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

NCT07703254 | Not Yet Recruiting

• 1 other identifier: FIB16 / 25NXCRR01
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

gum acacia; acacia fiber; prebiotic; gut health; microbiota

Outcome Measures

Primary Outcomes (2)

• Frequency of complete and spontaneous bowel movements

  Frequency of complete and spontaneous bowel movements (CSBMs), as assessed by the Bowel Habits Diary (BHD)

  Baseline to Day 56

• Stool consistency

  Stool consistency, as assessed by the Bristol Stool Scale (BSS). The BSS is a 7-item stool description and image scale that assesses the shape and consistency of stool. Scores range from 1 to 7, with higher scores indicating looser stool consistency and lower scores indicating harder stool consistency.

  Baseline to Day 56

Secondary Outcomes (8)

• Gut Microbiota Composition

  Baseline to Day 56

• Frequency of CSBMs

  Baseline to Day 28

• Stool Consistency

  Baseline to Day 28

• Digestive symptoms

  Baseline to Day 28 and Day 56

• Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL)

  Baseline to Day 28 and Day 56

Other Outcomes (24)

• Change from baseline to Day 28 between Acacia fiber (5g or 10g) and placebo in gut microbiota composition, as assessed by fecal microbiome shotgun sequencing

  Baseline to Day 28

• Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in short-chain fatty acids (SCFAs)

  Baseline to Day 28 and Day 56

• Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in lipopolysaccharides (LPS) and LPS binding proteins

  Baseline to Day 28 and Day 56

Study Arms (3)

Low-dose Acacia fiber

EXPERIMENTAL

Dietary Supplement: Low-dose Acacia fiber

High-dose Acacia fiber

EXPERIMENTAL

Dietary Supplement: High-dose Acacia fiber

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo powder

Interventions

Placebo powder DIETARY_SUPPLEMENT

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.

Placebo

Low-dose Acacia fiber DIETARY_SUPPLEMENT

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.

Low-dose Acacia fiber

High-dose Acacia fiber DIETARY_SUPPLEMENT

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.

High-dose Acacia fiber

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males and females aged between 30 and 60 years old, inclusive
• Body Mass Index (BMI) between 18.5 to 29.9 kg/m², inclusive
• Stable body weight defined as a \<5% change in body weight in the three months prior to baseline as assessed by the Qualified Investigator (QI)
• Participants must meet the following criteria of occasional constipation for the past 3 months. This will be assessed at screening and confirmed over a 2-week period prior to baseline:
• CSBMs per week AND either one of the following: at least 25% of Bowel Movements (BMs) are BSS type 1 or 2 OR straining for most of the BMs (≥50%), defined as 3 minutes or more during BM, as assessed by the QI
• OR,
• At least 50% of BMs are BSS type 1 and 2, as assessed by the QI
• OR,
• ≤ 3 CSBMs per week as assessed by the QI
• Low to moderate fiber intake, defined as \< 18 g per day for women and \< 22 g per day for men, as assessed by the Food Frequency Questionnaire (FFQ)
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening
• OR,
• Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity or intolerance, to study products
• Chronic constipation, as assessed by the QI
• Following a specific diet (e.g., vegetarian, paleo, ketogenic, carnivore)
• Colonoscopy within four weeks prior to baseline or during the study
• Gastrointestinal related sensitivities including gluten and lactose intolerance
• Current or history of any significant diseases of the gastrointestinal tract (e.g., irritable bowel syndrome, irritable bowel disease, gastrointestinal surgery) as assessed by the QI
• Unstable metabolic disease, autoimmune disease or chronic diseases as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 8.3.1)
• Type I diabetes
• Type II diabetes if on insulin treatment. Type II diabetics on stable medication for at least three months and an Hemoglobin A1c (HbA1c) of \<8.0% may be included after assessment by the QI on a case-by-case basis
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI

Sponsors & Collaborators

• Nexira: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Ontario, N5Y 5V6, Canada

Location

Study Officials

• David Crowley, MD

  KGK Science Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erin Lewis, PhD

CONTACT

1-226-242-4551; elewis@kgkscience.com

Damien Guillemet

CONTACT

+33 2 32 83 18 18; d.guillemet@nexira.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor representatives will be masked to randomization assignments and treatment groups during the conduct of the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 14, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Locations

CA (1)