← Back to all trials
Not Yet Recruiting
NCT07703254
A Clinical Trial to Investigate the Efficacy of Acacia Fiber on Gastrointestinal Health and Microbiota Composition in Healthy Adults With Occasional Constipation
Conditions: Occasional Constipation, Gastrointestinal Health, Gut Microbiota Composition
Sex: All
Ages: 30 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 105
Sponsor: Nexira
Location: KGK Science Inc. London Ontario
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
Eligibility Criteria
Inclusion Criteria:
* 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 \2 per day or \>10 per week of standard drinks as assessed by the QI
* Alcohol or drug abuse within the last 12 months
* Current use of prescribed and/or over-the-counter (OTC) medications, supplements, and/or consumption of food/drinks that may impact the efficacy and/or safety of the investigational product, gut transit and/or constipation, or gut microbiota characteristics (e.g., fibre, pre- pro- postbiotic, polyphenols extract, etc.) (Section 8.3)
* Clinically significant abnormal laboratory results at screening as assessed by the QI
* Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit
* Participation in other clinical research studies 60 days prior to baseline, as assessed by the QI
* Individuals who are unable to give informed consent
* Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant
Source: ClinicalTrials.gov (NCT07703254). StuddyBuddy aggregates publicly available trial information.