NCT05242913

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 30, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 6, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 27, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 16, 2022

Completed
Last Updated

February 16, 2022

Status Verified

February 1, 2022

Enrollment Period

2 months

First QC Date

January 27, 2022

Last Update Submit

February 7, 2022

Conditions

Microbiota

Keywords

MicrobiotaResistant Potato StarchBristol Stool ChartDiarrheaConstipationBloatingAbdominal PainGasWell-being

Outcome Measures

Primary Outcomes (1)

  • Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups

    Changes in relative abundance of Bifidobacterium after 4 weeks of consumption in High Dose, Low Dose, and placebo arms are compared.

    Four weeks

Secondary Outcomes (5)

  • Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool between treatment groups

    One week

  • Changes in relative abundance (% of gut microbiome) of Bifidobacterium from stool within treatment groups

    One week, four weeks

  • Fecal SCFA (mmol/kg stool) changes from baseline

    One week, four weeks

  • Changes from baseline in stool consistency using self-reported Bristol Stool Chart scores

    One week, four weeks

  • Changes from baseline in gastrointestinal symptoms using the a modified Gastrointestinal Quality of Life Index scale

    One week, four weeks

Study Arms (3)

High Dose SolnulTM

ACTIVE COMPARATOR

7.0 g of Resistant Potato Starch administered daily for 4 weeks

Dietary Supplement: Resistant Potato Starch

Low Dose SolnulTM

ACTIVE COMPARATOR

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

Dietary Supplement: Resistant Potato Starch

Placebo

PLACEBO COMPARATOR

7.0 g digestible corn starch administered daily for 4 weeks

Dietary Supplement: Placebo

Interventions

Resistant Potato StarchDIETARY_SUPPLEMENT

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

Also known as: Solnul, MSPrebiotic
High Dose SolnulTMLow Dose SolnulTM
PlaceboDIETARY_SUPPLEMENT

Fully digestible corn starch

Also known as: AmiocaTM
Placebo

Eligibility Criteria

Age18 Years - 69 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Diagnosis of Irritable Bowel Syndrome (IBS), dyspepsia, significant gastrointestinal disorders, or other major diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nutrasource Pharmaceutical and Nutraceutical Services

Guelph, Ontario, N1G 0B4, Canada

Location

Related Publications (1)

  • 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.

    PMID: 39605008DERIVED

MeSH Terms

Conditions

DiarrheaConstipationAbdominal PainMucopolysaccharidosis IV

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsMucopolysaccharidosesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLysosomal Storage DiseasesMucinosesConnective Tissue DiseasesSkin and Connective Tissue DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Anthony Beir, MD

    Nutrasource Pharmaceutical and Nutraceutical Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2022

First Posted

February 16, 2022

Study Start

October 30, 2019

Primary Completion

January 6, 2020

Study Completion

January 6, 2020

Last Updated

February 16, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)