Abdominal Discomfort, Bloating, Bowel Movement Irregularity, Constipation, Diarrhea, Food Cravings, Gut Health, Indigestion, Microbiome
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTEssential Fibre+
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.
Sponsors
Artah Nutrition Limited
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gut Resilience Score | Baseline and Week 8 | Change from Baseline in Gut Resilience Score assessed via stool-based microbiome testing (Tiny Health) |
| Change in Hydrogen Sulfide Index | Baseline and Week 8 | Change from Baseline in Hydrogen Sulfide Index assessed via stool-based microbiome testing (Tiny Health) |
| Change in Firmicutes/Bacteroidota Ratio | Baseline and Week 8 | Change from Baseline in Firmicutes/Bacteroidota ratio assessed via stool-based microbiome testing (Tiny Health) |
| Change in Hexa-LPS Index | Baseline and Week 8 | Change from Baseline in Hexa-LPS Index assessed via stool-based microbiome testing (Tiny Health) |
| Change in Mucus Degradation Index | Baseline and Week 8 | Change from Baseline in Mucus Degradation Index assessed via stool-based microbiome testing (Tiny Health) |
| Change in Prevotella Abundance | Baseline and Week 8 | Change from Baseline in Prevotella abundance assessed via stool-based microbiome testing (Tiny Health) |
| Change in Bacteroides Abundance | Baseline and Week 8 | Change from Baseline in Bacteroides abundance assessed via stool-based microbiome testing (Tiny Health) |
| Change in Abundance Index | Baseline and Week 8 | Change from Baseline in Abundance Index assessed via stool-based microbiome testing (Tiny Health) |
| Change in Richness Index | Baseline and Week 8 | Change from Baseline in Richness Index assessed via stool-based microbiome testing (Tiny Health) |
| Change in Proteobacteria/Actinobacteriota Ratio | Baseline and Week 8 | Change from Baseline in Proteobacteria/Actinobacteriota ratio assessed via stool-based microbiome testing (Tiny Health) |
| Change in Butyrate Level | Baseline and Week 8 | Change from Baseline in Butyrate level assessed via stool-based microbiome testing (Tiny Health) |
| Change in Acetate Level | Baseline and Week 8 | Change from Baseline in Acetate level assessed via stool-based microbiome testing (Tiny Health) |
| Change in Propionate Level | Baseline and Week 8 | Change from Baseline in Propionate level assessed via stool-based microbiome testing (Tiny Health) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Self-Reported Indigestion | Baseline, Week 2, Week 4, Week 6, and Week 8 | Change from Baseline in participant-reported indigestion assessed via self-report questionnaire |
| Change in Self-Reported Bloating | Baseline, Week 2, Week 4, Week 6, and Week 8 | Change from Baseline in participant-reported bloating assessed via self-report questionnaire |
| Change in Self-Reported Bowel Movement Frequency | Baseline, Week 2, Week 4, Week 6, and Week 8 | Change from Baseline in participant-reported bowel movement frequency assessed via self-report questionnaire |
| Change in Self-Reported Food Cravings | Baseline, Week 2, Week 4, Week 6, and Week 8 | Change from Baseline in participant-reported food cravings assessed via self-report questionnaire |
| Change in Self-Reported Overall Mood | Baseline, Week 2, Week 4, Week 6, and Week 8 | Change from Baseline in participant-reported overall mood assessed via self-report questionnaire |
Countries
United States
Outcome results
None listed