Acacia Fiber for Constipation

EL
DG
Overseen ByDamien Guillemet
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Nexira

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

DC

David Crowley, MD

Principal Investigator

KGK Science Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults who experience occasional constipation. People with chronic digestive diseases or on medications affecting gut health are likely excluded.

Inclusion Criteria

Agrees to maintain current lifestyle habits (diet, sleep, physical activity, medications, supplements) as much as possible throughout study
Body Mass Index (BMI) between 18.5 to 29.9 kg/m², inclusive
Stable body weight defined as less than 5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)
See 7 more

Exclusion Criteria

Individuals who are pregnant, breastfeeding, or planning pregnancy during study
Allergy, sensitivity or intolerance to study products
I have ongoing constipation, as measured by a questionnaire.
See 27 more

What Are the Treatments Tested in This Trial?

Interventions

  • Acacia fiber

Trial Overview

The study tests daily supplements of low-dose (5g) and high-dose (10g) Acacia fiber versus a placebo powder to see if they improve bowel movement frequency, stool consistency, and gut bacteria in people with occasional constipation.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: Low-dose Acacia fiberExperimental Treatment1 Intervention
Group II: High-dose Acacia fiberExperimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nexira

Lead Sponsor

Trials
8
Recruited
2,900+

KGK Science Inc.

Industry Sponsor

Trials
82
Recruited
6,400+

Najla Guthrie

KGK Science Inc.

Chief Executive Officer since 1997

Research career at the Centre for Human Nutrition, University of Western Ontario

Dr. Bibiane Zakaria

KGK Science Inc.

Chief Medical Officer since 2023

MD from an unspecified institution