Citruslabs
Las Vegas, Nevada, 89101, United States
NCT Number: NCT07781488
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.
This study is active but is not currently recruiting participants.
Notify Me21 year–65 year
All sexes
Interventional
Not applicable
Las Vegas, Nevada, 89101, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline and Week 8
Change from Baseline in Gut Resilience Score assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Hydrogen Sulfide Index assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Firmicutes/Bacteroidota ratio assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Hexa-LPS Index assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Mucus Degradation Index assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Prevotella abundance assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Bacteroides abundance assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Abundance Index assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Richness Index assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Proteobacteria/Actinobacteriota ratio assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Butyrate level assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Acetate level assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline and Week 8
Change from Baseline in Propionate level assessed via stool-based microbiome testing (Tiny Health)
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change from Baseline in participant-reported indigestion assessed via self-report questionnaire
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change from Baseline in participant-reported bloating assessed via self-report questionnaire
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change from Baseline in participant-reported bowel movement frequency assessed via self-report questionnaire
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change from Baseline in participant-reported food cravings assessed via self-report questionnaire
Time frame: Baseline, Week 2, Week 4, Week 6, and Week 8
Change from Baseline in participant-reported overall mood assessed via self-report questionnaire
Artah Nutrition Limited
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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