NCT04547790

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 23, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2023

Completed
Last Updated

March 28, 2024

Status Verified

March 1, 2024

Enrollment Period

2.9 years

First QC Date

September 8, 2020

Last Update Submit

March 27, 2024

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Change in fasting blood sugar

    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

    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 Outcomes (4)

  • Change in LDL-C

    12 weeks

  • Change in ceramides

    12 weeks

  • Change in blood pressure

    12 weeks

  • Change in weight

    12 weeks

Study Arms (2)

Psyllium group

EXPERIMENTAL

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

Wheat Dextrin group

EXPERIMENTAL

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

Interventions

PsylliumDIETARY_SUPPLEMENT

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

Also known as: Metamucil
Psyllium group
Wheat DextrinDIETARY_SUPPLEMENT

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

Also known as: Benefiber
Wheat Dextrin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Interventions

Psyllium

Intervention Hierarchy (Ancestors)

Plant ExtractsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Stephen Kopecky, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 14, 2020

Study Start

December 23, 2020

Primary Completion

November 27, 2023

Study Completion

November 27, 2023

Last Updated

March 28, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)