in fasting blood sugar
Time Frame: 12 weeks
The two endpoints of primary interest for this study are HbA1c and fasting glucose. The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate.
12 weeks
Change in HbA1c
Time Frame: 12 weeks
The primary analysis will assess the change in these endpoints between the two treatment groups over the 12 week study period. To estimate the difference between study groups a linear mixed model will be used to account for repeated measures of subjects. The independent variable will be Psyllium group and the baseline outcome result will be included as a covariate.
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in LDL-C
Time Frame: 12 weeks
As a secondary analysis, LDL-C, will be collected and analyzed. to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
12 weeks
Change in ceramides
Time Frame: 12 weeks
As a secondary analysis, ceramides will be collected and analyzed to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
12 weeks
Change in blood pressure
Time Frame: 12 weeks
Blood pressure will be collected and analyzed. For vital signs measurements a paired t-test will be used to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
12 weeks
Change in weight
Time Frame: 12 weeks
Weight will be collected and analyzed. For vital signs measurements a paired t-test will be used to determine any difference between the two groups. The blood chemistry labs will be analyzed using a linear mixed model with the given outcome variable included as a covariate.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Stephen Kopecky, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-010612

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

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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