A Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation

Summary

The goal of this randomized blinded placebo-controlled clinical trial is to investigate the effect of low- and high-dose supplementation of Acacia fiber on gut health and microbiota composition in adults with occasional constipation in a controlled diet context. Acacia fiber is a soluble dietary fiber with prebiotic properties, and this study evaluates its role in modulating gut microbiota and associated gastrointestinal outcomes. Acacia fiber has previously demonstrated improvements in stool frequency in the context of an irritable bowel syndrome with constipation (IBS-C)-characterized population. The main questions this study aims to answer are: Does Acacia fiber supplementation (5 g or 10 g) improve the frequency of bowel movements or stool consistency (assessed by Bristol Stool Scale) in the context of healthy population with occasional constipation? Does Acacia fiber benefit on gut health correlates with specific gut microbiota modulation characterised by shotgun sequencing? What are mechanistical faecal \& blood markers that may support this correlation? Researchers will compare low-dose Acacia fiber (5 g), high-dose Acacia fiber (10 g), and placebo to see if Acacia fiber modulates gut microbiota composition in a manner consistent with prebiotic activity and whether these changes are associated with improvements in bowel movement frequency and stool consistency. Participants will:

* Take a daily supplement of either 5 g Acacia fiber, 10 g Acacia fiber, or placebo
* Complete study diaries, including the Bowel Habits Diary and Bristol Stool Scale
* Complete the Patient Assessment of Constipation Quality of Life, modified Gastrointestinal Symptoms Rating Scale, and sleep and stress Likert scales
* Complete 3-day food records

Conditions

• Occasional Constipation
• Gastrointestinal Health
• Gut Microbiota Composition

Interventions

DIETARY_SUPPLEMENT

Placebo powder

Starting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption.

DIETARY_SUPPLEMENT

Low-dose Acacia fiber

Starting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption.

DIETARY_SUPPLEMENT

High-dose Acacia fiber

Starting the day following the baseline visit (Day 1), participants will take 1 sachet daily for 4 days, then increase to 2 sachets daily until the day prior to the end-of-study visit (Day 56). Each sachet will be mixed with a usual food or beverage prior to consumption.

Sponsors & Collaborators

• KGK Science Inc.

  collaborator INDUSTRY

• Nexira

  lead INDUSTRY

Principal Investigators

• David Crowley, MD · KGK Science Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

30 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-31

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Canada

Study Locations