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

NCT ID: NCT04547790

Last Updated: 2024-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-23
• Study Completion Date: 2023-11-27

Brief Summary

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.

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.

Conditions

Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Psyllium

Intervention Type: DIETARY_SUPPLEMENT

One level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water

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.

Group Type: EXPERIMENTAL

Wheat Dextrin

Intervention Type: DIETARY_SUPPLEMENT

One level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water

Interventions

Psyllium

One level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water

Intervention Type: DIETARY_SUPPLEMENT

Wheat Dextrin

One level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Metamucil; Benefiber

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Stephen L. Kopecky

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen Kopecky, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

19-010612

Identifier Type: -

Identifier Source: org_study_id