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
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)
5 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
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)
Parallel
Placebo powder
Dietary supplementStarting 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
Dietary supplementStarting 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
Dietary supplementStarting 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.
Frequency of complete and spontaneous bowel movements
Frequency of complete and spontaneous bowel movements (CSBMs), as assessed by the Bowel Habits Diary (BHD)
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.
Gut Microbiota Composition
Change from baseline to Day 56 between Acacia fiber (5g or 10g) and placebo in gut microbiota composition, as assessed by fecal microbiome shotgun sequencing
Frequency of CSBMs
Change from baseline to Day 28 between Acacia fiber (5g or 10g) and placebo in frequency of CSBMs, as assessed by the BHD
Stool Consistency
Change from baseline to Day 28 between Acacia fiber (5g or 10g) and placebo in 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.
Digestive symptoms
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in digestive symptoms as assessed by Gastrointestinal Symptom Rating Scale (GSRS). The modified GSRS consists of 14 items on a four-point scale (0-3). It assesses abdominal pain, reflux syndrome, diarrhea syndrome, indigestion syndrome, and constipation syndrome. Higher scores indicate more severe gastrointestinal symptoms.
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
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
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in short-chain fatty acids (SCFAs)
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in constipation related fecal biomarkers (short-chain fatty acids (SCFAs).
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in lipopolysaccharides (LPS) and LPS binding proteins
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in constipation related fecal biomarkers (lipopolysaccharides (LPS) and LPS binding proteins).
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in primary and secondary bile acids
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in constipation related fecal biomarkers (primary and secondary bile acids).
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Nexira
Lead sponsor
KGK Science Inc.
Collaborator
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