NCT07421596

An 8-Week Study Evaluating Gut and Digestive Health After Use of a Dietary Supplement System

An Eight-week Clinical Study for the Measurement of Gut and Digestive Health Parameters Before and After the Use of a Dietary Supplement System

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: SF Research Institute, Inc. · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This clinical research study is being conducted to evaluate gut and digestive health before and after the use of a dietary supplement system over an eight-week period. Gut and digestive health play an important role in overall health, including digestion, nutrient absorption, immune function, and metabolic balance. Changes in gut microbiota, inflammation, and intestinal barrier function may contribute to digestive symptoms such as bloating, discomfort, altered bowel habits, and reduced well-being. In this study, adult men and women with self-reported gastrointestinal symptoms will consume a dietary supplement system daily for eight weeks. The study will measure changes in gut and digestive health using objective stool-based laboratory biomarkers and validated symptom questionnaires. Stool samples will be collected at baseline and at the end of the study to evaluate markers related to microbial diversity, inflammation, immune activity, digestive function, and intestinal barrier integrity. Participants will also complete questionnaires throughout the study to assess gastrointestinal symptoms and subjective digestive health and well-being. The study will also monitor the safety and tolerability of the dietary supplement system during the study period.

Detailed description

This is a prospective, open-label, single-arm clinical study designed to evaluate changes in gut and digestive health parameters following daily use of a dietary supplement system over an eight-week period. Gut and digestive health are essential to overall human health and are closely associated with immune regulation, nutrient absorption, metabolic function, and systemic inflammation. The gastrointestinal tract contains a complex microbial ecosystem that supports digestion, produces bioactive metabolites, and modulates immune responses. Disruptions in gut microbiota composition, intestinal barrier integrity, and immune balance have been associated with digestive symptoms, inflammation, and reduced well-being. This study will enroll approximately 50 adult male and female subjects between 18 and 80 years of age who meet all inclusion and exclusion criteria, including self-reported gastrointestinal symptoms as assessed by the Gastrointestinal Symptom Rating Scale (GSRS). All participants will consume the study product daily for a total of eight weeks while maintaining their usual diet and lifestyle habits, as outlined in the protocol. The dietary supplement system consists of two study products that contain a combination of plant-derived nutrients, fibers, probiotics, digestive enzymes, and antioxidant-rich botanical ingredients. These components are intended to support gut microbial diversity, digestive processes, immune balance, and intestinal barrier integrity. Objective assessments of gut and digestive health will be conducted using stool-based laboratory evaluations at baseline and at the end of the study. These assessments include biomarkers related to microbial diversity, inflammation and immune activity (such as calprotectin, beta-defensin 2, and secretory IgA), digestive health markers (including short-chain fatty acids, bile acids, and malabsorption markers), and markers associated with intestinal barrier integrity and permeability. Participant-reported outcomes will be collected using validated questionnaires, including the Gastrointestinal Symptom Rating Scale (GSRS) and a Subjective Digestive Health and Well-Being Questionnaire. These assessments will be administered at baseline and at regular intervals throughout the study to evaluate changes in gastrointestinal symptoms, digestive comfort, overall well-being, and product tolerability. Safety assessments will be conducted throughout the study period, including monitoring of adverse events, concomitant medications, and study product compliance. The overall safety and tolerability of the dietary supplement system will be evaluated based on reported adverse events and clinical assessments.

Conditions

• Gastrointestinal Symptoms
• Digestive Health
• Gut Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	PhytoPower 1 and PhytoPower 2	The intervention consists of a dietary supplement system comprising two study products, PhytoPower 1 and PhytoPower 2. Participants will be instructed to mix one stick pack of PhytoPower 1 and one stick pack of PhytoPower 2 together in 16 fl. oz. of water and consume the prepared mixture once daily in the morning, with or without food, for a total duration of 8 weeks (56 days). Study products will be dispensed at the Baseline Visit and again at the Week 4 Visit in quantities sufficient to last until the next scheduled visit.

Timeline

• Start date: 2026-02-05
• Primary completion: 2026-04-06
• Completion: 2026-04-21
• First posted: 2026-02-19
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States