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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
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.
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.
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.
KGK Science Inc.
London, Ontario, Canada
Frequency of complete and spontaneous bowel movements
Frequency of complete and spontaneous bowel movements (CSBMs), as assessed by the Bowel Habits Diary (BHD)
Time frame: 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.
Time frame: Baseline to Day 56
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
Time frame: Baseline to Day 56
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
Time frame: Baseline to Day 28
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.
Time frame: Baseline to Day 28
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.
Time frame: Baseline to Day 28 and Day 56
Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL)
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in Quality of life as assessed by Patient Assessment of Constipation Quality of Life questionnaire (PAC-QoL). The PAC-QoL consists of 28-items with four subscales (worries and concerns, physical discomfort, psychosocial discomfort, and satisfaction), and an overall scale. Items are scored on a 5-point Likert scale ranging from 0 to 4, with lower scores indicating better constipation-related quality of life.
Time frame: Baseline to Day 28 and Day 56
Proportion of CSBMs with complete defecation
The difference in the proportion of CSBMs with complete defecation at Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo
Time frame: Day 28 and Day 56
proportion of participants with occasional constipation
The difference in the proportion of participants with occasional constipation at Day 56 between Acacia fiber (5g or 10g) and placebo
Time frame: Day 56
Sleep and Stress
Change from baseline to Day 28 and Day 56 between Acacia fiber (5g or 10g) and placebo in sleep and stress, as assessed by the sleep and stress Likert scales. Four-point Likert scales will be used to measure the participant's perceived sleep quality (strongly disagree - 0, disagree - 1, agree - 2, strongly agree - 3) and stress (no stress - 0, minimally stressed - 1, moderately stressed - 2, extremely stressed - 3). Participants will be instructed to indicate their response on the scale for the following statements: "Overall, I am satisfied with my sleep" and " Rate your current stress level". Higher scores indicate greater perceived stress.
Time frame: Baseline to Day 28 and Day 56
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