Effects of Resistant Potato Starch on the Gut Microbiota

NCT ID: NCT05242913

Last Updated: 2022-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-30

Study Completion Date

2020-01-06

Brief Summary

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This was a randomized, double-blind, three-arm, parallel group clinical trial, which assessed the shifts that occur in microbial populations after four weeks of supplementation with resistant potato starch (SolnulTM) at two different dosages, in comparison to a placebo in healthy adults.

Detailed Description

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Conditions

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Microbiota

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High Dose SolnulTM

7.0 g of Resistant Potato Starch administered daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Resistant Potato Starch

Intervention Type DIETARY_SUPPLEMENT

Unmodified potato starch containing \>60% resistant starch Type 2

Low Dose SolnulTM

3.5 g of Resistant Potato Starch (plus 3.5 g digestible corn starch for 7.0 g total carbohydrate) administered daily for 4 weeks

Group Type ACTIVE_COMPARATOR

Resistant Potato Starch

Intervention Type DIETARY_SUPPLEMENT

Unmodified potato starch containing \>60% resistant starch Type 2

Placebo

7.0 g digestible corn starch administered daily for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Fully digestible corn starch

Interventions

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Resistant Potato Starch

Unmodified potato starch containing \>60% resistant starch Type 2

Intervention Type DIETARY_SUPPLEMENT

Placebo

Fully digestible corn starch

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Solnul MSPrebiotic AmiocaTM

Eligibility Criteria

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Inclusion Criteria

* BMI between 18.0 and 34.9 kg/square meter (inclusive) that were generally healthy as determined by medical history and screening blood work.

Exclusion Criteria

* Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MSP Starch Products Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anthony Beir, MD

Role: PRINCIPAL_INVESTIGATOR

Nutrasource Pharmaceutical and Nutraceutical Services

Locations

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Nutrasource Pharmaceutical and Nutraceutical Services

Guelph, Ontario, Canada

Site Status

Countries

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Canada

References

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Bush JR, Alfa MJ. Consumption of resistant potato starch produces changes in gut microbiota that correlate with improvements in abnormal bowel symptoms: a secondary analysis of a clinical trial. BMC Nutr. 2024 Nov 27;10(1):152. doi: 10.1186/s40795-024-00962-7.

Reference Type DERIVED
PMID: 39605008 (View on PubMed)

Other Identifiers

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R10356

Identifier Type: -

Identifier Source: org_study_id

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