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

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.

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Symptoms; Gut Health; Digestive Health
• Intervention / Treatment: Dietary supplement: PhytoPower 1 and PhytoPower 2

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. John Ademola; Phone Number: 415-845-4638; Email: jademola@sfinstitute.com

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94132
      • Recruiting
      • San Francisco Research Institute
      • Contact: Khaleeq Rehman; Phone Number: 415-690-9641; Email: khaleeqr.sfinstitute@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 1. Male or female adults aged 18 to 80 years (considering 50% men and 50% women, even breakdowns in age groups 18-30, 31-60, 61-80 years, and 12-15% African American required) at the time of screening.

  2. Willing and able to provide written informed consent before participation in any study-related procedures.

  3. Willing and able to comply with all study procedures, including clinic visits, completion of questionnaires, and stool sample collection at predetermined time points.

  4. Willing to collect and provide stool samples, either in-clinic or at home as instructed.

  5. Willing to abstain from alcohol consumption (including beer, wine, and spirits) for the duration of the study.

  6. Proficient in written and spoken English. 7. Willing to provide a valid email address and mobile phone number and able to complete electronic forms and questionnaires using a smartphone.

  8. Able and willing to travel to the Research Institute for in-clinic visits and stool sample collection as scheduled.

  9. No known food allergies, based on subject self-report. 10. Willing to maintain usual diet and lifestyle habits, except as required by the study protocol.

  11. Subjects with self-reported gastrointestinal symptoms, defined as a baseline Gastrointestinal Symptom Rating Scale (GSRS) score ≥ 8 (35 subjects) and score ≤ 3 (5 subjects).

Exclusion Criteria:

• 1. Known allergy or hypersensitivity to any ingredient(s) of the study product or other herbal products.

  2. Presence or history of any medical condition that may interfere with study participation or outcome interpretation, including but not limited to:

  • Malabsorption disorders
  • Chronic gastrointestinal diseases
  • Severe depression

  • Clinically significant cardiovascular disease within the past 3 months 3. Pregnant, breastfeeding, or planning to become pregnant during the study period, based on subject self-report.

    4. Having a pregnant partner or a partner who is planning to become pregnant during the study period and is unwilling or unable to use an acceptable method of contraception.

    5. History of any cancer within the past 5 years. 6. Active or occasional smoking. 7. Current use of probiotics, unless willing to discontinue use at least 4 weeks prior to study enrollment.

    8. History of weight loss surgery or any type of bowel surgery, including resection or colectomy.

    9. Any active infection within the past 3 months requiring antibiotics, antiviral medication, or hospitalization.

    10. Use of immunosuppressive medications within the past 12 months, including systemic corticosteroids or biologic agents.

    11. History of seizure disorder or use of seizure medication within the past 4 weeks.

    12. History of HIV infection or solid organ transplantation. 13. Use of medications for chronic gastrointestinal or digestive conditions, including but not limited to:

  • Proton pump inhibitors or antacids (e.g., omeprazole, Prilosec®)
  • Laxatives or gastrointestinal motility agents
  • Medications for irritable bowel syndrome (IBS), Crohn's disease, or history of hospitalized diverticulitis 14. Any other condition that, in the opinion of the Principal Investigator, would make the subject unsuitable for participation or compromise subject safety or study integrity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dietary Supplement Group; Participants in this single-arm study will receive a dietary supplement system consisting of two study products, PhytoPower 1 and PhytoPower 2, administered once daily for 8 weeks. Participants will be instructed to mix one stick pack of PhytoPower 1 and one stick pack of PhytoPower 2 into 16 fl. oz. of water and consume the prepared mixture every morning, with or without food. The study will evaluate changes in gut and digestive health parameters using stool-based biomarkers and validated gastrointestinal symptom questionnaires over the study period.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gut Microbial Diversity	Mean change from baseline to Week 8 in gut microbial diversity assessed using stool-based analysis as part of the Gut Zoomer® test.	Baseline (Day 1) to Week 8 (End of Study)
Change in Digestive Function Biomarkers	Mean change from baseline to Week 8 in digestive health biomarkers (short-chain fatty acids) assessed using stool-based analysis.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Calprotectin Concentration from Baseline to Week 8	Mean change from baseline to Week 8 in stool calprotectin concentration, a marker of intestinal inflammation, measured using the Gut Zoomer® test.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Beta-Defensin 2 Concentration from Baseline to Week 8	Mean change from baseline to Week 8 in stool beta-defensin 2 concentration, an intestinal immune marker, measured using the Gut Zoomer® test.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Secretory Immunoglobulin A (sIgA) Concentration from Baseline to Week 8	Mean change from baseline to Week 8 in stool secretory Immunoglobulin A (sIgA) concentration, an intestinal immune marker, measured using the Gut Zoomer® test.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Bile Acid Concentration From Baseline to Week 8	Mean change from baseline to Week 8 in stool bile acid concentration assessed using stool-based analysis.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Malabsorption Marker Concentration From Baseline to Week 8	Mean change from baseline to Week 8 in stool-based markers of malabsorption assessed using stool-based analysis.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Lipopolysaccharide (LPS) Concentration From Baseline to Week 8	Mean change from baseline to Week 8 in stool lipopolysaccharide (LPS) concentration assessed using stool-based analysis.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Zonulin Concentration From Baseline to Week 8	Mean change from baseline to Week 8 in stool zonulin concentration assessed using stool-based analysis.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Tissue Transglutaminase (tTG) Concentration From Baseline to Week 8	Mean change from baseline to Week 8 in stool tissue transglutaminase (tTG) concentration assessed using stool-based analysis.	Baseline (Day 1) to Week 8 (End of Study)
Mean Change in Stool Anti-Gliadin Antibody Concentration From Baseline to Week 8	Mean change from baseline to Week 8 in stool anti-gliadin antibody concentration assessed using stool-based analysis.	Baseline (Day 1) to Week 8 (End of Study)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Gastrointestinal Symptom Rating Scale (GSRS) Score	To evaluate changes in gastrointestinal symptoms, including abdominal pain, reflux, indigestion, bloating, constipation, and diarrhea, as measured by the validated Gastrointestinal Symptom Rating Scale (GSRS). The GSRS is a patient-reported questionnaire using a 7-point Likert scale, with higher scores indicating greater symptom severity.	Baseline, Week 2, Week 4, Week 6, and Week 8
Change in Subjective Digestive Health and Well-Being Questionnaire Scores	To assess participant-reported changes in digestive comfort, overall well-being, energy levels, mood, skin health, mental clarity, product tolerability, and user experience using a custom Subjective Digestive Health and Well-Being Questionnaire administered throughout the study.	Baseline, Week 2, Week 4, Week 6, and Week 8
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Incidence, severity, and relationship to study product of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported during the 8-week study period.	Baseline, Week 2, Week 4, Week 6, and Week 8

Collaborators and Investigators

• Sponsor: SF Research Institute, Inc.
• Collaborators: Life Vantage

Study record dates

Study Major Dates

• Study Start (Estimated): February 5, 2026
• Primary Completion (Estimated): April 6, 2026
• Study Completion (Estimated): April 21, 2026

Study Registration Dates

• First Submitted: February 12, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 19, 2026

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Probiotics; Stool biomarkers; Subjective digestive health; Gut Zoomer stool test
• Other Study ID Numbers: LV-GUT-CT-01-26

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No