A Clinical Trial to Evaluate the Effects of a Fibre Supplement on Microbiome and Gut Health

N/AActive Not RecruitingNCT07781488

Artah Nutrition Limited50 enrolled

Overview

This study will evaluate the effects of the Artah Essential Fibre+ supplement on the microbiome and gut health over an 8-week period. The study is a single-arm, unblinded virtual trial enrolling 50 participants who will consume the test product daily and complete questionnaires at Baseline, Week 2, Week 4, Week 6, and Week 8. A subgroup of 30 participants will provide stool samples for microbiome testing at Baseline and Week 8. All participants will provide body composition measurements using a smart scale at Baseline, Week 4, and Week 8. Secondary outcomes include participants' self-reported perceptions of the product's effects on gut health, metabolism, food cravings, appetite, and general well-being.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Gut Health Microbiome Bloating Indigestion Constipation

Interventions

Essential Fibre+DIETARY_SUPPLEMENT

All 50 participants receive the Artah Essential Fibre+ supplement once daily in the morning before the first meal of the day, mixed with 500ml of water. Dosing is graduated: one scoop on Days 1-3, two scoops on Days 4-6, and three scoops from Day 7 onwards for the remainder of the 8-week study period.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female * Aged 21-65 * Experiencing issues regarding at least two of the following over the past four weeks: stomach discomfort, constipation, bowel movement regularity, indigestion, diarrhea, bloating, gas, abdominal pain, or excessive food cravings * Generally healthy - does not live with any uncontrolled chronic disease * If taking any other supplements or herbal remedies that target gut or digestive health, has been doing so for at least three months consistently, and is willing to maintain this for the duration of the study * Willing to maintain their current diet, sleep pattern, and activity levels for the duration of the study * Resides in the United States Exclusion Criteria: * Anyone unwilling to comply with the study protocol for the duration of the study * Anyone with a known history of severe digestive disorders like acid reflux, Irritable Bowel Syndrome (IBS), Irritable Bowel Disease (IBD), Crohn's disease, ulcerative colitis (UC), celiac disease, or gastrointestinal tract surgeries * Anyone with known allergies or hypersensitivities to any supplement product ingredients, including sesame and mustard * Anyone planning to introduce any other new supplements, prescription medications, or herbal remedies at any point for the duration of the study * Anyone with chronic health conditions that could impact participation in this study, such as cancer, mental health disorders, a history of serious illness in the last three months, history of substance abuse, or planned surgery during the study period * Anyone who has taken prescription antibiotics, prebiotics, synbiotics, postbiotics, and/or fiber supplements within the past three months * Has taken weight loss medications (like GLP-1 agonists) in the past three months * Anyone currently pregnant, trying to conceive, or breastfeeding * Anyone currently testing, or planning to test, a product during the course of the study

Outcomes

Primary Outcomes

Change in Gut Resilience Score

Change from Baseline in Gut Resilience Score assessed via stool-based microbiome testing (Tiny Health)