Effects of Resistant Potato Starch on the Gut Microbiota

Manitoba Starch Products

Status: Completed

Conditions: Microbiota

Treatments: Dietary Supplement: Resistant Potato Starch; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05242913

R10356

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

High Dose SolnulTM

Active Comparator group

Description:

7.0 g of Resistant Potato Starch administered daily for 4 weeks

Treatment:

Dietary Supplement: Resistant Potato Starch

Low Dose SolnulTM

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: Resistant Potato Starch

Placebo

Placebo Comparator group

Description:

7.0 g digestible corn starch administered daily for 4 weeks

Treatment:

Dietary Supplement: Placebo