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

NCT07781488 | Active Not Recruiting

• 2 other identifiers: #20825legacy-_20825
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gut Health; Microbiome; Bloating; Indigestion; Constipation; Diarrhea; Food Cravings; Abdominal Discomfort; Bowel Movement Irregularity

Outcome Measures

Primary Outcomes (13)

• Change in Gut Resilience Score

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

  Baseline and Week 8

• Change in Hydrogen Sulfide Index

  Change from Baseline in Hydrogen Sulfide Index assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Firmicutes/Bacteroidota Ratio

  Change from Baseline in Firmicutes/Bacteroidota ratio assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Hexa-LPS Index

  Change from Baseline in Hexa-LPS Index assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Mucus Degradation Index

  Change from Baseline in Mucus Degradation Index assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Prevotella Abundance

  Change from Baseline in Prevotella abundance assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Bacteroides Abundance

  Change from Baseline in Bacteroides abundance assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Abundance Index

  Change from Baseline in Abundance Index assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Richness Index

  Change from Baseline in Richness Index assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Proteobacteria/Actinobacteriota Ratio

  Change from Baseline in Proteobacteria/Actinobacteriota ratio assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Butyrate Level

  Change from Baseline in Butyrate level assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Acetate Level

  Change from Baseline in Acetate level assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

• Change in Propionate Level

  Change from Baseline in Propionate level assessed via stool-based microbiome testing (Tiny Health)

  Baseline and Week 8

Secondary Outcomes (5)

• Change in Self-Reported Indigestion

  Baseline, Week 2, Week 4, Week 6, and Week 8

• Change in Self-Reported Bloating

  Baseline, Week 2, Week 4, Week 6, and Week 8

• Change in Self-Reported Bowel Movement Frequency

  Baseline, Week 2, Week 4, Week 6, and Week 8

• Change in Self-Reported Food Cravings

  Baseline, Week 2, Week 4, Week 6, and Week 8

• Change in Self-Reported Overall Mood

  Baseline, Week 2, Week 4, Week 6, and Week 8

Study Arms (1)

Essential Fibre+

EXPERIMENTAL

Dietary Supplement: Essential Fibre+

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.

Essential Fibre+

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Citruslabs: collaborator
• Artah Nutrition Limited: lead

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89101, United States

Location

MeSH Terms

Conditions

Dyspepsia; Constipation; Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 24, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 24, 2026

Record last verified: 2026-08

Locations

US (1)